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ASTM E2474-06

(Practice)

Standard Practice for Pharmaceutical Process Design Utilizing Process Analytical Technology

Standard Practice for Pharmaceutical Process Design Utilizing Process Analytical Technology

ABSTRACT
This practice covers pharmaceutical process design utilizing process analytical technology, which is integral to process development as well as post-development process optimization. It is focused on practical implementation and experimental development of process understanding. The principles in this practice are applicable to both drug substance and drug product processes. For drug products, formulation development and process development are interrelated and therefore the process design will incorporate knowledge from the formulation development. The following practices and methodologies shall be done to attain desired state: risk assessment and mitigation; continuous improvement; process fitness for purpose; intrinsic performance assessment; manufacturing strategy; data collection and formal experimental design; multivariate tools; process analyzers; and process control.
SCOPE
1.1 This practice covers process design, which is integral to process development as well as post-development process optimization. It is focused on practical implementation and experimental development of process understanding.
1.2 The term process design as used in this practice can mean:
1.2.1 The activities to design a process (the process design), and/or
1.2.2 The outcome of this activity (the designed process).
1.3 The principles in this practice are applicable to both drug substance and drug product processes. For drug products, formulation development and process development are interrelated and therefore the process design will incorporate knowledge from the formulation development.
1.4 The principles in this practice apply during development of a new process or the improvement or redesign of an existing one, or both.
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-Oct-2006
ICS
11.120.01 - Pharmaceutics in general
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

Replaced By
ASTM E2474-14 - Standard Practice for Pharmaceutical Process Design Utilizing Process Analytical Technology (Withdrawn 2020)
Effective Date
01-Apr-2014
Referred By
ASTM E2500-20 - Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
Effective Date
01-Nov-2006
Referred By
ASTM E2891-20 - Standard Guide for Multivariate Data Analysis in Pharmaceutical Development and Manufacturing Applications
Effective Date
01-Nov-2006
Referred By
ASTM E2475-10(2016) - Standard Guide for Process Understanding Related to Pharmaceutical Manufacture and Control
Effective Date
01-Nov-2006

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ASTM E2474-06 - Standard Practice for Pharmaceutical Process Design Utilizing Process Analytical TechnologyASTM E2474-06 - Standard Practice for Pharmaceutical Process Design Utilizing Process Analytical Technology
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ASTM E2474-06 - Standard Practice for Pharmaceutical Process Design Utilizing Process Analytical Technology
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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: E2474 − 06
StandardPractice for
Pharmaceutical Process Design Utilizing Process Analytical
Technology
This standard is issued under the fixed designation E2474; 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.
INTRODUCTION
Process design is the systematic conversion of information about needs for a product into
knowledge about how to manufacture this product. Products and manufacturing processes should be
designed using science- and risk-based design strategies to manage variation.
To attain this goal, integration of Process Analytical Technology (PAT) principles and tools during
process design will enhance opportunities to build, maintain, and expand science- and risk-based
process understanding throughout a product lifecycle. The product lifecycle includes the period in
production as well as development.
Process understanding will be the foundation to establish manufacturing (process selection,
methodology, implementation, and practice), process control (real-time control on the basis of
measured critical quality attributes), effective risk mitigation, and product release concepts.
Process understanding will also enable regulatory strategies in that the level of regulatory scrutiny
may reflect the demonstrated level of science- and risk-based process understanding.
1. Scope responsibility of the user of this standard to establish appro-
priate safety and health practices and determine the applica-
1.1 This practice covers process design, which is integral to
bility of regulatory limitations prior to use.
process development as well as post-development process
optimization. It is focused on practical implementation and
2. Referenced Documents
experimental development of process understanding.
2.1 Referenced Standards:
1.2 The term process design as used in this practice can
FDA Guidance for Industry: PAT—A Framework for Inno-
mean:
vative Pharmaceutical Development, Manufacturing, and
1.2.1 The activities to design a process (the process design),
Quality Assurance, September 2004
and/or
ICH Guidance: ICH Q8 Pharmaceutical Development, Step
1.2.2 The outcome of this activity (the designed process).
4 Document, November 2005
1.3 The principles in this practice are applicable to both
ICH Guidance: ICH Q9 Quality Risk Management, Step 4
drug substance and drug product processes. For drug products,
Document, November 2005
formulation development and process development are inter-
related and therefore the process design will incorporate 3. PAT Process Design Practices
knowledge from the formulation development.
3.1 Desired State—In the desired state of a process, all
1.4 Theprinciplesinthispracticeapplyduringdevelopment
sources of variation are defined and controlled, and end
of a new process or the improvement or redesign of an existing product variation is minimal. That implies that critical product
one, or both. attributes are controlled to target for all individual units of a
product. As a result, processes are capable of consistently
1.5 This standard does not purport to address all of the
supplying, unit to unit and batch to batch, the desired quality.
safety concerns, if any, associated with its use. It is the
Available from Food and Drug Administration (FDA), 5600 Fishers Ln.,
This practice is under the jurisdiction of ASTM Committee E55 on Manufac- Rockville, MD 20857, http://www.fda.gov.
ture of Pharmaceutical Products and is the direct responsibility of Subcommittee Available from International Conference on Harmonisation of Technical
E55.01 on PAT System Management, Implementation and Practice. Requirements for Registration of Pharmaceuticals for Human Use (ICH), ICH
Current edition approved Nov. 1, 2006. Published November 2006. DOI: Secretariat, c/o IFPMA, 15 ch. Louis-Dunant, P.O. Box 195, 1211 Geneva 20,
10.1520/E2474-06. Switzerland, http://www.ich.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
E2474 − 06
Philosophy and Principles 3.5.2.1 Process steps (unit operations) are evaluated as
connected operations, because outputs are inputs for subse-
3.2 Practice #1: Risk Assessment and Mitigation—Products
quent steps.
and manufacturing processes should be designed to minimize
3.5.2.2 Measurements are focused on assessment(s) of criti-
variation. Therefore, process design is a means to mitigate the
cal quality attributes and/or factors associated with process
risk of having product units with varying quality. The process
condition rather than on documenting compliance.
designrequirestheuseofformalriskevaluationmethodologies
3.5.2.3 Measurements are discriminating (to account for the
and mitigation assessments.
multivariate process nature), rather than averaging (because
3.3 Practice #2: Continuous Improvement:
information is lost through averaging of data).
3.3.1 Process design starts with the identification of first
3.5.2.4 Process performance-based optimization reduces to-
design options that reflect the desired process state and the
tal variability (that is, input material, process, and analytical
desired product attributes.
variability).
3.3.2 Evaluation of the first and all following design options
3.5.2.5 Process measurements and controls are designed in.
should follow an iterative process of design improvement.
3.6 Practice #5: Manufacturing Strategy:
3.3.3 Design improvement is continued post-launch (con-
3.6.1 There is a mutual relationship between the develop-
tinuous improvement) to support management of process
ment of the manufacturing process and the risk mitigation
quality throughout the product lifecycle.
strategy for a given product, as the process is designed to
3.3.4 The iterative approach to continuous process design
delive
...

