iTeh Standards logo
EURUSD
Your shopping cart is empty.

11.120.99 - Other standards related to pharmaceutics

ICS 11.120.99 Details

Other standards related to pharmaceutics

Weitere Aspekte der Pharmazie

Autres normes relatives a la pharmacie

Drugi standardi v zvezi s farmacijo

General Information

Parent
11.120 - Pharmaceutics

Frequently Asked Questions

ICS 11.120.99 is a classification code in the International Classification for Standards (ICS) system. It covers "Other standards related to pharmaceutics". The ICS is a hierarchical classification system used to organize international, regional, and national standards, facilitating the search and identification of standards across different fields.

There are 139 standards classified under ICS 11.120.99 (Other standards related to pharmaceutics). These standards are published by international and regional standardization bodies including ISO, IEC, CEN, CENELEC, and ETSI.

The International Classification for Standards (ICS) is a hierarchical classification system maintained by ISO to organize standards and related documents. It uses a three-level structure with field (2 digits), group (3 digits), and sub-group (2 digits) codes. The ICS helps users find standards by subject area and enables statistical analysis of standards development activities.

e-Library Subscription

Create subscription and get permanent access to documents within 11.120.99 - Other standards related to pharmaceutics

Type
Monthly Subscription
for
seat
×
$ 123.40
$ 123.40

Currently subscription includes documents marked with .We are working on making all documents available within the subscription.

Standardization Organization
Technical Committee
Directive
Mandate
50
ASTM
ASTM D8452-24(Guide)
Standard Guide for Medical-related Professionals within the Cannabis and Hemp Industries

SIGNIFICANCE AND USE
5.1 As patient use of cannabis and hemp for medical purposes increases and medical professionals are increasingly called upon to provide medical advice, the following requirements and expectations within the medical profession are increasingly significant, requiring:  
5.1.1 Availability by patients to qualified medical professionals who can provide safe and objective advice on the medical use of cannabis and hemp,  
5.1.2 Clarity by medical professionals on the legal restrictions in their area of jurisdiction to ensure compliance, and  
5.1.3 Development of qualified training and certificate programs to ensure safe and quality healthcare for patients.  
5.2 The primary objectives of this guide are as follows:  
5.2.1 Provide a general overview of the BoK required for the professions listed in Section 7; and  
5.2.2 Provide recommendations to form the foundation for training and subsequent recognition/certificate systems that enable consumers, employers, organizational management, government agencies, and others who rely upon medical professionals to distinguish between qualified and non-qualified workers.  
5.2.3 Recommend requirements that agencies can use to develop and document the specific criteria used for training or certificate programs.  
5.3 Users of this guide shall document deviations from the recommended requirements to inform their clients of the criteria applied in either the training or the certificate programs offered. As the cannabis and hemp industries and medical guidelines mature, this guide will be updated to reflect current thinking and requirements.  
5.4 The Bok elements are applicable to certificate programs, while the BoK, experiential and educational elements are applicable to certification process requirements.
SCOPE
1.1 This guide can provide certification bodies, training providers, employers, and certificate issuers, with best-practice guidance for administering their respective programs for medical-related professions within the cannabis and hemp industries.  
1.2 This guide recommends requirements for experience, training, education, and the body of knowledge (BoK) necessary for medical-related professions within the cannabis and hemp industries listed in Table 1.  
1.3 For purposes of this guide, a medical professional is defined as a person qualified and licensed as required by the jurisdiction to provide guidance or recommendations regarding a person's health or fitness.  
1.4 This guide provides recommendations for articulating professional requirements for training and education or earning certificates. It is part of a series of guides denoting certification requirements for professions within the cannabis and hemp industries (Guides D8346, D8347, D8348), and supporting Practice D8403 for associated certificate programs.  
1.5 This guide's content does not supersede requirements for training or earning a certificate defined by jurisdictional entities such as government or other regional regulatory bodies.  
1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

  • Guide
    4 pages
    English language
    sale 15% off
  • Guide
    4 pages
    English language
    sale 15% off
ASTM
ASTM E2810-23(Practice)
Standard Practice for Demonstrating Capability to Comply with the Test for Uniformity of Dosage Units

SIGNIFICANCE AND USE
4.1 The methodology was originally developed (1-4)6 for use in drug content uniformity and dissolution but has general application to any multistage test with multiple acceptance criteria. Practice E2709 summarizes the statistical aspects of this methodology. This practice applies the general methodology of Practice E2709 specifically to the UDU test.  
4.1.1 While other methods can be used to estimate the probability of passing the UDU test, they are outside the scope of this practice.  
4.2 The UDU test procedure describes a two-stage sampling test, where at each stage one can pass or continue testing, and the decision to fail is deferred until the second stage. At each stage there are acceptance criteria on the test results as outlined in Table 1.    
4.3 The UDU test is a market standard. The USP General Notices include the following statement about compendial standards. “The similarity to statistical procedures may seem to suggest an intent to make inference to some larger group of units, but in all cases, statements about whether the compendial standard is met apply only to the units tested.” Therefore, the UDU procedure is not intended for inspecting uniformity of finished product for lot/batch release or as a lot inspection procedure.  
4.3.1 The UDU test defines a product requirement to be met at release and throughout the shelf-life of the product.  
4.3.2 Passing the UDU test once does not provide statistical assurance that a batch of drug product meets specified statistical quality control criteria.  
4.4 This practice provides a practical specification that may be applied when uniformity of dosage units is required. An acceptance region for the mean and standard deviation of a set of test results from the lot is defined such that, at a prescribed confidence level, the probability that a future sample from the lot will pass the UDU test is greater than or equal to a prespecified lower probability bound. Having test results fall in the acceptance r...
SCOPE
1.1 This practice provides a general procedure for evaluating the capability to comply with the Uniformity of Dosage Units (UDU) test. This test is given in General Chapter  Uniformity of Dosage Units of the USP, in 2.9.40 Uniformity of Dosage Units of the Ph. Eur., and in 6.02 Uniformity of Dosage Units of the JP, and these versions are virtually interchangeable. For this multiple-stage test, the procedure computes a lower bound on the probability of passing the UDU test, based on statistical estimates made at a prescribed confidence level from a sample of dosage units.  
1.2 This methodology can be used to generate an acceptance limit table, which defines a set of sample means and standard deviations that assures passing the UDU test for a prescribed lower probability bound, confidence level, and sample size.  
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

  • Standard
    20 pages
    English language
    sale 15% off
  • Standard
    20 pages
    English language
    sale 15% off
ASTM
ASTM D8270-23b(Terminology)
Standard Terminology Relating to Cannabis

SCOPE
1.1 This terminology is a compilation of definitions of technical terms used in the cannabis industry. Terms that are generally understood or adequately defined in other readily available sources are not included.  
1.2 When a term is used in an ASTM document for which Committee D37 is responsible it is included only when judged, after review by Subcommittee D37.91, to be a generally usable term.  
1.3 Definitions that are identical to those published by other ASTM committees or other standards organizations are identified with the committee number (for example, D20) or with the abbreviation of the name of the organization (for example, IUPAC, International Union of Pure and Applied Chemistry).  
1.4 A definition is a single sentence with additional information included in discussions.  
1.5 Definitions are followed by the committee responsible for the standard(s) (for example, [D37.01]) and standard designation(s) in which they are used (for example, D8219).  
1.6 Abbreviated Terminology:  
1.6.1 Abbreviated terminology is intended to provide uniform contractions of terms relating to cannabis that have evolved through widespread common usage. The compilation in this standard has been prepared to avoid the occurrence of more than one abbreviated term for a given cannabis term and to avoid multiple meanings for abbreviated terms.  
1.6.2 The abbreviated terminology and descriptions in this standard are intended to be consistent with usage in the cannabis industry and the standards under D37 jurisdiction. Other ASTM committees may assign a different word-phrase description to the same abbreviated terminology. In such cases, the abbreviated terms in this standard shall apply to usage in D37 standards, or if widespread misunderstanding could result from conflicting abbreviated terminology descriptions, the abbreviated terminology for the word-phrase shall not be used in D37 standards.  
1.6.3 Acronyms and Initialisms—A word formed from the letters or parts of words of a longer word-phrase, usually from the initial letters or parts of the words. An acronym is pronounced as a word (for example, radar for radio detection and ranging). An initialism is pronounced as a series of letters (for example, DOT for Department of Transportation).  
1.6.4 The acronym or initialism description is the origin word-phrase for the acronym or initialism, not a definition.  
1.7 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.8 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

  • Standard
    5 pages
    English language
    sale 15% off
  • Standard
    5 pages
    English language
    sale 15% off
ASTM
ASTM D8498-23(Guide)
Standard Guide for Compliance to the Specifications of ASTM D8450

SIGNIFICANCE AND USE
4.1 Standards and practices for assuring safety, quality, and weight stabilization during key steps of the cannabis/hemp flowers sojourn are in order.  
4.2 This guide is intended to assist in assuring safety, quality, and weight stabilization of cannabis/hemp flower during indoor packaging operations.  
4.3 This guide is intended to assist in assuring that packaged cannabis/hemp flower has a water activity of 0.55 to 0.65 per Specification D8197.  
4.4 This guide is intended to be used by purveyors who move the cured crop to consumer or non-consumer packaging used for distribution.
SCOPE
1.1 Specification D8450 specifies the environmental conditions, such as temperature, humidity, and lighting under which the cured, dry, cannabis/hemp flowers in fresh format intended for human use are to be packaged to assure the safety, quality, and weight stabilization of the packaged flower. This guide suggests means by which the packager of cannabis/hemp can meet Specification D8450.  
1.1.1 This guide does not apply to frozen cannabis/hemp.  
1.1.2 This guide does not apply to cannabis/hemp intended for extraction.  
1.2 This guide applies only to controlling an indoor environment (heat, cooling, humidity control, lighting) surrounding packaging operations. Outdoor operations are outside the scope of this guide and are not addressed.  
1.3 This guide can be used by licensed operators in the cannabis/hemp space who move the cured crop(s) into consumer or non-consumer packaging used for distribution.  
1.4 Security of the cannabis/hemp flower during the packaging process is not within the scope of this guide.  
1.5 This guide is intended to remain valid until the packaged cannabis/hemp flower is placed in storage or transit.  
1.6 Authorities having jurisdiction may have additional or alternate requirements which shall take precedence or supersede this guide.  
1.7 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.8 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

  • Guide
    3 pages
    English language
    sale 15% off
ASTM
ASTM D8499-23(Guide)
Standard Guide for Meeting the Specifications of ASTM D8432

