ASTM E2629-19
(Guide)Standard Guide for Verification of Process Analytical Technology (PAT) Enabled Control Systems
Standard Guide for Verification of Process Analytical Technology (PAT) Enabled Control Systems
SIGNIFICANCE AND USE
5.1 This guide supports the principles of Guide E2500 and extends these principles to the verification of PAT-enabled control systems.
5.2 This guide clarifies what is important for verification of PAT-enabled control systems. Such systems are often complex and require multidisciplinary and cross-functional teams to achieve optimum results. This guide provides a common basis for understanding requirements for all involved disciplines such as control engineering, development, manufacturing, and process validation.
SCOPE
1.1 This guide describes the verification of process analytical technology (PAT) enabled control systems using a science- and risk-based approach. It establishes principles for determining the scope and extent of verification activities necessary to ensure that the PAT-enabled control system is fit for purpose, properly implemented, and functions as expected.
1.2 In this guide, a PAT-enabled control system is considered to be the system that adjusts the manufacturing process using timely measurements (that is, during processing) of attributes of raw and in-process materials to determine responses that assure the process remains within specified boundaries and minimizes variability in the output material. The overall aim of the PAT-enabled control system is to ensure product quality. The PAT-enabled control system of a manufacturing process provides the capability to determine the current status of the process and drive the process to ensure the output material has the desired quality characteristics. The control system should be able to respond to process variations in a timely manner, providing corrections that ensure that the process follows the desired process trajectory to reach the desired outcome. PAT-enabled control systems may use process models based on first principles understanding or empirical models derived from experimental investigations or both. In addition to automated controls, a PAT-enabled control system may include components where there is manual intervention.
1.3 Principles described in this guide may be applied regardless of the complexity or scale of the PAT-enabled control system or whether applied to batch or continuous processing, or both. The intention of this standard is to describe and support the implementation of a PAT enabled Control Strategy, as described in ICH Q8(R2).
1.4 The principles described in this guide are applicable to a PAT-enabled control system and also to its component subsystems. This guide does not cover the requirements for continuous quality verification of the overall process, which are covered in Guide E2537, or for validation of PAT methods, which is covered in Guide E2898.
1.5 For information on science- and risk-based approaches in the pharmaceutical industry, reference should be made to ICH Q8(R2), ICH Q9, and ICH Q10. For guidance on PAT systems in the pharmaceutical industry, reference should be made to FDA Guidance for Industry—PAT and FDA Guidance for Industry—Process Validation, as well as EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use and EU Guideline on Process Validation for Finished Products.
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.
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Designation:E2629 −19
Standard Guide for
Verification of Process Analytical Technology (PAT) Enabled
1
Control Systems
This standard is issued under the fixed designation E2629; 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 1.4 The principles described in this guide are applicable to
a PAT-enabled control system and also to its component
1.1 This guide describes the verification of process analyti-
subsystems. This guide does not cover the requirements for
cal technology (PAT) enabled control systems using a science-
continuous quality verification of the overall process, which
and risk-based approach. It establishes principles for determin-
are covered in Guide E2537, or for validation of PAT methods,
ing the scope and extent of verification activities necessary to
which is covered in Guide E2898.
ensure that the PAT-enabled control system is fit for purpose,
1.5 For information on science- and risk-based approaches
properly implemented, and functions as expected.
in the pharmaceutical industry, reference should be made to
1.2 In this guide, a PAT-enabled control system is consid-
ICH Q8(R2), ICH Q9, and ICH Q10. For guidance on PAT
ered to be the system that adjusts the manufacturing process
systems in the pharmaceutical industry, reference should be
using timely measurements (that is, during processing) of
made to FDA Guidance for Industry—PAT and FDA Guidance
attributes of raw and in-process materials to determine re-
for Industry—Process Validation, as well as EU Guidelines for
sponses that assure the process remains within specified
Good Manufacturing Practice for Medicinal Products for
boundaries and minimizes variability in the output material.