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1.1 The purpose of this guide is to establish a framework and context for process understanding for pharmaceutical manufacturing using the principles of quality by design (QbD) (Juran, 1992;2 ICH Q8). The framework is applicable to both drug substance (DS) and drug product (DP) manufacturing. High (detailed) level process understanding can be used to facilitate production of product which consistently meets required specifications. It can also play a key role in continual process improvement efforts.  
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1.1 This standard covers terminology used by the E55 Committee relating to pharmaceutical and biopharmaceutical industry for manufacture of pharmaceutical and biopharmaceutical products. Terms that are generally understood and in common usage or adequately defined in other readily available references are not included except where particular delineation to pharmaceutical and biopharmaceutical manufacturing may be more clearly stated.  
1.2 This terminology is, therefore, intended to be selective of terms used generally in the manufacture of pharmaceutical and biopharmaceutical products and published in a number of documents such as those listed in the succeeding section. The listing is also intended to define terms that appear prominently within other related ASTM International standards and do not appear elsewhere.  
1.3 The definitions are substantially identical to those published by regulatory agencies such as the U.S. Food and Drug Administration, European Medicines Agency, Pharmaceutical and Medical Devices Agency (Japan), other and national competent authorities (human) as well as other authoritative bodies, such as ICH, ISO, and national standards organizations.  
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SIGNIFICANCE AND USE
4.1 Although some CM is used in the pharmaceutical industry (for example, purified water production), and some processes are inherently continuous individual unit operations (such as dry granulation and compression), these operations are generally operated in isolation and do not deliver the potential benefits of an integrated CM operation. The FDA Guidance for Industry PAT document specifically identifies that the introduction of continuous processing (now redefined as CM) may be one of the outcomes from the adoption of a science-based approach to process design.  
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1.1 This guide introduces key concepts and principles to assist in the appropriate selection, development and operation of CM technologies for the manufacture of pharmaceutical products. Athough selected concepts covered here can be applied to biopharmaceutical CM (BioCM), the focus of this guide is on non-biopharmaceutical applications.  
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1.1 This guide covers the applications of multivariate data analysis (MVDA) to support pharmaceutical development and manufacturing activities. MVDA is one of the key enablers for process understanding and decision making in pharmaceutical development, and for the release of intermediate and final products after being validated appropriately using a science and risk-based approach.  
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4.1 Application of the approach described within this standard guide applies science-based concepts and principles introduced in the FDA’s initiative on pharmaceutical CGMPs for the 21st century.4  
4.2 This guide supports, and is consistent with, elements from ICH Q8 – Q11 and guidelines from USFDA, European Commission, Pharmaceutical Inspection Co-operation Scheme, and the China Food and Drug Administration.8  
4.3 According to FDA Guidance for Industry, PAT, “With real time quality assurance, the desired quality attributes are ensured through continuous assessment during manufacture. Data from production batches can serve to validate the process and reflect the total system design concept, essentially supporting validation with each manufacturing batch.” In other words, the accumulated product and process understanding used to identify the Critical Quality Attributes (CQAs), together with the control strategy, will enable control of the CQAs, providing the confidence needed to show validation with each batch. This is as opposed to a traditional discrete process validation approach.
SCOPE
1.1 This guide describes Continuous Process Verification as an alternate approach to process validation where manufacturing process (or supporting utility system) performance is continuously monitored, evaluated, and adjusted (as necessary). It is a science-based approach to verify that a process is capable and will consistently produce product meeting its predetermined critical quality attributes. Continuous Process Verification (ICH Q8) is similarly described as Continuous Quality Verification.  
1.2 Pharmaceutical and biopharmaceutical product manufacturing companies are required to provide assurance that the processes used to manufacture regulated products result in products with the specified critical quality attributes of strength identity and purity associated with the product safety and efficacy. Process validation is a way in which companies provide that assurance.  
1.3 With the knowledge obtained during the product lifecycle, a framework for continuous quality improvements will be established where the following may be possible: (1) risk identified, (2) risk mitigated, (3) process variability reduced, (4) process capability enhanced, (5) process design space defined or enhanced, and ultimately (6) product quality improved. This can enable a number of benefits that address both compliance and operational goals (for example, real time release, continuous process improvement).  
1.4 The principles in this guide may be applied to drug product or active pharmaceutical ingredient/drug substance pharmaceutical and biopharmaceutical batch or continuous manufacturing processes or supporting utility systems (for example, TOC for purified water and water for injection systems, and so forth).  
1.5 The principles in this guide may be applied during the development and manufacturing of a new process or product or for the improvement or redesign, or both, of an existing process.  
1.6 Continuous process verification may be applied to manufacturing processes that use monitoring systems that provide frequent and objective measurement of process data in real time. These processes may or may not employ in-, on-, or at-line analyzers/controllers that monitor, measure, analyze, and control the process performance. The associated processes may or may not have a design space.  
1.7 This guide may be used independently or in conjunction with other proposed E55 standards to be published by ASTM International.