SIGNIFICANCE AND USE
4.1 Standards and practices for assuring safety, quality, and weight stabilization during key steps of the cannabis/hemp flowers’ sojourn are in order.  
4.2 This standard is intended to assure safety, quality, and weight stabilization of packaged cannabis/hemp flower during transit operations.  
4.3 This standard is intended to be used by purveyors who move the packaged cured flower between licensed operators or to the end user.  
4.4 This standard is intended to be used by samplers and testing laboratories transporting samples to a laboratory to assure that samples analyzed represent as accurately as possible, the material that was gathered to provide the sample for analysis.
SCOPE
1.1 Specification D8432 covers the environmental conditions, such as temperature, humidity, and lighting under which the cured, dry, cannabis/hemp flowers packaged in fresh format and intended for human use can be maintained in transit to assure the safety, quality, and weight stabilization of the packaged flower. This guide suggests means by which the purveyor of transportation of cannabis/hemp can meet those specifications.  
1.1.1 This standard does not apply to frozen cannabis/hemp.  
1.1.2 This standard does not apply to cannabis/hemp intended for extraction.  
1.2 This standard applies to controlling the environment surrounding packaged cannabis/hemp flower in transit, either within the package itself or in the environment surrounding the package, or both.  
1.3 This standard is to be followed by licensed operators in the cannabis/hemp space who move the packaged crop(s) through the distribution supply chain to another licensed operator or to the end user.  
1.4 Purveyors of cannabis/hemp flower include, but are not necessarily limited to: the packager, transportation companies, warehousing operations, and retail operations.  
1.5 Security of the packaged cannabis/hemp flower while in transit is not within the scope of this standard.  
1.6 This standard is intended to remain valid until ownership of the packaged cannabis/hemp flower is transferred to another licensed operator or to the final consumer.  
1.7 Authorities having jurisdiction may have additional or alternate requirements which shall take precedence or supersede this standard.  
1.8 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.9 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

  • Guide
    4 pages
    English language
    sale 15% off
ASTM
ASTM D7709-12(2023)(Test Method)
Standard Test Methods for Measuring Water Vapor Transmission Rate (WVTR) of Pharmaceutical Bottles and Blisters

SIGNIFICANCE AND USE
5.1 The purpose of these test methods is to obtain reliable values for WVTR that can be used to discriminate among barrier packages for pharmaceutical products. These test methods will establish a WVTR value that represents the water vapor transmission of the container closure system being evaluated. They are intended for use in evaluating or comparing, or both, the water vapor barrier performance of alternative packages for use in packaging of pharmaceutical products.  
5.2 While these methods were developed for a specific, limited application, they should be suitable for most types and sizes of consumer packages.
SCOPE
1.1 The three test methods described herein are for measurement of water vapor transmission rates (WVTRs) of high-barrier multiple-unit containers (bottles), high-barrier single-unit containers (blisters), and quasi-barrier single-unit containers used for packaging pharmaceutical products. The containers are tested closed and sealed. These test methods can be used for all consumer-sized primary containers and bulk primary containers of a size limited only by the dimensions of the equipment and the weighing capacity and sensitivity of the balance.  
1.2 These test methods are intended to be of sufficient sensitivity and precision to allow clear discrimination among the levels of barrier packages currently available for pharmaceutical products.  
1.3 There are three methods: Method A is for bottles, Method B is for formed barrier blisters, and Method C is for formed quasi-barrier blisters. Methods B and C can be adapted for use with flexible pouches.  
1.4 These test methods use gravimetric measurement to determine the rate of weight gain as a result of water vapor transmission into the package and subsequent uptake by a desiccant enclosed within the package. The packages are exposed to environments typical of those used for accelerated stability testing of drug products in the package (typically 40 °C/75 % relative humidity [RH]).  
1.5 For these methods, balance sensitivity, amount of desiccant, number of blisters per test unit, and weighing frequency were developed in an experiment based on Test Methods E96/E96M.  
1.6 Test Methods E96/E96M gives specific instruction on the interactions among weighing frequency, number of data points necessary to establish steady state, minimum weight gain in a weighing period, and balance sensitivity.  
1.7 The test methods in this standard were developed specifically for pharmaceutical bottles and blisters as closed container-closure systems. The experiment from which the methods were developed provided an inter-laboratory study from which the precision and bias statement was written. The packages in the study were small bottles and blisters used regularly for pharmaceutical solid oral dosage forms.  
1.8 In spite of the specific nature of their application, the test methods in this standard should be suitable for other pharmaceutical packages and most types and sizes of other consumer packages.  
1.9 The values stated in SI units are to be regarded as the standard. No other units of measurement are included in this standard. The units of measure for bottles are milligrams per bottle per day (mg/bottle-day) and for blisters, milligrams per blister cavity per day (mg/cavity-day). These units may be used for both standard and referee testing.  
1.10 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.11 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Ba...

  • Standard
    7 pages
    English language
    sale 15% off
ASTM
ASTM D8500-23(Guide)
Standard Guide for Meeting the Specifications of ASTM D8423

SIGNIFICANCE AND USE
4.1 Standards and practices for assuring safety, quality, and weight stabilization during key steps of the cannabis/hemp flowers’ sojourn are in order.  
4.2 This standard is intended to assure safety, quality, and weight stabilization of packaged cannabis/hemp flower during storage.  
4.3 This standard is intended to be used by purveyors who store the packaged cured flower between packaging and subsequent transfer to other licensed operators or to the end user.  
4.4 This standard is intended to be used by samplers and testing laboratories storing samples prior to laboratory analyses to assure that samples analyzed represent as accurately as possible, the material that was gathered to provide the sample for analysis.
SCOPE
1.1 Specification D8423 covers the environmental conditions, such as temperature, humidity, and lighting under which the cured dry cannabis/hemp flowers packaged in fresh format and intended for human use can be maintained in storage to assure the safety, quality, and weight stabilization of the packaged flower. This guide suggests means by which the purveyor of storage of cannabis/hemp can meet those specifications.  
1.1.1 This standard does not apply to frozen cannabis/hemp.  
1.1.2 This standard does not apply to cannabis/hemp intended for extraction.  
1.2 The standard applies to controlling the environment surrounding packaged cannabis/hemp flower during storage, either within the package itself or in the environment surrounding the package, or both.  
1.3 This standard is to be followed by licensed operators in the cannabis/hemp space who move the packaged crop(s) through the distribution supply chain to another licensed operator or to the end user.  
1.4 Purveyors of cannabis/hemp flower include, but are not necessarily limited to: the packager, transportation companies, warehousing operations, and retail operations.  
1.5 Security of the packaged cannabis/hemp flower while in storage is not within the scope of this standard.  
1.6 This standard is intended to remain valid until ownership of the packaged cannabis/hemp flower is transferred to another licensed operator or to the final consumer.  
1.7 Authorities having jurisdiction may have additional or alternate requirements which shall take precedence or supersede this standard.  
1.8 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.9 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

  • Guide
    4 pages
    English language
    sale 15% off
CEN
EN ISO 14375:2023(Main)
Child-resistant non-reclosable packaging for pharmaceutical products - Requirements and testing (ISO 14375:2018)
SIST EN ISO 14375:2023

This document specifies performance requirements and methods of test for non-reclosable packaging that have been designated child-resistant. This document is intended for type approval only (see 3.5) and is not intended for quality assurance purposes.

  • Standard
    22 pages
    English language
    e-Library read for
    1 day
ASTM
ASTM D8399-23(Test Method)
Standard Test Method for Multi-residue Analysis of Pesticides in Dried Cannabis and Hemp Raw Materials Using Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS)

SIGNIFICANCE AND USE
5.1 The analysis and reporting of pesticide content in all forms of cannabis raw material that is grown or processed or both, with the intent of ingestion or consumption, is required to address health and safety concerns, satisfy testing and labeling requirements, and meet the regulatory guidelines of various jurisdictions where cannabis has been legalized for ingestion or consumption for medicinal or recreational purposes, or both. This test method is useful in providing quantitative results for the analytes listed in Table 1, which is a subset of the pesticide testing requirements found in regulatory documents for cannabis, not limited to and including Canada, many U.S. states where legalization has occurred, and the European Pharmacopeia (1-4). This test method may be appropriate for additional pesticide and growth regulator analytes, which may be added to those of Table 1 provided validation is performed in accordance with Practice D8282. Analytes may be removed from Table 1 without additional validation.
SCOPE
1.1 This test method allows for the concentration determination of the pesticides listed in Table 1 and shall apply to any dried raw material from a cannabis plant (Note 1, Note 2) regardless of the type of cannabis plant from which it was derived (1, 2).2 For the sake of brevity, the term “cannabis” shall be used from now on to refer to any type of cannabis plant including those which can be classified as hemp. The procedure includes sub-sampling a ground, homogenous sample, liquid-solid extraction with acetonitrile:acetic acid (100:1, v:v), solid phase extraction with C18 SPE media, dilution in 3 mM ammonium formate in water with 0.1 % formic acid and 3 mM ammonium formate in methanol with 0.02 % formic acid in a 20:80 ratio (v:v) and analysis by LC-MS/MS. This procedure encompasses the entire process from sample preparation to analyte quantitation encompassing a range of 0.005 µg/g to 0.500 µg/g.  
Pyrethrins = Pyrethrin I and II
Spinetoram = Spinetoram J and L
Spinosad = Spinosyn A and D
Note 1: For this test method, dried raw material from a cannabis plant includes one or more of inflorescence, leaves, or stems.
Note 2: Certain jurisdictions or regulations may require specific parts of the plant to be included or excluded for analysis and those regulations will take precedence for the selection of plant parts.  
1.2 Units—The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.3 Table 1 lists the analytes measured by this test method.  
1.4 No recommendations found within this test method shall preclude observance of federal, state, or local regulations, which may be more restrictive or have different requirements.  
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

  • Standard
    16 pages
    English language
    sale 15% off
  • Standard
    16 pages
    English language
    sale 15% off
ASTM
ASTM D8375-23(Test Method)
Standard Test Method for Determination of Cannabinoid Concentration in Dried Cannabis and Hemp Raw Materials using Liquid Chromatography Tandem Mass Spectrometry (LC-MS/MS)