Human and Veterinary Use and EU Guideline on Process
The overall aim of the PAT-enabled control system is to ensure
Validation for Finished Products.
product quality. The PAT-enabled control system of a manu-
1.6 This standard does not purport to address all of the
facturing process provides the capability to determine the
safety concerns, if any, associated with its use. It is the
current status of the process and drive the process to ensure the
responsibility of the user of this standard to establish appro-
output material has the desired quality characteristics. The
priate safety, health, and environmental practices and deter-
control system should be able to respond to process variations
mine the applicability of regulatory limitations prior to use.
in a timely manner, providing corrections that ensure that the
1.7 This international standard was developed in accor-
process follows the desired process trajectory to reach the
dance with internationally recognized principles on standard-
desired outcome. PAT-enabled control systems may use pro-
ization established in the Decision on Principles for the
cess models based on first principles understanding or empiri-
Development of International Standards, Guides and Recom-
cal models derived from experimental investigations or both.
mendations issued by the World Trade Organization Technical
In addition to automated controls, a PAT-enabled control
Barriers to Trade (TBT) Committee.
system may include components where there is manual inter-
vention.
2. Referenced Documents
2
1.3 Principles described in this guide may be applied
2.1 ASTM Standards:
regardless of the complexity or scale of the PAT-enabled
E122 Practice for Calculating Sample Size to Estimate,With
control system or whether applied to batch or continuous
Specified Precision, the Average for a Characteristic of a
processing,orboth.Theintentionofthisstandardistodescribe
Lot or Process
and support the implementation of a PAT enabled Control
E2363 Terminology Relating to ProcessAnalytical Technol-
Strategy, as described in ICH Q8(R2).
ogy in the Pharmaceutical Industry
E2476 Guide for Risk Assessment and Risk Control as it
Impacts the Design, Development, and Operation of PAT
1
This guide is under the jurisdiction of ASTM Committee E55 on Manufacture
Processes for Pharmaceutical Manufacture
ofPharmaceuticalandBiopharmaceuticalProductsandisthedirectresponsibilityof
Subcommittee E55.01 on Process Understanding and PAT System Management,
2
Implementation and Practice. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Current edition approved June 15, 2019. Published July 2019. Originally contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
approved in 2011. Last previous edition approved in 2011 as E2629 – 11. DOI: Standards volume information, refer to the standard’s Document Summary page on
10.1520
...
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: E2629 − 11 E2629 − 19
Standard Guide for
Verification of Process Analytical Technology (PAT) Enabled
1
Control Systems
This standard is issued under the fixed designation E2629; 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 describes the verification of process analytical technology (PAT) enabled control systems using a science- and
risk-based approach. It establishes principles for determining the scope and extent of verification activities necessary to ensure that
the PAT-enabled control system is fit for purpose, properly implemented, and functions as expected.
1.2 In this guide, a PAT-enabled control system is considered to be the system that adjusts the manufacturing process using
timely measurements (that is, during processing) of attributes of raw and in-process materials to determine responses that assure
the process remains within specified boundaries and minimizes variability in the output material. The overall aim of the
PAT-enabled control system is to ensure product quality. The PAT-enabled control system of a manufacturing process provides the
capability to determine the current status of the process and drive the process to ensure the output material has the desired quality
characteristics. The control system should be able to respond to process variations in a timely manner, providing corrections that
ensure that the process follows the desired process trajectory to reach the desired outcome. PAT-enabled control systems may use
process models based on first principles understanding or empirical models derived from experimental investigations or both. In
addition to automated controls, a PAT-enabled control system may include components where there is manual intervention.
1.3 Principles described in this guide may be applied regardless of the complexity or scale of the PAT-enabled control system
or whether applied to batch or continuous processing, or both. The intention of this standard is to describe and support the
implementation of a PAT enabled Control Strategy, as described in ICH Q8(R2).
1.4 The principles described in this guide are applicable to a PAT-enabled control system and also to its component subsystems.
This guide does not cover the requirements for continuous quality verification of the overall process, which are covered in Guide
E2537, or for validation of PAT methods, which is covered in Guide E2898.
1.5 For information on science- and risk-based approaches in the pharmaceutical industry, reference should be made to
ICH Q8(R2), ICH Q9, and ICH Q10. For guidance on PAT systems in the pharmaceutical industry, reference should be made to
FDA Guidance for Industry—PAT and FDA Guidance for Industry—Process Validation.Validation, as well as EU Guidelines for
Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use and EU Guideline on Process Validation for
Finished Products.
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 safety, health, and healthenvironmental 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.
2. Referenced Documents
2
2.1 ASTM Standards:
E122 Practice for Calculating Sample Size to Estimate, With Specified Precision, the Average for a Characteristic of a Lot or
Process
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, 2011June 15, 2019. Published May 2011July 2019. Originally approved in 2011. Last previous edition approved in 2011 as E2629 –
11. DOI: 10.1520/E2629-11.10.1520/E2629-19.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at se
...
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