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SIGNIFICANCE AND USE
5.1 These methods are intended to determine whether a material, product, or part of a product has the degree of radiopacity desired for its application as a medical device in the human body. This method allows for comparison with or without the use of a body mimic. Comparisons without the use of a body mimic should be used with caution as the relative radiopacity can be affected when imaging through the human body.  
5.2 These methods allow for both qualitative and quantitative evaluation in different comparative situations.
SCOPE
1.1 These test methods cover the determination of the radiopacity of materials and products utilizing X-ray based techniques, including fluoroscopy, angiography, CT (computed tomography), and DEXA (dual energy X-ray absorptiometry), also known as DXA, The results of these measurements are an indication of the likelihood of locating the product within the human body.  
1.2 Radiopacity is determined by (a) qualitatively comparing image(s) of a test specimen and a user-defined standard, with or without the use of a body mimic; or (b) quantitatively determining the specific difference in optical density or pixel intensity between the image of a test specimen and the image of a user-defined standard, with or without the use of a body mimic.  
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.

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ASTM
ASTM E2363-23(Terminology)
Standard Terminology Relating to Manufacturing of Pharmaceutical and Biopharmaceutical Products in the Pharmaceutical and Biopharmaceutical Industry

SCOPE
1.1 This standard covers terminology used by the E55 Committee relating to pharmaceutical and biopharmaceutical industry for manufacture of pharmaceutical and biopharmaceutical products. Terms that are generally understood and in common usage or adequately defined in other readily available references are not included except where particular delineation to pharmaceutical and biopharmaceutical manufacturing may be more clearly stated.  
1.2 This terminology is, therefore, intended to be selective of terms used generally in the manufacture of pharmaceutical and biopharmaceutical products and published in a number of documents such as those listed in the succeeding section. The listing is also intended to define terms that appear prominently within other related ASTM International standards and do not appear elsewhere.  
1.3 The definitions are substantially identical to those published by regulatory agencies such as the U.S. Food and Drug Administration, European Medicines Agency, Pharmaceutical and Medical Devices Agency (Japan), other and national competent authorities (human) as well as other authoritative bodies, such as ICH, ISO, and national standards organizations.  
1.4 This terminology supplements current documents on terminology that concentrate on the manufacture of pharmaceutical and biopharmaceutical products.  
1.5 An increasing number of product designations and designations for chemical, physical, mechanical, analytical, and statistical tests and standards are coming into common usage in the literature, regulatory environment, and commerce associated with the manufacture of pharmaceutical and biopharmaceutical products.  
1.6 Units—The values stated in SI units are to be regarded as the standard. No other units of measurement are included in this standard.  
1.7 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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