SIGNIFICANCE AND USE
5.1 The analysis and reporting of cannabinoid content in cannabis and hemp is required to address human health and safety concerns, satisfy testing and labeling requirements, and meet the regulatory guidelines of various jurisdictions. This test method is useful in providing quantitative results for up to seventeen cannabinoids in dried cannabis and hemp raw material samples.
SCOPE
1.1 This test method allows for the concentration determination of the cannabinoids listed in Table 1, and shall apply to any dried raw material from a cannabis plant (Note 1, Note 2) regardless of the type of cannabis plant from which it was derived.2 For the sake of brevity, the term “cannabis” shall be used from now on to refer to any type of cannabis plant including those that can be classified as hemp. The procedure includes sub-sampling a ground, homogeneous sample, extraction with methanol:water (80:20, v:v),3,4 dilution in methanol and analysis by liquid chromatography tandem mass spectrometry (LC-MS/MS). The method allows for a wide-range of sample concentrations to be determined by using a 1000-fold calibration range and the option to perform multiple levels of sample dilution. The calibration curve is prepared in methanol over a range of 10 ng/mL to 10 000 ng/mL for all seventeen cannabinoids, or a subset of cannabinoids if desired, while the sample extracts are diluted in methanol into the calibration range.3,4,5 For example, a 1/500 dilution of sample extracts allows concentration determination over a range of 0.5 mg/g to 500 mg/g in cannabis. The method was validated with quality control samples prepared in methanol, a candidate certified reference material (CRM), and repeat extraction and analysis of cannabinoid samples.3  
Note 1: For this test method, dried raw material from a cannabis plant includes one or more of inflorescence, leaves, or stems.
Note 2: Certain jurisdictions or regulations may require specific parts of the plant to be included or excluded for analysis and those regulations will take precedence for the selection of plant parts.  
1.2 Units—The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.3 List of Measurable Analytes—See Table 1.  
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

  • Standard
    17 pages
    English language
    sale 15% off
  • Standard
    17 pages
    English language
    sale 15% off
ISO
ISO 23416:2023(Main)
General specifications and testing methods for temperature-sensitive medicinal packages in good distribution practice principles

This document describes the general specifications of temperature-sensitive medicinal packaging based on the principles of good distribution practice (GDP). It also specifies test methods to validate the package performance for temperature-sensitive medicinal products. This covers the procedures of temperature-recording and testing methods on the performance of insulated containers such as dimensions, weights, storage capacity and robustness in temperature-controlling. This document does not guarantee the quality and safety of all medicinal products. Under special circumstances where the weight or the characteristics of the products and environment show specific conditions, agreements are followed. This document does not cover the active packaging system, but only covers the passive packaging system able to control the desired temperature without any power sources.

  • Standard
    16 pages
    English language
    sale 15% off
ASTM
ASTM D8493-23(Guide)
Standard Guide for Sample Preparation of Cannabis and Hemp Inflorescence for Laboratory Analysis

SIGNIFICANCE AND USE
5.1 The sample preparation procedure for comminution impacts other downstream processes such as extraction and sonication, which ultimately affects the total analytical error (TAE) and measurement uncertainty.  
5.2 Factors that may influence the sample preparation process include the prevention of cross-contamination (carryover) from a prior sample and an inadequate cleaning procedure between preparation of samples, poor sample handling, storage (sample preservation), and moisture content (drying methods) of plant material being greater than 15 % (15). Samples with high moisture content are hard to process completely and may yield lower analyte (that is, cannabinoid) concentration during extraction and further processing. Lastly, water activity Specification D8197 is recommended, activity (aw) range (0.55 to 0.65) for dry cannabis or hemp flower or both.  
5.3 There are many different types of hardware technologies that address the comminution of dried cannabis or hemp; however, the list of devices is exhaustive and thus beyond the scope of this guide. See Table 3 and Table 4  (16-18) for a summary of different milling technologies. Distinctions among various pieces of equipment often relate to the type, mass, and size/shape of the sample (dry, fibrous) for which each is most effective. In addition, there may be economic reasons for mill selection, that is, the sample throughput of the testing laboratory (number of samples per day), access to cryogenics, and sample mass requirements.    
5.4 In addition to sampling devices, this guide does not include the sample preparation of edibles, tinctures, oils/concentrates, beverages, and so forth in which the sample diversity poses significant sample preparation challenges to be put forward in additional work items.  
5.5 The sample size for comminution purposes is limited as the analytical testing portion required is often 500 times smaller than the bulk sample lot and not every testing laboratory is equipped to handl...
SCOPE
1.1 In this guide, the basic steps in obtaining a test portion sample of either dried cannabis/hemp inflorescence are outlined.  
1.2 Sample preparation depends on many factors including moisture (dryness) of the sample, the analyte to be measured, the concentrations/amounts, and the test method's precision and accuracy requirements. In this case, dried cannabis or hemp plant material require particle size reduction-comminution from a representative sample of which the final analytical testing portion is determined by the employed testing method. Local regulatory guidelines often dictate both the representative sample that is taken from the bulk material (harvest batch) and the final mass of the test portion (for example  
1.3 This guide will not purport to meet every local and state jurisdiction since different regulatory requirements vary; the local/state requirements are at the discretion of the user to follow and interpret.  
1.4 Units—The values stated in SI units are to be regarded as the standard. No other units of measurement are included in this standard.  
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

  • Guide
    14 pages
    English language
    sale 15% off
ISO
IWA 37-3:2022(Main)
Safety, security and sustainability of cannabis facilities and operations - Part 3: Good production practices (GPP)

This document specifies requirements and recommendations for organizations directly or indirectly involved in the cannabis supply chain, to enable them to: - plan, implement, operate, maintain and update a good production practice programme for providing products that are safe, according to their intended use; - demonstrate compliance with applicable statutory and regulatory requirements; - evaluate and assess mutually agreed customer requirements and demonstrate conformity to them; - effectively communicate with interested parties and demonstrate conformity to relevant interested parties; - demonstrate conformity to stated policies in a cannabis quality programme (CQP) for product safety, product quality, product security and facility safety; - support the evaluation of quality programmes by external organizations or to permit self-assessment or self-declaration of adherence to some or all of the guidance contained in this document. All requirements in this document are generic and intended to be applicable to all organizations in the cannabis supply chain, regardless of size and/or complexity. Organizations that are directly or indirectly involved include (but are not limited to) growers/cultivators, harvesters, primary processors, producers of cannabis, manufacturers of cannabis derivatives, cannabis edibles and/or cannabis products, testing providers, retailers and organizations providing transportation, storage and distribution services, suppliers of equipment, packaging materials and other contact materials. This document intended to enable any organization, including small and/or less developed organizations, to implement externally developed elements in its CQP. NOTE 1 Organizations in the cannabis supply chain are diverse in nature and not all the requirements specified in this document apply to each establishment or process. Justifications for exclusions or the use of alternative measures can be documented by a risk assessment/hazard analysis or other appropriate means. This document provides guidance related to the following categories of cannabis, cannabis derivatives and cannabis products: - cannabis plant seeds; - cannabis plants; - fresh cannabis; - dried cannabis; - cannabis derivatives; - cannabis topicals; - inhalable cannabis. NOTE 2 Annex B provides additional guidance on applying GPP to cannabis edibles with respect to requirements and recommendations in existing food safety standards. Where buildings or premises combine cultivation and processing of cannabis plants, including ancillary activities, along with other operational activities, the requirements and recommendations in this document apply only to that portion of the facility. NOTE 3 Where joint use activities are present in a common building, specific statutory and regulatory requirements can apply for each category. This document does not address the following: - requirements related to research and development activities for finished products; - general fire prevention or building construction features that are normally a function of local building and fire codes where applicable; - premises used exclusively for operational activities, such as office space, call centres and retail outlets, used for the distribution, marketing, or sale of cannabis; NOTE 4 Shipping and receiving of products from the production facility for further distribution are not considered as a retail outlet. - the safe consumption or use of the cannabis or cannabis products produced by organizations applying these good production practices; - occupational health and safety requirements governing cannabis workers and personnel except as identified in A.8.4 and A.8.6; - the protection of the environment; - security of the supply chain monitoring system, including cybersecurity and notifications; NOTE 5 Security and monitoring of the supply chain are dealt with specifically in IWA 37-2. - outdoor cultivation of cannabis and industrial hemp; - gr

  • Standardization document
    66 pages
    English language
    sale 15% off
ASTM
ASTM D8439-22(Specification)
Standard Specification for Medicinal-use Cannabis Inflorescence

SCOPE
1.1 This standard defines the specifications (appropriate tests, their analytical methods and acceptance criteria) for the identification, strength (for example, cannabinoid content), and purity (for example, limits for contaminants) for medicinal-use cannabis inflorescence.  
1.2 This specification references approved analytical methods used to verify the specifications, and in the absence of approved analytical methods, a suggested method for validating such specifications.  
1.3 Units—The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

  • Technical specification
    7 pages
    English language
    sale 15% off
ISO
ISO 24166-1:2022(Main)
Snap-on bottles for metering pumps - Part 1: Tubular glass

This document specifies the shape, dimensions, fill capacities and performance requirements of tubular glass vials for metering pumps. It also specifies the material for the manufacturing of such containers as well as the secondary packaging. This document provides also requirements for packaging of the tubular glass vials and addresses nonsterile, ready to sterilize or sterile as three possible options. This document is applicable to colourless or amber containers made of tubular glass and intended to be used for packaging, storage or transportation of products intended for medicinal use.

  • Standard
    20 pages
    English language
    sale 15% off
ISO
ISO 24166-2:2022(Main)
Snap-on bottles for metering pumps - Part 2: Moulded glass

This document specifies the shape, dimensions, fill capacities and performance requirements of moulded glass bottles for metering pumps. It also specifies the material for the manufacturing of such containers as well as the secondary packaging. This document also provides requirements for packaging of the moulded glass bottles and addresses nonsterile, ready to sterilize or sterile as three possible options. This document is applicable to colourless or amber glass containers moulded from borosilicate or soda-lime-silica glass and intended to be used in the packaging, storage or transportation of products intended for medicinal use.

  • Standard
    17 pages
    English language
    sale 15% off
ISO
ISO 24166-3:2022(Main)
Snap-on bottles for metering pumps - Part 3: Plastic

This document specifies the shape, dimensions, fill capacities and performance requirements of plastic bottles for metering pumps. It also specifies the material for the manufacturing of such containers as well as the secondary packaging. The document provides requirements for packaging of the plastic bottles and addresses nonsterile, ready to sterilize or sterile as three possible options. This document is applicable to colourless or coloured containers moulded from plastic and intended to be used in the packaging, storage or transportation of products intended for medicinal use.

