ASTM E2475-10(2016)
(Guide)Standard Guide for Process Understanding Related to Pharmaceutical Manufacture and Control
Standard Guide for Process Understanding Related to Pharmaceutical Manufacture and Control
SCOPE
1.1 The purpose of this guide is to establish a framework and context for process understanding for pharmaceutical manufacturing using quality by design (QbD) (Juran, 1992;2 FDA/ICH Q8). The framework is applicable to both active pharmaceutical ingredient (API) and to 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 continuous process improvement efforts.
1.2 Process Analytical Technology (PAT) is one element that can be used for achieving control over those inputs determined to be critical to a process. It is important for the reader to recognize that PAT is defined as:
“…a system for designing, analyzing, and controlling manufacturing through timely measurements (i.e., during processing) of critical quality and performance attributes of raw and in process materials and processes, with the goal of ensuring final product quality. It is important to note that the term analytical in PAT is viewed broadly to include chemical, physical, microbiological, mathematical, and risk analysis conducted in an integrated manner. The goal of PAT is to enhance understanding and control the manufacturing process…” (U.S. FDA PAT)
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 and health practices and determine the applicability of regulatory limitations prior to use.
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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.
Designation: E2475 − 10 (Reapproved 2016)
Standard Guide for
Process Understanding Related to Pharmaceutical
1
Manufacture and Control
This standard is issued under the fixed designation E2475; 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 E2474 Practice for Pharmaceutical Process Design Utilizing
4
Process Analytical Technology (Withdrawn 2020)
1.1 The purpose of this guide is to establish a framework
E2617 Practice for Validation of Empirically Derived Mul-
and context for process understanding for pharmaceutical
2 tivariate Calibrations
manufacturing using quality by design (QbD) (Juran, 1992;
5
2.2 U.S. Government Publications:
FDA/ICH Q8). The framework is applicable to both active
FDA/ICH Q8 Pharmaceutical Development
pharmaceutical ingredient (API) and to drug product (DP)
FDA/ICH Q10 Pharmaceutical Quality Systems
manufacturing. High (detailed) level process understanding
U.S. FDA PAT Guidance Document, Guidance for Industry
can be used to facilitate production of product which consis-
PAT—A Framework for Innovative Pharmaceutical
tently meets required specifications. It can also play a key role
Manufacturing and Quality Assurance
in continuous process improvement efforts.
3. Terminology
1.2 Process Analytical Technology (PAT) is one element
that can be used for achieving control over those inputs
3.1 Definitions of Terms Specific to This Standard:
determined to be critical to a process. It is important for the
3.1.1 critical inputs, n—critical process parameters and
reader to recognize that PAT is defined as:
critical raw material attributes for a given process.
6
“{a system for designing, analyzing, and controlling manufacturing through
American Society for Quality
timely measurements (i.e., during processing) of critical quality and performance
3.1.2 empirical, adj—any conclusion based on experimental
attributes of raw and in process materials and processes, with the goal of
ensuring final product quality. It is important to note that the term analytical in
data and past experience, rather than on theory.
PAT is viewed broadly to include chemical, physical, microbiological,
3.1.3 expert system, n—an expert system is a computer
mathematical, and risk analysis conducted in an integrated manner. The goal of
PAT is to enhance understanding and control the manufacturing process{”
program that simulates the judgment and behavior of a human
(U.S. FDA PAT)
or an organization that has expert knowledge and experience in
1.3 This standard does not purport to address all of the
a particular field.
safety concerns, if any, associated with its use. It is the
3.1.3.1 Discussion—Typically, such a system contains a
responsibility of the user of this standard to establish appro-
knowledge base containing accumulated experience and a set
priate safety and health practices and determine the applica-
of rules for applying the knowledge base to each particular
bility of regulatory limitations prior to use.
situation that is described to the program. Sophisticated expert
systems can be enhanced with additions to the knowledge base
2. Referenced Documents
or to the set of rules.
3
2.1 ASTM Standards:
3.1.4 first principles, n—a calculation is said to be from first
E456 Terminology Relating to Quality and Statistics
principles, or ab initio, if it starts directly at the level of
E2281 Practice for Process Capability and Performance
established laws of physics and does not make assumptions
Measurement
such as model and fitting parameters.
