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ASTM E2898-14

(Guide)

Standard Guide for Risk-Based Validation of Analytical Methods for PAT Applications

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.  
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.  
4.4 Additional informative examples can be found in Practices D3764, D6122, E1655, E1790, E2056, E2617, and E2656 that address validation of methods and models. Other useful standards include ASME BPE2009, 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 API and Drug Product (DP) measurements.  
1.3 The definitions of International Conference on Harmonization (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.  
1.7 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 and health practices and determine the applicability of regulatory limitations prior to use.

General Information

Status
Historical
Publication Date
31-May-2014
ICS
11.120.99 - Other standards related to pharmaceutics
Technical Committee
E55 - Manufacture of Pharmaceutical and Biopharmaceutical Products
Drafting Committee
E55.01 - Process Understanding and PAT System Management, Implementation and Practice
Current Stage
Ref Project

Relations

Replaces
ASTM E2898-13 - Standard Guide for Risk-Based Validation of Analytical Methods for PAT Applications
Effective Date
01-Jun-2014
Replaced By
ASTM E2898-20 - Standard Guide for Risk-Based Validation of Analytical Methods for PAT Applications
Effective Date
15-May-2020
Referred By
ASTM E2629-20 - Standard Guide for Verification of Process Analytical Technology (PAT) Enabled Control Systems
Effective Date
01-Jun-2014
Referred By
ASTM E2968-23 - Standard Guide for Application of Continuous Manufacturing (CM) in the Pharmaceutical Industry
Effective Date
01-Jun-2014
Referred By
ASTM E3326-22 - Standard Guide for Application of Continuous Manufacturing (BioCM) in the Biopharmaceutical Industry
Effective Date
01-Jun-2014

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Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: E2898 − 14
Standard Guide for
Risk-Based Validation of Analytical Methods for PAT
1
Applications
This standard is issued under the fixed designation E2898; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope 2. Referenced Documents
2
2.1 ASTM Standards:
1.1 This guide provides an overview to the risk-based
validation of process analytical methods under a process D3764 Practice forValidation of the Performance of Process
Stream Analyzer Systems
analytical technology (PAT) paradigm for pharmaceuticals and
biopharmaceuticalsandassuchincludesguidanceonassessing D6122 Practice for Validation of the Performance of Multi-
variate Online,At-Line, and Laboratory Infrared Spectro-
risk to product quality from inappropriate method validation.
photometer Based Analyzer Systems
1.2 This guide builds on existing standards on the topic of
E1655 Practices for Infrared Multivariate Quantitative
validation concentrating on applying such standards to analyti-
Analysis
cal methods for on-line analysis. In particular, it addresses the
E1790 Practice for Near Infrared Qualitative Analysis
validation of at-line, on-line, or in-line PAT measurements and
E2056 Practice for Qualifying Spectrometers and Spectro-
covers both API and Drug Product (DP) measurements.
photometers for Use in Multivariate Analyses, Calibrated
1.3 The definitions of International Conference on Harmo-
Using Surrogate Mixtures
nization (ICH) validation parameters (such as specificity,
E2476 Guide for Risk Assessment and Risk Control as it
precision, repeatability, etc.) apply; however, the method of
Impacts the Design, Development, and Operation of PAT
demonstrating the validation parameters may vary from that
Processes for Pharmaceutical Manufacture
described in ICH and is discussed.
E2500 Guide for Specification, Design, and Verification of
Pharmaceutical and Biopharmaceutical Manufacturing
1.4 As consistent with the U.S. Food and DrugAdministra-
Systems and Equipment
tion (FDA) process validation guidance, this document also
E2617 Practice for Validation of Empirically Derived Mul-
briefly covers ongoing assurance that the method remains in a
tivariate Calibrations
validated state during routine use.
E2629 Guide for Verification of ProcessAnalytical Technol-
1.5 Equipment and instrument qualification are out of the
ogy (PAT) Enabled Control Systems
scope of this guide but will be referenced as inputs to
E2656 PracticeforReal-timeReleaseTestingofPharmaceu-
validation of analytical methods for PAT applications.
tical Water for the Total Organic Carbon Attribute
1.6 The validation of multivariate prediction models is out 3
2.2 ICH Standards:
of scope but will be referenced as inputs to validation of
Q2(R1) Guidance on Validation of Analytical Procedures:
analytical methods for PAT applications.
Text and Methodology
Q7 Good Manufacturing Practice Guide for Active Pharma-
1.7 Microbiological methods are out of scope.
ceutical Ingredients
1.8 This standard does not purport to address all of the
Q9 Quality Risk
safety concerns, if any, associated with its use. It is the
ICH Quality Implementation Working Group Points to
responsibility of the user of this standard to establish appro-
Consider (R2) ICH-Endorsed Guide for ICH Q8/Q9/Q10
priate safety and health practices and determine the applica-
Implementation dated 6 December 2011
bility of regulatory limitations prior to use.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
1
This guide is under the jurisdiction of ASTM Committee E55 on Manufacture contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
ofPharmaceuticalandBiopharmaceuticalProductsandisthedirectresponsibilityof Standards volume information, refer to the standard’s Document Summary page on
Subcommittee E55.01 on Process Understanding and PAT System Management, the ASTM website.
3
Implementation and Practice. Available from International Conference on Harmonisation of Technical
Current edition approved June 1, 2014. Published June 2014. Originally Requirements for Registration of Pharmaceuticals for Human Use (ICH), ICH
approved in 2013. Last previous edition approved in 2013 as E2898 – 13. DOI: Secretariat, c/o IFPMA, 15 ch. Louis-Dunant, P.O. Box 195, 1211 Geneva 20,
10.1520/E2898-14. Switzerland, http://www.ich.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
E2898 − 14
2.3 Other Standards: 3.1.10.1 Discussion—Qualification is part of validation, but
4
ASM
...