  • Standard
    18 pages
    English language
    sale 15% off
ASTM
ASTM D8469-22(Test Method)
Standard Test Method for Analysis of Multiple Elements in Cannabis Matrices by Inductively Coupled Plasma Mass Spectrometry (ICP-MS)

SIGNIFICANCE AND USE
5.1 Medical and/or recreational marijuana (cannabis) has been legalized for adult use in many countries and states within the USA (5). Many jurisdictions that permit the use of medicinal and recreational marijuana require testing of cannabis and associated products to ensure safety from contaminants, especially the toxic “big four” elements such as As, Cd, Hg, and Pb (6), and other metals worthy of consideration (6). These heavy metals can accumulate in plants grown in polluted soils or contamination can occur during the manufacturing process (7). In addition to ensuring product safety, the analysis of mineral and other trace elements is required for labeling purposes when these products are sold as nutritional supplements. Trace element analysis of plant and nutritional supplement materials is a well-established application (8). Following acidic digestion to break down the plant-based samples' primary components, ICP-MS is often used for quantitative analysis because of its multi-element capability, high sensitivity, speed, robustness, and wide dynamic range.  
5.2 This test method covers the rapid determination of multiple elements in cannabis sample digests. The elements include the priority toxic elements (As, Cd, Hg, and Pb), as well as elements required by some states and elements of interest in the cannabis community (V, Cr, Cu, Zn, Sb, Ba, Se, Ag, Na, Al, K, Mn, Fe, Co, Ni, Mo, Tl, Th, and U). Irrespective of the number of elements being measured, test times are approximately a few minutes per test specimen, and detectability for most elements is in the low- to sub-ppb range.
SCOPE
1.1 This test method uses inductively coupled plasma mass spectrometry (ICP-MS) to determine multiple trace elements in cannabis and cannabis-related matrices following sample preparation using microwave-assisted acid digestion. This test method is applicable to the quantification of trace levels of elements in dried plant materials, concentrates, oils, extracts, tinctures of cannabis and cannabis-related products. Other matrices may be added provided that the lab validates the extra matrices using Practice D8282. Details are provided on the validation of both the sample preparation procedure and analytical method using certified reference materials (CRMs) and validation of the analytical method using spike recovery testing of several cannabis based samples.  
1.2 This test method should be used by analysts experienced in the use of microwave digestion and ICP-MS, matrix interferences, and procedures for their correction or reduction, and should only be used by personnel trained in the handling, preparation, and analysis of samples for the determination of trace elements in cannabis and cannabis products (1).2 This test method was developed using a single quadrupole ICP-MS equipped with a collision/reaction cell (CRC) that can be pressurized with helium (He) gas for the removal of polyatomic interferences using kinetic energy discrimination (KED). This test method can also be run using a triple quadrupole or “tandem” mass spectrometer (MS/MS) ICP-MS instrument, which is fitted with CRC technology. The ICP-MS method accounts for polyatomic interferences, which are the most common spectral overlaps in ICP-MS, isobaric interferences, and any potential doubly-charged ion interferences (M2+) that may arise from the presence of rare earth elements (REEs) in the samples, as the REE2+ ion interferences can affect the accuracy of the measurement of arsenic (As) and selenium (Se) in the samples. Table 1 lists elements for which the test method applies along with recommended analytical masses, and secondary masses for some elements. The priority toxic elements arsenic (As), cadmium (Cd), mercury (Hg), and lead (Pb), also sometimes referred to as the “big four” toxic trace elements are listed separately because of their toxicity, as discussed in 5.1.  
1.3 Certified reference materials (CRMs) should be matrix matc...

  • Standard
    15 pages
    English language
    sale 15% off
ASTM
ASTM D8442-22(Test Method)
Standard Test Method for Determination of Cannabinoids in Cannabis Raw Materials and Resin Cannabis Products by Gas Chromatography and Flame Ionization Detection

SIGNIFICANCE AND USE
5.1 Gas chromatography and flame ionization detection provides a rapid means to identify and quantify cannabinoids in a variety of samples of interest. This test method allows producers of cannabis products to improve and optimize the quality of their products. For example, hemp extractors can use it to determine the efficiency of extraction processes and to verify that products meet regulatory requirements, ensuring safety and quality of products.  
5.2 Cannabinoids, such as CBD and THC can be monitored throughout the production process. The determination of Δ9-THC is often required for regulatory purposes and the determination of other THC isomers is often of interest. The United Nations Office on Drugs and Crime provides experimental details and guidance for use of GC to analyze cannabis related samples, including conditions suitable for decarboxylation of cannabinoid acids.3  
5.3 Post-decarboxylated methodology is used. In decarboxylation, heat is used to liberate carbon dioxide from carboxylic acid cannabinoids, forming their corresponding neutral cannabinoids, for example, THC from THCA. It should be recognized that the hot temperature of the GC injection port itself is capable of effecting at least some decarboxylation (250 °C – Table 2), and many sample types, such as distillates, require no decarboxylation because it would have occurred during material processing. Therefore, some knowledge of sample properties and material processing is useful. Resulting determinations are for the total cannabinoid content of specific isomers, for example, total Δ9-THC. For those samples requiring decarboxylation, the method is validated per Practice D8282 through the use of reference materials, spike and recovery of knowns, or through comparison with LC results. For example, carrying out the decarboxylation procedure of a standard containing known amounts of CBDA and CBN should yield the correct amounts of CBD and CBN, where CBN is not significantly changed and the mass...
SCOPE
1.1 This test method covers the analysis of cannabinoids in cannabis products by gas chromatography (GC) and flame ionization detection (FID).  
1.2 This test method is applicable to cannabis raw materials and resin cannabis products as defined in Guide D8245, including those from hemp. Such material includes: biomass; plant material; flowers; resins; extracts; distillates; recovered solvents; and other intermediate processing material. The applicable concentration range of analysis will vary to some extent depending on the nature of the sample, for instance measurement of delta-9-tetrahydrocannabinol (Δ9-THC) for regulatory purposes in hemp would require calibration to lower concentration levels compared to measurement of CBD in its isolate; however, in most cases, the test method is applicable to the determination of major and minor cannabinoids above about 0.1 mass% in concentration. Dilution of sample solutions is used to adjust concentrations to fall within appropriate calibration curves. Particular emphasis is placed on the determination of Δ9-THC for regulatory compliance purposes and control. This test method can measure any cannabinoid that is eluted and detected from a GC column with sufficient resolution from any interfering compounds. Typical cannabinoids of interest that can be determined by this test method are shown in Table 1. Use of an HPLC technique is recommended if individual measurement of acids, such as THCA, is required.  
1.3 The test method does not purport to identify all individual cannabinoids; however, individual users can adapt this test method for specific custom analyses to meet their needs.  
1.4 Units—Values stated in SI units are to be regarded as the standard. No other units of measurement are included in this standard.  
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard t...

  • Standard
    7 pages
    English language
    sale 15% off
ASTM
ASTM D8432-22(Specification)
Standard Specification for Environmental Conditions while In Transit for Packaged Cannabis/Hemp Flower

SCOPE
1.1 This standard specifies the environmental conditions, such as temperature, humidity, and lighting under which cannabis/hemp flowers packaged in fresh format and intended for human use are to be maintained in transit to ensure the safety and quality of the packaged flower.  
1.1.1 This specification does not apply to frozen cannabis/hemp.  
1.1.2 This specification does not apply to cannabis/hemp intended for extraction.  
1.2 This specification applies to controlling the environment surrounding packaged cannabis/hemp flower in transit.  
1.3 This specification is to be followed by licensed operators in the cannabis/hemp space who move the packaged crop(s) through the distribution supply chain to another licensed operator or to the end user.  
1.4 Security of the packaged cannabis/hemp flower while in transit is not within the scope of this specification.  
1.5 This specification is intended to remain valid until ownership of the packaged cannabis/hemp flower is transferred to another licensed operator or to the final consumer.  
1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

  • Technical specification
    3 pages
    English language
    sale 15% off
ASTM
ASTM D8423-22(Specification)
Standard Specification for Environmental Conditions for Post-packaged Storage and Retail Merchandising of Cannabis/Hemp Flower

SCOPE
1.1 This standard specifies the environmental conditions, such as temperature, humidity, and lighting under which cannabis/hemp flowers in fresh format intended for human use are packaged to be stored to ensure the safety, quality, and weight stabilization of the packaged flower.  
1.1.1 This specification does not apply to frozen cannabis/hemp.  
1.1.2 This specification does not apply to cannabis/hemp intended for extraction.  
1.2 This specification applies to controlling the environment surrounding packaged cannabis/hemp flower.  
1.3 This specification is to be followed by licensed operators in the cannabis/hemp space who move the packaged crop(s) through the distribution supply chain to another licensed operator or to the end user.  
1.4 Purveyors of cannabis/hemp flower include, but are not necessarily limited to: the packager, transportation companies, warehousing operations, and retail operations.  
1.5 Security of the packaged cannabis/hemp flower while in storage is not within the scope of this specification.  
1.6 This specification is intended to remain valid until ownership of the packaged cannabis/hemp flower is transferred to another licensed operator or to the final consumer.  
1.7 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.8 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

  • Technical specification
    3 pages
    English language
    sale 15% off
ASTM
ASTM D8398-22(Practice)
Standard Practice for Management Responsibilities in Managing a Quality Management System (QMS)

SIGNIFICANCE AND USE
4.1 This practice is for any cannabis operation to use as a fundamental part of a robust quality management system (QMS).  
4.2 Regulators can use this practice to develop regulations that require the implementation of QMS principles, specifically management’s role and responsibilities. Further, regulators can use this practice to help build a checklist to evaluate management’s engagement and compliance with QMS based regulations.  
4.3 Auditors would use this practice to assess the level of management engagement with an operations QMS.  
4.4 Any cannabis operation that has implemented or seeks to implement a QMS would use this practice.
SCOPE
1.1 This practice provides the management responsibilities for the implementation and oversight of a quality management system (QMS). It can be applied to all cannabis operations, including cultivation, manufacturing, labeling, dispensing, and distribution. This practice does not address the quality management system details, but rather focuses on the main considerations for management’s role in setting up a QMS. Guide D8222 provides an overview and some details about the components of a QMS. Other standards provide details on specific QMS components.  
1.2 The term GxP as used in this practice is meant to include those good practices in the activities included in 1.1; namely cultivation, manufacturing, distribution, and all the relevant functions associated with these activities (for example, purchasing, testing, storing, and so forth).  
1.3 Although this practice mentions the importance of health and safety, it is done so in the context of overall management responsibility. This practice does not address details of a health and safety system, but it identifies the importance of this as a management responsibility.  
1.4 This practice encompasses a single component of the QMS (management responsibilities) that, when combined with the other elements, satisfies the requirements of a complete QMS.  
1.5 The practices described in this standard are intended to apply to all products of a cannabis plant including those that can be classified as hemp and which contain cannabinoids and can be consumed/ingested via mouth, nose, skin (whether described as medicine, supplements, food, cosmetics, and so forth.).  
1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