3.1.5 mechanistic, adj—(1) of, or relating to, theories that
1
This guide is under the jurisdiction of ASTM Committee E55 on Manufacture
explain phenomena in purely physical or deterministic terms: a
of Pharmaceutical and Biopharmaceutical Products and is the direct responsibility of
Subcommittee E55.11 on Process Design.
mechanistic interpretation of nature.
Current edition approved Sept. 1, 2016. Published September 2016. Originally
approved in 2010. Last previous edition approved in 2010 as E2475 – 10.
4
DOI:10.1520/E2475-10R16. The last approved version of this historical standard is referenced on
2
Juran, J., Juran on Quality by Design: The New Steps for Planning Quality Into www.astm.org.
5
Goods and Services, Free Press, New York, N.Y., 1992. Available from U.S. Government Printing Office Superintendent of Documents,
3
For referenced ASTM standards, visit the ASTM website, www.astm.org, or 732 N. Capitol St., NW, Ma
...
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: E2475 − 10 (Reapproved 2016)
Standard Guide for
Process Understanding Related to Pharmaceutical
1
Manufacture and Control
This standard is issued under the fixed designation E2475; 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 E2474 Practice for Pharmaceutical Process Design Utilizing
4
Process Analytical Technology (Withdrawn 2020)
1.1 The purpose of this guide is to establish a framework
E2617 Practice for Validation of Empirically Derived Mul-
and context for process understanding for pharmaceutical
2 tivariate Calibrations
manufacturing using quality by design (QbD) (Juran, 1992;
5
2.2 U.S. Government Publications:
FDA/ICH Q8). The framework is applicable to both active
FDA/ICH Q8 Pharmaceutical Development
pharmaceutical ingredient (API) and to drug product (DP)
FDA/ICH Q10 Pharmaceutical Quality Systems
manufacturing. High (detailed) level process understanding
U.S. FDA PAT Guidance Document, Guidance for Industry
can be used to facilitate production of product which consis-
PAT—A Framework for Innovative Pharmaceutical
tently meets required specifications. It can also play a key role
Manufacturing and Quality Assurance
in continuous process improvement efforts.
1.2 Process Analytical Technology (PAT) is one element 3. Terminology
that can be used for achieving control over those inputs
3.1 Definitions of Terms Specific to This Standard:
determined to be critical to a process. It is important for the
3.1.1 critical inputs, n—critical process parameters and
reader to recognize that PAT is defined as:
critical raw material attributes for a given process.
6
“{a system for designing, analyzing, and controlling manufacturing through
American Society for Quality
timely measurements (i.e., during processing) of critical quality and performance
3.1.2 empirical, adj—any conclusion based on experimental
attributes of raw and in process materials and processes, with the goal of
ensuring final product quality. It is important to note that the term analytical in
data and past experience, rather than on theory.
PAT is viewed broadly to include chemical, physical, microbiological,
3.1.3 expert system, n—an expert system is a computer
mathematical, and risk analysis conducted in an integrated manner. The goal of
PAT is to enhance understanding and control the manufacturing process{”
program that simulates the judgment and behavior of a human
(U.S. FDA PAT)
or an organization that has expert knowledge and experience in
1.3 This standard does not purport to address all of the
a particular field.
safety concerns, if any, associated with its use. It is the
3.1.3.1 Discussion—Typically, such a system contains a
responsibility of the user of this standard to establish appro-
knowledge base containing accumulated experience and a set
priate safety and health practices and determine the applica-
of rules for applying the knowledge base to each particular
bility of regulatory limitations prior to use.
situation that is described to the program. Sophisticated expert
systems can be enhanced with additions to the knowledge base
2. Referenced Documents
or to the set of rules.
3
2.1 ASTM Standards:
3.1.4 first principles, n—a calculation is said to be from first
E456 Terminology Relating to Quality and Statistics
principles, or ab initio, if it starts directly at the level of
E2281 Practice for Process Capability and Performance
established laws of physics and does not make assumptions
Measurement
such as model and fitting parameters.