This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: E2898 − 13 E2898 − 14
Standard Guide for
Risk-Based Validation of Analytical Methods for PAT
1
Applications
This standard is issued under the fixed designation E2898; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. 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 API and Drug Product (DP) measurements.
1.3 The definitions of International Conference on Harmonization (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.
1.7 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 and health practices and determine the applicability of regulatory
limitations prior to use.
2. Referenced Documents
2
2.1 ASTM Standards:
D3764 Practice for Validation of the Performance of Process Stream Analyzer Systems
D6122 Practice for Validation of the Performance of Multivariate Online, At-Line, and Laboratory Infrared Spectrophotometer
Based Analyzer Systems
E1655 Practices for Infrared Multivariate Quantitative Analysis
E1790 Practice for Near Infrared Qualitative Analysis
E2056 Practice for Qualifying Spectrometers and Spectrophotometers for Use in Multivariate Analyses, Calibrated Using
Surrogate Mixtures
E2476 Guide for Risk Assessment and Risk Control as it Impacts the Design, Development, and Operation of PAT Processes
for Pharmaceutical Manufacture
E2500 Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and
Equipment
1
This guide is under the jurisdiction of ASTM Committee E55 on Manufacture of Pharmaceutical Products and is the direct responsibility of Subcommittee E55.01 on
PAT System Management, Implementation and Practice.
Current edition approved Nov. 1, 2013June 1, 2014. Published December 2013June 2014. Originally approved in 2013. Last previous edition approved in 2013 as E2898
– 13. DOI: 10.1520/E2898-13.10.1520/E2898-14.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
E2898 − 14
E2617 Practice for Validation of Empirically Derived Multivariate Calibrations
E2629 Guide for Verification of Process Analytical Technology (PAT) Enabled Control Systems
E2656 Practice for Real-time Release Testing of Pharmaceutical Water for the Total Organic Carbon Attribute
3
2.2 ICH Standards:
Q2(R1) Guidance on Validation of Analytical Procedures: Text and Methodology
Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
Q9 Quality Risk
ICH Quality Implementation Working Group Points to Consider (R2) ICH-Endorsed Guide for ICH Q8/Q9/Q10 Implementation
dated 6 December 2011
2.3 Other Standards:
4
ASME BPE2009 BioProcessing Equ
...

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ASTM E3336-22(Test Method)
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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.  
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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.  
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1.2 This guide is applicable to the range of manufacturing systems described in Guide E2500, specifically all elements of single-use systems, or hybrids of single-use and traditional components, used for the manufacturing of pharmaceutical and biopharmaceutical products, including: materials of construction, components, assembly, manifolds, supporting utilities, associated process monitoring and control systems, automation systems, and controlled environment that have the potential to affect product quality and patient safety.  
1.3 This guide is applicable for the implementation of changes to manufacturing system design for existing systems. It may be used for continuous improvement and changes in operation from clinical through to commercial scale.  
1.4 For brevity, single-use systems are referred to as SUS throughout the rest of this guide.  
1.5 The approach may be applied by the end user, the supplier of SUS, and raw materials sub-suppliers further back in the supply chain.  
1.6 This guide is not intended to apply to the use of single-use technology for packaging, primary containers, combination products (products composed of any combination of a drug, device, or biological product) or devices.  
1.7 This guide does not address specific local requirements, which remain the responsibility of the end user.  
1.8 This guide does not address employee health and safety, environmental, nor other good engineering and manufacturing practices (GXP) requirements. 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 and health practices and determine the applicability of regulatory limitations prior to use.

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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.

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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...

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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.

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