  • Standard
    3 pages
    English language
    sale 15% off
ASTM
ASTM D8450-22(Specification)
Standard Specification for Environmental Conditions While Packaging Cannabis/Hemp Flower

SCOPE
1.1 This standard specifies the environmental conditions, such as temperature, humidity, and lighting, under which cannabis/hemp flowers intended for human use are to be packaged to ensure the safety, quality, and weight stabilization of the packaged flower. This specification does not apply to frozen cannabis/hemp nor to cannabis/hemp intended for extraction.  
1.2 This specification applies only to controlling an indoor environment (heat, cooling, humidity control) surrounding packaging operations. Outdoor operations are outside the scope of this specification and are not addressed.  
1.3 This specification is to be followed by licensed operators in the cannabis/hemp space who move the cured crop(s) into consumer or non-consumer packaging used for distribution.  
1.4 Security of the cannabis/hemp flower during the packaging process is not within the scope of this specification.  
1.5 This specification is intended to remain valid until the packaged cannabis/hemp flower is placed in storage or transit.  
1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

  • Technical specification
    3 pages
    English language
    sale 15% off
ASTM
ASTM D8441/D8441M-22(Specification)
Standard Specification for International Symbol for Identifying Consumer Products Containing Intoxicating Cannabinoids

SCOPE
1.1 This specification establishes an international symbol applicable to all products containing intoxicating cannabinoids at a quantity or concentration sufficient to have a warning deemed necessary by the authority having jurisdiction (AHJ).  
1.2 This specification shall apply to all finished products that are intended for consumer use, which includes topical use, ingestion, inhalation, and any/all other methods of adsorption on or in the body of a human or animal.  
1.3 This specification provides uniformity in identifying potential health and safety hazards associated with exposure to a substance that may cause intoxicating (that is, mind or consciousness altering, or both) effects.  
1.4 This specification seeks to ensure visual clarity and consistency, which results in improvement of recognition and comprehension for the end user.  
1.5 Units—The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system are not necessarily exact equivalents; therefore, to ensure conformance with the standard, each system shall be used independently of the other, and values from the two systems shall not be combined.  
1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

  • Technical specification
    4 pages
    English language
    sale 15% off
ASTM
ASTM E3336-22(Test Method)
Standard Test Method for Physical Integrity Testing of Single-Use Systems

SIGNIFICANCE AND USE
4.1 The test methods outlined in this standard allow for suppliers and end users of SUSs in (bio)pharmaceutical manufacturing processes to detect a leak and/or confirm the barrier properties of empty, clean, and dry SUSs. Performing integrity testing can be a significant contribution to the overall integrity assurance of SUSs.  
4.2 The two types of physical test methods outlined in this standard are:  
4.2.1 Section 5, Pressure-Based Test Methods.  
4.2.2 Section 6, Tracer Gas-Based Test Methods.
Note 3: Other test methods are currently being adapted for robust, reliable, and reproducible testing SUS, for example, Vacuum Decay Test Method as described in Test Method F2338.  
4.3 Pressure-based test methods are generally less sensitive compared to tracer gas-based test methods but have a lower complexity and cost. To assist in selecting a method that will fit an application, refer to Table 1 in Practice E3244 for a more detailed comparison of the two methods.  
4.4 Both types of test methods can be used to detect leaks of any sizes in a SUS (referred to as leak testing) or confirm the barrier properties of the SUS (referred to as integrity testing).  
4.5 To ensure that integrity testing performed on SUSs is effective and accurate, the properties of the SUS (pressure capabilities, volume, material properties, etc.) must be considered. Also, a validation should be performed on the chosen test method as further described in 5.11 and 6.11.  
4.6 Practice E3244 should be referenced to determine the maximum allowable leakage limit for a SUS, along with the routine testing requirements that are suitable for each application.  
4.7 The purpose of the described test methods is not to stress the SUS until a potential defect occurs. The testing parameters, mainly test pressure, are independent from the use-case conditions. The robustness of the SUS under use-case conditions should be proven during product qualification.  
4.8 This standard test method describes the...
SCOPE
1.1 The test methods described in this standard are applicable for single-use manufacturing equipment, further called Single-use Systems (SUSs), used for (bio)pharmaceutical products.  
1.2 The test methods described in this standard are not intended to be used on single-use technology for primary containers, combination products (products composed of any combination of a drug, device, or biological product), or devices. Appropriate procedures related to these products are discussed in documents covering the integrity assurance for primary containers (1)2 or medical products (2-4).  
1.3 The test methods and their validation are described to only cover testing of empty and dry SUSs. Residual liquid in the SUS can impact the test reliability and reproducibility.  
1.4 The test methods are intended to be used to confirm the barrier properties of the test article, further called integrity testing, or test the SUS for leaks of certain sizes, further called leak testing.
Note 1: To verify that an integrity test can confirm the intended barrier properties of the SUS, its detection limit must be equal or better than the respective maximum allowable leakage limit.  
1.5 The physical test methods covered by this standard are:  
1.5.1 Pressure-based test methods.  
1.5.2 Tracer gas-based test methods.  
1.6 The physical test methods described are in general non-destructive and allow further use of the SUS.
Note 2: Some variations can be used in a destructive way, for example, to perform root cause analysis of the leak.  
1.7 The standard describes the test apparatuses, operation procedures, environment requirements, and discusses specific challenges with testing SUSs, as well as how to perform robust validation of the test method.  
1.8 This standard does not include methods to determine the maximum allowable leakage limit for maintaining the barrier properties of the SUS. For that, refer to Practice E3244 and Test Me...

  • Standard
    15 pages
    English language
    sale 15% off
ASTM
ASTM F2559/F2559M-21(Guide)
Standard Guide for Writing a Specification for Sterilizable Peel Pouches

SIGNIFICANCE AND USE
5.1 Medical device peel pouches are universally used by the industry and produced by a myriad of suppliers. They may be constructed of many different materials including films, foils, paper, nonwovens such as Tyvek, and combinations thereof. However, even with the diversity of materials, there are still basic requirements that all pouches should exhibit. Above all, the pouches must contain and protect the device while maintaining sterility during all physical handling.  
5.2 Pouch requirements may be divided into two categories, initial pouch and material qualification, and routine production and receipt requirements to ensure the purchaser receives exactly what is ordered. While all requirements should be included in the written specification, initial qualification tests may only be needed prior to the first order. Routine production and receipt requirements should be adhered to on every order. Initial qualification requirements are indicated within each clause, where applicable.  
5.3 This guide provides an understanding of the requirements needed for the manufacture, purchase, and acceptance of a preformed peelable pouch. Appropriate test methods for compliance are also cited.
Note 1: All test methods for a particular requirement may not be cited due to specific or unique circumstances. For additional guidance on applicable methods, refer to Guide F2097.  
5.4 The specification and its requirements should be mutually agreed to by the supplier and purchaser of pouches. This helps ensure that pouches will comply to specified requirements.  
5.5 Standards such as ISO 11607-1 and ISO 11607-2 have established criteria for consideration in material testing and for validation. This guide supports the expectations of appropriate materials and package testing occurring within a system of validations supporting demonstration of compliance to ISO 11607-1 and ISO 11607-2.
SCOPE
1.1 This guide defines the requirements and considerations for flexible peel pouches with one open, unsealed end that are intended to be sterilized containing medical devices. These are also known as preformed sterile barrier systems.  
1.2 Pouch styles are categorized as chevron, header, and corner peel. These pouches are typically manufactured by heat sealing, or in some cases, by cohesive cold sealing. The sealing bond is intended to be peeled open to aseptically dispense the contents.  
1.3 Pouch materials may be either porous, nonporous, or any combination of the two.  
1.4 This guide addresses some critical printing requirements on the pouch.  
1.5 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the standard.  
1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

  • Guide
    6 pages
    English language
    sale 15% off
  • Guide
    6 pages
    English language
    sale 15% off
ASTM
ASTM D8400-21(Guide)
Standard Guide for Assessing Spoilage of Hemp Seed Intended for Human Consumption

SIGNIFICANCE AND USE
3.1 This guide provides a method for rapid, visual, on-site assessment of spoilage of hemp seed that will assist in managing food quality and productivity while maintaining consumer safety. It can be augmented with a number of laboratory tests to determine spoilage.  
3.2 This guide provides a method to identify hemp seed samples that are likely to spoil by quantifying discolored (dark yellow or brown) dehulled seed. Samples from lots/batches that display more than 2 % discolored2 dehulled seed are generally considered to be compromised.  
3.3 Laboratories providing certificates of analysis can validate this spoilage test. Used in conjunction with a peroxide value (PV) and FFA content or other methods, results will help determine the acceptability of a lot/batch of seed. In addition, a trained panel can complete organoleptic testing, but this should be used in combination with other tests.  
3.3.1 It is recommended that where possible, test results taken from samples are reported with a calculated margin of error to ensure statistical significance or relevant results.  
3.4 Product wastage will be reduced when spoilage is identified early, and decisions to re-target other viable uses may help assess pricing, discounts, and salvageable seed.
SCOPE
1.1 This guide covers the recommended steps for a visual assessment of spoilage in hemp seed intended for human consumption. Additional recognized laboratory tests can be completed as necessary to augment this guide.  
1.2 This guide applies to plant breeders, hemp seed producers, storage facilities, laboratories, and processors. This guide does not apply to hemp seed intended for planting.  
1.3 Units—The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

  • Guide
    4 pages
    English language
    sale 15% off
ASTM
ASTM D8343/D8343M-21(Practice)
Standard Practice for Measuring the Physical Properties of Cannabis/Hemp Pre-rolls

SIGNIFICANCE AND USE
4.1 This practice will specify the baseline physical properties of a pre-roll, including the weight of cannabis herbal material in the pre-roll, the length of the pre-roll, and the diameter of the pre-roll.  
4.2 This practice will provide clarity on the physical properties of cannabis pre-rolls.
SCOPE
1.1 This practice is intended to be used to identify the physical properties of a cannabis/hemp pre-roll.  
1.2 This practice shall apply to pre-rolls made using herbal material(s) from any type of a cannabis plant (that is, cannabis/hemp), regardless of the cannabinoid content. For the sake of brevity, the term “cannabis” shall be used henceforth to refer to any type of cannabis plant (cannabis/hemp).  
1.3 This practice helps to provide clarity on pre-roll preparation and sampling to identify, measure, and report the length, diameter, and weight of cannabis pre-rolls.  
1.4 This practice shall not be applicable to infused cannabis pre-rolls, which are outside the scope of this standard.  
1.5 Units—The values stated in either SI units or United States Customary Units (USC Units) are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the standard. Metric units will be stated as standard and USC units will be shown in brackets relative to the metric units.  
1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

  • Standard
    4 pages
    English language
    sale 15% off
SIST
SIST EN ISO 22413:2021(Main)
Transfer sets for pharmaceutical preparations - Requirements and test methods (ISO 22413:2021)
EN ISO 22413:2021

This document specifies requirements and test methods for sterilized single-use transfer sets that are used for pharmaceutical preparations.