3.1.5 mechanistic, adj—(1) of, or relating to, theories that
1
This guide is under the jurisdiction of ASTM Committee E55 on Manufacture
explain phenomena in purely physical or deterministic terms: a
of Pharmaceutical and Biopharmaceutical Products and is the direct responsibility of
Subcommittee E55.11 on Process Design.
mechanistic interpretation of nature.
Current edition approved Sept. 1, 2016. Published September 2016. Originally
approved in 2010. Last previous edition approved in 2010 as E2475 – 10.
4
DOI:10.1520/E2475-10R16. The last approved version of this historical standard is referenced on
2
Juran, J., Juran on Quality by Design: The New Steps for Planning Quality Into www.astm.org.
5
Goods and Services, Free Press, New York, N.Y., 1992. Available from U.S. Government Printing Office Superintendent of Documents,
3
For referenced ASTM standards, visit the ASTM website, www.astm.org, or 732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401, http://
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM www.access.gpo.gov.
6
Standa
...
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: E2475 − 10 E2475 − 10 (Reapproved 2016)
Standard Guide for
Process Understanding Related to Pharmaceutical
1
Manufacture and Control
This standard is issued under the fixed designation E2475; 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 The purpose of this guide is to establish a framework and context for process understanding for pharmaceutical
2
manufacturing using quality by design (QbD) (Juran, 1992; FDA/ICH Q8). The framework is applicable to both active
pharmaceutical ingredient (API) and to 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 continuous process
improvement efforts.
1.2 Process Analytical Technology (PAT) is one element that can be used for achieving control over those inputs determined
to be critical to a process. It is important for the reader to recognize that PAT is defined as:
“{a system for designing, analyzing, and controlling manufacturing through timely measurements (i.e., during processing)
of critical quality and performance attributes of raw and in process materials and processes, with the goal of ensuring final
product quality. It is important to note that the term analytical in PAT is viewed broadly to include chemical, physical,
microbiological, mathematical, and risk analysis conducted in an integrated manner. The goal of PAT is to enhance
understanding and control the manufacturing process{” (U.S. FDA PAT)
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 and health practices and determine the applicability of regulatory
limitations prior to use.
2. Referenced Documents
3
2.1 ASTM Standards:
E456 Terminology Relating to Quality and Statistics
E2281 Practice for Process Capability and Performance Measurement
E2474 Practice for Pharmaceutical Process Design Utilizing Process Analytical Technology
E2617 Practice for Validation of Empirically Derived Multivariate Calibrations
4
2.2 U.S. Government Publications:
FDA/ICH Q8 Pharmaceutical Development
FDA/ICH Q10 Pharmaceutical Quality Systems
U.S. FDA PAT Guidance Document, Guidance for Industry PAT—A Framework for Innovative Pharmaceutical Manufacturing
and Quality Assurance
3. Terminology
3.1 Definitions of Terms Specific to This Standard:
3.1.1 critical inputs, n—critical process parameters and critical raw material attributes for a given process.
5
American Society for Quality
3.1.2 empirical, adj—any conclusion based on experimental data and past experience, rather than on theory.
1
This guide is under the jurisdiction of ASTM Committee E55 on Manufacture of Pharmaceutical and Biopharmaceutical Products and is the direct responsibility of
Subcommittee E55.01 on Process Understanding and PAT System Management, Implementation and Practice.
Current edition approved April 15, 2010Sept. 1, 2016. Published August 2010September 2016. DOI:10.1520/E2475-10.Originally approved in 2010. Last previous edition
approved in 2010 as E2475 – 10. DOI:10.1520/E2475-10R16.
2
Juran, J., Juran on Quality by Design: The New Steps for Planning Quality Into Goods and Services, Free Press, New York, N.Y., 1992.
3
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.
4
Available from U.S. Government Printing Office Superintendent of Documents, 732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401, http://
www.access.gpo.gov.
5
Available from American Society for Quality (ASQ), 600 N. Plankinton Ave., Milwaukee, WI 53203, http://www.asq.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
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E2475 − 10 (2016)
3.1.3 expert system, n—an expert system is a computer program that simulates the judgment and behavior of a human or an
organization that has expert knowledge and experience in a particular field.
3.1.3.1 Discussion—
Typically, su
...
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