  • Standard
    23 pages
    English language
    e-Library read for
    1 day
ASTM
ASTM D8222-21a(Guide)
Standard Guide for Establishing a Quality Management System (QMS) for Consumer Use of Cannabis/Hemp Products

SIGNIFICANCE AND USE
5.1 Effective decision-making in a quality systems-controlled environment comes from an informed understanding of quality issues and associated risks. As such, management should monitor and review the performance of the QMS at pre-planned and regular intervals to ensure the system’s effectiveness and identify opportunities for improvement of the QMS itself. Management should also provide oversight of the QMS by an independent quality practitioner(s) to assure its effectiveness.  
5.2 Moreover, risk-based decision-making encompasses all elements of the QMS and should be at the forefront of each decision. Consumer safety is the top priority, regardless of other considerations.  
5.3 Aspects of risk should be considered relative to intended (or unintended) uses of a product to ensure consumer safety. Management should assign priorities and adequate resources to activities or actions based on assessing the risk, including the probability of harm and the potential severity of that harm. It is essential to engage appropriate parties in evaluating the risk. Such parties may include:  
5.3.1 Consumers;  
5.3.2 Manufacturing personnel;  
5.3.3 Marketing personnel; and  
5.3.4 Other stakeholders, as needed.  
5.4 Implementation of risk management includes assessing the risks, implementing risk management controls commensurate with the level of risk, and evaluating the risk management efforts’ results. Risk management assessment is an iterative process and continues when additional information emerges that changes the potential risk’s nature.  
5.5 Risk management works in conjunction with process understanding to manage and control change and helps drive continuous improvement.
SCOPE
1.1 This guide focuses on the core elements of an effective quality management system (QMS) necessary to optimize consumer and product safety, product quality, and conformance with requirements from industry, governmental agencies, and other authorities having jurisdiction. This guide incorporates basic quality principles, guidelines, and industry best practices necessary to establish a QMS adaptable to all organizations.  
1.2 Laws and regulations from authorities having jurisdiction supersede recommendations within this guide.  
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

  • Guide
    7 pages
    English language
    sale 15% off
  • Guide
    7 pages
    English language
    sale 15% off
ASTM
ASTM E3250-21(Practice)
Standard Practice for Product Temperature and Equipment Pressure Instrumentation in Pharmaceutical Freeze Drying

SIGNIFICANCE AND USE
3.1 This practice deals with recommended best practices for freeze dryer instrumentation, particularly which is used for monitoring the status of the product during freeze drying and perhaps for equipment capability testing. Temperature and pressure are both critical variables affecting heat transfer, mass transfer, process efficiency, and product quality. For this reason, particular emphasis is placed on product temperature and pressure measurement within the freeze dryer. The methods discussed in this guide are limited to techniques that are equally applicable at both laboratory and production scale.  
3.2 Finally, it is recognized that “best practice” changes over time as new technology matures and process understanding deepens.
SCOPE
1.1 Recommended best practices in monitoring of product status during pharmaceutical freeze drying are presented focusing on methods that apply to both laboratory and production scale.  
1.2 With respect to product temperature measurement, sources of uncertainty associated with any type of measurement probe are discussed, as well as important differences between the two most common types of temperature-measuring instruments ― thermocouples and resistance temperature detectors (RTD). Two types of pressure transducers are discussed ― thermal conductivity type gauges and capacitance manometers, with the Pirani gauge being the thermal conductivity type gauge of choice. It is recommended that both types of pressure gauge be used on both the product chamber and the condenser for freeze dryers with an external condenser, and the reasoning for this recommendation is discussed.  
1.3 Aseptic filling and sterilization practices are outside the scope of this practice. These are recommendations to assist users in selecting best practices and they are not intended to supersede or replace regulatory requirements.  
1.4 Units—The values stated in SI units are to be regarded as the standard. No other units of measurement are included in this standard with the exception of mTorr for pressure measurement  
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

  • Standard
    12 pages
    English language
    sale 15% off
CEN
EN ISO 21976:2020(Main)
Packaging - Tamper verification features for medicinal product packaging (ISO 21976:2018)
SIST EN ISO 21976:2020

This document specifies requirements and provides guidance for the application, use and check of tamper verification features to the packaging of medicinal products.

  • Standard
    25 pages
    English language
    e-Library read for
    1 day
SIST
SIST EN ISO 21976:2020(Main)
Packaging - Tamper verification features for medicinal product packaging (ISO 21976:2018)
EN ISO 21976:2020

This document specifies requirements and provides guidance for the application, use and check of tamper verification features to the packaging of medicinal products.

  • Standard
    25 pages
    English language
    e-Library read for
    1 day
ASTM
ASTM D8334/D8334M-20(Practice)
Standard Practice for Sampling of Cannabis/Hemp Post-Harvest Batches for Laboratory Analyses

SIGNIFICANCE AND USE
5.1 This standard will provide best practices for the sampling of harvested cannabis inflorescence with the intent to assure representative sampling.  
5.2 The laboratory results and their respective harvest batch associations have implications and significance to regulatory requirements, quality control considerations throughout the product’s life cycle, and the safety of the consumers who may be adversely affected by consumption of product that was not tested in a homogeneous manner (3).  
5.3 This standard does not address the appropriate sampling of processed cannabis materials such as such as extracts, seeds, edibles, topicals, etc.  
5.4 This standard addresses the sampling of cannabis inflorescence destined for human or animal consumption.  
5.5 This standard does not address pre-harvest field sampling or large untrimmed or unprocessed harvest batches.
SCOPE
1.1 Cannabis harvested materials require sampling strategies throughout their life cycle, from cultivation to the end consumer. For purposes of this standard, the term cannabis is inclusive of all cannabis inflorescence, including hemp varieties. The qualitative and quantitative characteristics of cannabis/hemp for human or animal consumption has safety implications throughout the life cycle from cultivation to end consumer. This standard provides best practice procedures and protocols for sampling batches of harvested cannabis inflorescence. Cannabis/hemp materials often exhibit variability across different parts within the same plant or across different plants within the same cultivar, or both, (1, 2).2 Thus, sampling strategies are required which yield a representative a sample across a harvest batch. Representative sampling is required to ensure that the qualitative and quantitative test results accurately reflect cannabinoid identification, potency, identification and concentration of terpenes, concentration of trace metals, microbiological activity, mycotoxins, and concentration of pesticides across the batch.  
1.2 Where procedural aspects of this practice differ from local regulatory or jurisdictional requirements, the local regulatory or jurisdictional authority’s directives shall take precedence.  
1.3 Units—The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system are not necessarily exact equivalents; therefore, to ensure conformance with the standard, each system shall be used independently of the other, and values from the two systems shall not be combined.  
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

  • Standard
    7 pages
    English language
    sale 15% off
ASTM
ASTM E2500-20(Guide)
Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment

SIGNIFICANCE AND USE
5.1 Application of the approach described within this guide is intended to satisfy international regulatory expectations in ensuring that manufacturing systems and equipment are fit for intended use, for example, qualified, and to satisfy requirements for design, installation, operation, and performance.  
5.2 The approach described in this guide applies concepts and principles introduced in the FDA initiative, Pharmaceutical cGMPs for the 21st Century — A Risk-Based Approach.  
5.3 This guide supports, and is consistent with, the framework described in ICH Q8, ICH Q9, ICH Q10, and ICH Q11.  
5.4 This guide is designed to conform with FDA, EU, and other international regulations regarding equipment and facility suitability for use and qualification.  
5.5 This guide may be used independently or in conjunction with other Committee E55 standards published by ASTM International.
SCOPE
1.1 This guide is applicable to all elements of pharmaceutical and biopharmaceutical manufacturing systems including: good manufacturing practice (GMP) utility equipment, process equipment, supporting utilities, associated process monitoring and control systems, and automation systems that have the potential to affect product quality and patient safety.  
1.2 For brevity, these are referred to throughout the rest of this guide as manufacturing systems.  
1.3 This guide may also be applied to laboratory, information, and medical device manufacturing systems.  
1.4 This guide is applicable to both new and existing manufacturing systems. The approach may be used for implementation of changes to existing systems.  
1.5 This guide is applicable throughout the life-cycle of the manufacturing system from concept to retirement.  
1.6 This standard does not address employee health and safety, environmental, or other non-GxP regulations. This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

  • Guide
    6 pages
    English language
    sale 15% off
  • Guide
    6 pages
    English language
    sale 15% off
ASTM
ASTM E2898-20a(Guide)
Standard Guide for Risk-Based Validation of Analytical Methods for PAT Applications

SIGNIFICANCE AND USE
4.1 This guide supports the principles of Guide E2500 and extends these principles to validation of analytical methods for PAT applications. The ongoing process of method validation is graphically represented in Fig. 1, which shows the life cycle of the validation of analytical methods for PAT applications. Prerequisites for validation are the identification of the measurement requirements and development of a method to meet those requirements.  
FIG. 1 Life Cycle for the Validation of Analytical Method for PAT Applications  
4.2 The method risk assessment also takes into account the stage in the product life cycle at which the measurements are being made and how the resulting data will be used. The integration of these considerations in the risk assessment facilitates the determination of the level of validation necessary to ensure that the method is fit for purpose.  
4.3 Changes may occur during the product life cycle necessitating identification of changes to the measurement requirements and method update and revalidation. Procedures should be established to evaluate the continued suitability of the process analytical method and to make appropriate recommendations to update the process analytical method for the intended use during the product life cycle.  
4.4 Additional informative examples can be found in Practices D3764, D6122, E1655, E1790, E2056, E2617, and E2656; and Guide E2891 that address validation of methods and models. Other useful standards include ASME BPE2019, ISO 14971, ISO 15839, and USP Acoustic Emission .
SCOPE
1.1 This guide provides an overview to the risk-based validation of process analytical methods under a process analytical technology (PAT) paradigm for pharmaceuticals and biopharmaceuticals and as such includes guidance on assessing risk to product quality from inappropriate method validation.  
1.2 This guide builds on existing standards on the topic of validation concentrating on applying such standards to analytical methods for on-line analysis. In particular, it addresses the validation of at-line, on-line, or in-line PAT measurements and covers both drug substance and drug product (DP) measurements.  
1.3 The definitions of International Council for Harmonisation (ICH) validation parameters (such as specificity, precision, repeatability, etc.) apply; however, the method of demonstrating the validation parameters may vary from that described in ICH and is discussed.  
1.4 As consistent with the U.S. Food and Drug Administration (FDA) process validation guidance, this document also briefly covers ongoing assurance that the method remains in a validated state during routine use.  
1.5 Equipment and instrument qualification are out of the scope of this guide but will be referenced as inputs to validation of analytical methods for PAT applications.  
1.6 The validation of multivariate prediction models is out of scope but will be referenced as inputs to validation of analytical methods for PAT applications.  
1.6.1 The validation of any analytical model used in the PAT method is essential to the validation of the PAT method but, the details of the model validation process is out of scope. See term  model validation, 3.1.7.  
1.7 Microbiological methods are out of scope.  
1.8 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.9 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

  • Guide
    7 pages
    English language
    sale 15% off
  • Guide
    7 pages
    English language
    sale 15% off
ASTM
ASTM D8220-20(Guide)
Standard Guide for Conducting Recall/Removal Procedures for Products in the Cannabis Industry

SIGNIFICANCE AND USE
4.1 In this guide, steps are suggested for the effective development, control, and management of procedures and records required for an effective product recall/removal from the marketplace.  
4.2 This guide presents a systematic approach to procedures and documentation regarding the steps necessary to be taken in the event of a product recall or removal from the marketplace because of health, safety, or quality nonconformances.  
4.3 This guide provides a procedural basis for conducting a mock recall for purposes of evaluating the efficacy of an organization’s existing traceability systems.
SCOPE
1.1 This guide describes the general best-practices action plan for conducting product recall and removal/withdrawal as related to any incident requiring the recovery of cannabis-derived products. This guide applies to all cannabis-derived products commercially manufactured and distributed for consumer use. This guide is for suppliers, consumers, retailers, and distributors. A specific product recall decision is the result of unacceptable product safety and requires notification of the appropriate governmental agencies governing the entity’s product safety laws. Governing regulatory agencies expect a product to be recalled if it is deemed to be unsafe, misbranded, or adulterated. These governing agencies are referenced as regulatory agencies throughout this guide. Various jurisdictional regulatory agencies may have specific and additional recall requirements falling beyond the recommendations of this guide. In these cases, the requirements of the governing regulatory agency must be followed. This document also provides general guidelines for the removal/withdrawal of products from the marketplace. Product removal/withdrawal is undertaken for purely commercial reasons that are typically unrelated to product safety and does not require regulatory agency notification. Product removal/withdrawal is carried out in the same manner as a product recall. This guide is being published as a best-practices approach and does not replace absolute jurisdictional regulatory requirements.  
1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

  • Guide
    5 pages
    English language
    sale 15% off
ASTM
ASTM E2503-13(2020)(Practice)
Standard Practice for Qualification of Basket and Paddle Dissolution Apparatus

SIGNIFICANCE AND USE
2.1 This practice outlines a procedure for the mechanical calibration of paddle and basket dissolution units to ensure reproducibility of results.  
2.2 Once a unit meets all of the mechanical specifications included in this practice, it is considered calibrated and further calibration with dissolution calibrator tablets is not required.
SCOPE
1.1 This practice covers the set-up and calibration of the paddle and basket dissolution apparatus.  
1.2 Use of this practice may be applied to apparatus that have been modified to enable automatic dissolution testing (that is, a valve in the bottom of the vessel or sampling through the shaft).  
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

  • Standard
    4 pages
    English language
    sale 15% off
ASTM
ASTM E3230-20(Practice)
Standard Practice for Extraction of Particulate Matter from the Surfaces of Single-Use Components and Assemblies Designed for Use in Biopharmaceutical Manufacturing

SIGNIFICANCE AND USE
4.1 Conventional stainless-steel process equipment for biopharmaceutical manufacturing require cleaning and sterilization prior to implementation. Single-use systems (SUS), stand-alone equipment typically composed of plastic components and assemblies, are usually assembled in cleanrooms and are usually not cleaned or rinsed prior to implementation (with the exception of filters, which are often rinsed prior to use). SUS cleanliness with respect to particulate matter depends upon the quality of the SUS manufacturing process, and also upon the care and handling of the SUS upon implementation by the end-user.  
4.2 In the process of manufacturing single-use components or assemblies, particulate matter may adhere to the interior (fluid contacting) or exterior surfaces of SUS (BPSA). Visual inspection of SUS components and assemblies for particulate matter is often limited by translucent or opaque materials which inhibit visualization, especially of interior fluid-contacting surfaces. Also in some cases, the large size of single-use assemblies significantly reduces the effectiveness of visual inspections. A more complete assessment of particulate matter load requires a method to extract particulate matter from the surfaces of single-use components or assemblies using a test liquid, which makes the particles readily available for analytical characterization using counting, sizing and chemical/physical identification methods.  
4.3 Pharmaceutical manufacturers use a wide variety of configurations and sizes of single-use components and assemblies, such as bioreactors, bioprocess containers, tubing, connectors, clamps, valves, sensors and filters. Extraction of particulate matter may be relatively easy from small components with readily accessible surfaces, however, extraction of particulate matter from large and complex assemblies with less readily accessible interior surfaces may require significantly more effort.  
4.4 The wide variety of single-use components and asse...
SCOPE
1.1 This practice describes the requirements for development, qualification, and routine application of a procedure for the effective liquid extraction of particulate matter from the surfaces of single-use components and assemblies designed for use in biopharmaceutical manufacturing processes. The extraction generates a suspension of particulate matter in liquid which makes the particulate matter readily available for analytical characterization.  
1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

  • Standard
    12 pages
    English language
    sale 15% off
ASTM
ASTM D8217-20(Guide)
Standard Guide for Access Control System

SIGNIFICANCE AND USE
3.1 Access control system devices are installed at strategic locations, such as all exterior entrances, administrative offices, grow rooms, processing rooms, manufacturing rooms, storage areas, transaction areas, loading dock, vaults, and locker room.  
3.2 Access control system software tracks staff by recording access point ingress and egress activities while at the same time enhances the overall safety of the property.  
3.3 An access control system is especially important during an emergency to determine who is on and off the property.  
3.4 Individuals are permitted access after they have been subjected to background screening and issued credentials that allow for real-time monitoring and forensic analysis of employee or vendor on-site movement.  
3.5 All doors should also be secured with electric strike or magnetic locks that remain locked in the event of power loss (default secured).  
3.6 Limited access area door locks, unlocks, and opens through the use of a two-factor authentication consisting of at least two of the following: an access control credential (for example, badge, FOB, wireless device), personal identification number (PIN), or biometric, or combinations thereof with a keyed override system installed.  
3.7 Exterior door locks should be unlocked and opened through the use of a two-factor authentication consisting of at least two of the following: an access control credential (for example, badge, FOB, wireless device), personal identification number (PIN), or biometric, or combinations thereof with a keyed override system installed.  
3.8 Restricted access area, such as a vault and safe are protected by three-factor authentication consisting of at least three of the following: an access control credential (for example, badge, FOB, wireless device), personal identification number (PIN), or biometric, or combinations thereof.  
3.9 Growing, processing, manufacturing, transaction, product, and currency rooms should be protected by a minimum ...
SCOPE
1.1 This guide covers the recommended access control system for protecting resin cannabis, resin cannabis products, resin cannabis waste, currency, people, property, and assets.  
1.2 Units—The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard.  
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. The recommendations herein are offered as the minimum requirement. All standards are subject to the requirements of the local Authority Having Jurisdiction (AHJ) in any given area.  
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

  • Guide
    4 pages
    English language
    sale 15% off
ASTM
ASTM D8205-20(Guide)
Standard Guide for Video Surveillance System

SIGNIFICANCE AND USE
3.1 The video surveillance system safeguards various areas considered critical to operations. The surveillance system uses cameras capable of capturing images and videos that can be compressed, stored, or sent over communication networks. The main difference between a digital video surveillance system and an analog video surveillance system is that a digital video surveillance system is capable of capturing and storing the video signal in a digital format. A digital video surveillance solution can be managed from anywhere and provide interoperability. The cameras can be networked and footage encrypted and digitally archived, which is considered crucial for most resin cannabis businesses because the video feed can be secured and shared with government authorities.
SCOPE
1.1 This guide covers the recommended video surveillance system for protecting resin cannabis, resin cannabis products, resin cannabis waste, currency, people, property, and assets.  
1.2 Units—The values stated in inch-pound units are to be regarded as the standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard.  
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations as defined by the Authority Having Jurisdiction (AHJ) prior to use.  
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

  • Guide
    3 pages
    English language
    sale 15% off
ASTM
ASTM F2312-11(2020)(Terminology)
Standard Terminology Relating to Tissue Engineered Medical Products

SIGNIFICANCE AND USE
3.1 The need for standards regarding TEMPs has also prompted a need for definitions. This terminology sets forth definitions of the most commonly used terms and specifies the relationship among the sciences and components applied in tissue engineering to develop TEMPs. Use of these terms and an understanding of these relationships will unify the ASTM TEMPs standards with a common language such that the users of these standards can understand and interpret the standards more precisely. Terms specific to a TEMP standard will also be defined within the respective standard as appropriate.  
3.2 Defining Terms—Terms are defined with a broad scope to encompass these new products known as TEMPs. For instance, the definition for somatic cell therapy as stated in the “Guidance for Human Somatic Cell Therapy and Gene Therapy” (1)3 is recognized in this terminology. However, for the purposes of TEMPs that contain cells, we have added the definition of “cell” which is much broader and not limited to the use of living cells.  
3.3 Clinical Effects of TEMPs—The users of this terminology should note that terms used regarding the clinical effects of TEMPs, for instance, “modify or modification” of the patient's condition, may also be interpreted to “enhance, augment, transform, alter, improve, or supplement.” Similarly, “repair” may also serve to mean “restore.”  
3.4 The diagram in Fig. 1 shows the relationships of components of TEMPs and of the fields of science (for example, technologies and principles) used in tissue engineering to create TEMPs. Certain TEMPs may be tissue engineered or produced in vitro by using specific components and sciences to create an off-the-shelf TEMP for the users. Other TEMPs may by design require the users to place the components inside the patient, (that is, in vivo) to rely upon the patient's regenerative potential to achieve the product's primary intended purpose. The expectation of a TEMP used for therapeutic clinical applications is to have ...
SCOPE
1.1 This terminology defines basic terms and presents the relationships of the scientific fields related to Tissue Engineered Medical Products (TEMPs). Committee F04 has defined these terms for the specific purpose of unifying the language used in standards for TEMPs.  
1.2 The terms and relationships defined here are limited to TEMPs. They do not apply to any medical products of human origin regulated by the U.S. Food and Drug Administration under 21 CFR Parts 16 and 1270 and 21 CFR Parts 207, 807, and 1271.  
1.3 The terms and nomenclature presented in this standard are for the specific purposes of unifying the language used in TEMP standards and are not intended for labeling of regulated medical products.  
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

  • Standard
    9 pages
    English language
    sale 15% off
ASTM
ASTM D8218-20(Guide)
Standard Guide for Intrusion Detection System (IDS)

SIGNIFICANCE AND USE
3.1 The intrusion detection system (IDS) safeguards various areas considered critical to operations. Intrusion detection devices include but are not limited to, door or window contact alarms that are activated when the device is separated, such as opening; and motion detection technology that uses a passive infrared to survey the area and sounds an audible notification alarm when a person or object moves into the protected space. Also included are glass-break detectors that use an audio sensor to pick up the actual frequency of broken glass. If the glass-break detector “hears” broken glass, an alarm is activated. If any of the devices are triggered when the system is armed, an alert is sent to a 24-h monitoring area for notification.
SCOPE
1.1 This guide covers the recommended intrusion detection system (IDS) for protecting resin cannabis, resin cannabis products, resin cannabis waste, currency, people, property, and assets.  
1.2 Units—The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard.  
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

  • Guide
    3 pages
    English language
    sale 15% off
ASTM
ASTM F2475-20(Guide)
Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials

SIGNIFICANCE AND USE
5.1 The compatibility of packaging materials with a medical device is a requirement of many regulatory bodies. Since most medical devices are used or implanted in, around, or on the human body, the benefits of these devices must outweigh the risks. Therefore, the packaging materials that come in contact with the medical device must also be evaluated and determined to be safe for use with the human body in that they have no negative impact on the physical, chemical, or biological properties of the device. This evaluation may include both a study of relevant experience with, and actual testing of, packaging materials. Such an evaluation may result in the conclusion that no testing is needed if the material has a demonstrable history of safe use in the specific role that is the same as that of the package under design.  
5.2 The medical device manufacturer determines the need for appropriate testing, with consideration of the device/package interactions, if any. When screening information is needed regarding the biocompatibility of the packaging, cytotoxicity testing from the supplier is typically performed.
SCOPE
1.1 This guide provides information to determine the appropriate testing for biocompatibility of medical device packaging materials that have the potential to contact the patient directly or indirectly.  
1.2 This guide does not apply to secondary or tertiary packaging materials.  
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

  • Guide
    3 pages
    English language
    sale 15% off
  • Guide
    3 pages
    English language
    sale 15% off
ASTM
ASTM D8286-19(Guide)
Standard Guide for Processing Cannabis Product Complaints

SIGNIFICANCE AND USE
3.1 A product complaints program is an essential part of the organization’s Quality Management System. The ability to document, investigate, and correct issues related to product complaints provides manufacturers with opportunities for improvement. Putting in place appropriate corrective and preventive actions can lead to increased customer satisfaction, product safety, and increased market share.  
3.2 Requirements of regulatory bodies or governmental departments supersede the recommendations in this guide.
SCOPE
1.1 This guide is applicable to organizations engaged in the cultivation, processing, testing, packaging and labeling, storage, distribution, or transportation of cannabis products intended for human and animal consumption, including those derived from hemp. This guide describes the minimum requirements for maintaining a product complaint system for finished cannabis products and ensures that all complaints are received, processed, investigated, documented, and appropriate corrective and preventive actions are implemented in a timely manner.  
1.2 This guide applies to all cannabis-derived products commercially manufactured and distributed for consumer use.  
1.3 Units—The values stated in SI units are to be regarded as the standard. No other units of measurement are included in this standard.  
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

  • Guide
    2 pages
    English language
    sale 15% off
ASTM
ASTM D8282-19(Practice)
Standard Practice for Laboratory Test Method Validation and Method Development

SIGNIFICANCE AND USE
4.1 The demonstration that a method of analysis is fit for its intended purpose and application is done through method characterization and validation.  
4.2 Resulting SOPs should be reproducible under the same conditions by a different analyst working in a different laboratory.  
4.3 Test methods are designed to assess one or more of the following product attributes: identity, strength or concentration, quality, and purity.  
4.4 The steps of this practice contain the basic procedures for performing a TMC, a TMV, and a TMT. It is not imperative that each procedural step be followed in the designated order, but the ordered sequence is a logical progression of the steps for performing a TMC, a TMV, and a TMT.
SCOPE
1.1 The quality, efficacy, and safety of cannabis and products containing cannabis extracts shall be evaluated by validated testing methodologies used by trained staffed utilizing qualified instruments and/or materials.  
1.2 This practice provides the cannabis industry with guidance for the development and validation of testing methods that adequately evaluate cannabis and products containing cannabis extracts for quality, efficacy, and consumer health safety in the absence of validated methods from agencies. This includes, but is not limited to, the potency of active substances and adulteration, including impurities stemming from potential adulteration during agricultural or manufacturing processes or both (for example, pesticides, residual solvents, and the presence of fungus and microorganisms) before product approval and release for use. Depending on the methodology and precision and accuracy required, these methods may be both qualitative or quantitative.  
1.3 This practice shall define the procedures for test method characterization (TMC), test method validation (TMV), and test method transfer/transfer of analytical procedures (TMT/TAP) of biological, chemical spectroscopic, and physical-based laboratory test methods.  
1.4 Depending on the nature of the test in question (chemical, microbiological, etc.) different variables will need to be considered for validation. The particular variables subject to consideration are beyond the scope of this document. Refer to Guide E2857 for more guidance.  
1.5 This standard does not consider the specifics of acceptable test method limits and users should consult relevant standard literature to determine the appropriate test parameters.  
1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

  • Standard
    9 pages
    English language
    sale 15% off
ASTM
ASTM D8229-19(Guide)
Standard Guide for Corrective Action and Preventive Action (CAPA) for the Cannabis Industry

SIGNIFICANCE AND USE
3.1 The ability to identify and respond to opportunities before issues become systemic or are a risk to consumer health and safety is vital to maintaining compliance and achieving consumer expectations. The CAPA process is a systematic approach for documenting, identifying, and correcting existing and potential quality issues from various data sources. The CAPA subsystem analyzes and trends data inputs from quality systems and processes to identify if a quality issue is recurring, systemic in nature, or impacts consumer health and safety (see Fig. 1).
FIG. 1 CAPA Process versus CAPA Subsystem
SCOPE
1.1 This guide applies to all entities that cultivate, process, manufacture, test, and distribute cannabis products.  
1.2 This guide defines corrective action and preventive action (CAPA) and the significance of an effective CAPA process and CAPA subsystem.  
1.3 This guide defines instruction on the establishment of adequate processes and procedures for the identification, analysis, measurement, and correction of quality issues.  
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

  • Guide
    8 pages
    English language
    sale 15% off
ASTM
ASTM D8250-19(Practice)
Standard Practice for Applying a Hazard Analysis Critical Control Points (HACCP) System for Cannabis Consumable Products

SIGNIFICANCE AND USE
5.1 This practice provides general guidelines for the development and implementation of a HACCP system for operations that manufacture cannabis consumable products to prevent, control, or minimize hazards (biological, chemical, or physical) to an acceptable level. A HACCP system can prevent consumer harm when implemented and followed correctly.
SCOPE
1.1 This practice addresses the principles to follow when implementing and managing a Hazard Analysis Critical Control Point (HACCP) system for cannabis consumable products. This practice is not intended for cannabis industrial products (e.g., hemp products).  
1.2 Units—The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

  • Standard
    7 pages
    English language
    sale 15% off
ASTM
ASTM D8233-19(Guide)
Standard Guide for Packaging and Labeling of Consumer Resin Cannabis Products for Sale to Adult Consumers, Legally Authorized Medical Users, and Caregivers in a Business-to-Consumer Retail Environment (Retailers)

SIGNIFICANCE AND USE
4.1 This guide provides manufacturers, wholesalers, and retailers with guidance on how to package and label consumer resin cannabis products, based on their intended use, in a manner that prevents contamination and promotes prevention of accidental or improper consumption. The guide recommends packaging types, terminology, nomenclature, graphics, and symbols that enable consumers to determine product type, strain, potency, concentration, dosage, and expiration date, such that informed decisions can be made.
SCOPE
1.1 This guide is for the packaging and labeling of cannabis flowers, resins, and preparations derived therefrom for sale to adult consumers, legally authorized medical users, and caregivers in a business-to-consumer/patient/caregiver retail environment and other legal distribution channels. This includes labeling of products, regardless of packaging format, that will be purchased by adults in retail dispensaries, pharmacies, or other distribution methods (for example, postal shipment).  
1.2 This guide does not address packaging or labeling specific to non-consumer-facing transactions (for example, products packaged for transfer between business entities, including growers, processors, manufacturers, wholesalers, and retailers).  
1.3 This guide incorporates relevant materials previously published in other industry resources such as ASTM Committees D10 and F02, Foundation of Cannabis Unified Standards (FOCUS), American Herbal Products Association (AHPA), Occupational Safety and Health Administration (OSHA), and various sanctioned working group findings and publications (for example, Council on Responsible Cannabis Regulation (CRCR), National Cannabis Industry Association (NCIA), and so forth).  
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

  • Guide
    8 pages
    English language
    sale 15% off
ISO
ISO 21976:2018(Main)
Packaging - Tamper verification features for medicinal product packaging

This document specifies requirements and provides guidance for the application, use and check of tamper verification features to the packaging of medicinal products.

  • Standard
    16 pages
    English language
    sale 15% off
  • Standard
    17 pages
    French language
    sale 15% off
50