ASTM E2500-13

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, 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 may be used independently or in conjunction with other E55 standards published by ASTM International.
SCOPE
1.1 This guide is applicable to all elements of pharmaceutical and biopharmaceutical manufacturing systems including: facility 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 the implementation of changes to existing systems, and their continuous improvement during operation.  
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 and health practices and determine the applicability of regulatory limitations prior to use.

General Information

• Status: Historical
• Publication Date: 31-Oct-2013
• ICS: 11.120.99 - Other standards related to pharmaceutics
• Technical Committee: E55 - Manufacture of Pharmaceutical and Biopharmaceutical Products
• Drafting Committee: E55.03 - General Pharmaceutical Standards

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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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:E2500 −13
Standard Guide for
Specification, Design, and Verification of Pharmaceutical
and Biopharmaceutical Manufacturing Systems and
1
Equipment
This standard is issued under the fixed designation E2500; 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
Process Analytical Technology
1.1 This guide is applicable to all elements of pharmaceu-
E2475 Guide for Process Understanding Related to Pharma-
tical and biopharmaceutical manufacturing systems including:
ceutical Manufacture and Control
facility equipment, process equipment, supporting utilities,
E2476 Guide for Risk Assessment and Risk Control as it
associated process monitoring and control systems, and auto-
Impacts the Design, Development, and Operation of PAT
mation systems that have the potential to affect product quality
Processes for Pharmaceutical Manufacture
and patient safety.
E2537 Guide for Application of Continuous Quality Verifi-
1.2 For brevity, these are referred to throughout the rest of
cation to Pharmaceutical and Biopharmaceutical Manu-
this guide as manufacturing systems.
facturing
1.3 This guide may also be applied to laboratory, E2629 Guide for Verification of ProcessAnalytical Technol-
ogy (PAT) Enabled Control Systems
information, and medical device manufacturing systems.
1.4 This guide is applicable to both new and existing 2.2 Other Publications:
FDA Guidance for Industry Process Validation: General
manufacturing systems. The approach may be used for the
3
implementation of changes to existing systems, and their Principles and Practices
4
ICH Q8 Pharmaceutical Development
continuous improvement during operation.
4
ICH Q9 Quality Risk Management
1.5 This guide is applicable throughout the life-cycle of the
4
ICH Q10 Pharmaceutical Quality System
manufacturing system from concept to retirement.
ICHQ11 DevelopmentandManufactureofDrugSubstances
1.6 This standard does not address employee health and
(Chemical Entities and Biotechnological/Biological Enti-
safety, environmental, or other non-GxP regulations. This 4
ties)
standard does not purport to address all of the safety concerns,
Pharmaceutical cGMPs for the 21st Century —A Risk-
if any, associated with its use. It is the responsibility of the user 3
Based Approach
of this standard to establish appropriate safety and health
practices and determine the applicability of regulatory limita-
3. Terminology
tions prior to use.
3.1 Definitions—For definitions of terms used in this guide,
refer to Terminology E2363.
2. Referenced Documents
3.1.1 acceptance criteria—the criteria that a system or
2
2.1 ASTM Standards:
component must satisfy in order to be accepted by a user or
E2363 Terminology Relating to ProcessAnalytical Technol-
other authorized entity.
ogy in the Pharmaceutical Industry
3.1.2 design reviews—planned and systematic reviews of
specifications, design, and design development and continuous
improvement changes performed as appropriate throughout the
1
This guide is under the jurisdiction of ASTM Committee E55 on Manufacture
ofPharmaceuticalandBiopharmaceuticalProductsandisthedirectresponsibilityof
Subcommittee E55.03 on General Pharmaceutical Standards.
Current edition approved Nov. 1, 2013. Published November 2013. Originally
3
approved in 2007. Last previous edition approved in 2012 as E2500 – 07 (2012). Available from Food and Drug Administration (FDA), 5600 Fishers Ln.,
DOI: 10.1520/E2500-13. Rockville, MD 20857, http://www.fda.gov.
2 4
For referenced ASTM standards, visit the ASTM website, www.astm.org, or Available from International Conference on Harmonisation of Technical
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM Requirements for Registration of Pharmaceuticals for Human Use (ICH), ICH
Standards volume information, refer to the standard’s Document Summary page on Secretariat, c/o IFPMA, 15 ch. Louis-Dunant, P.O. Box 195, 1211 Geneva 20,
the ASTM website. Switzerland, http://www.ich.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

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E2500−13
life-cycle of the manufacturing system. Design reviews evalu- 5.3 This guide supports, and is consistent with, the frame-
ate deliverables against standards and requirements, identify work described in ICH Q8, ICH Q9, ICH Q10, and ICH Q11.
problems, and propose required corrective actions.
5.4 This guide may be used independently or in conjunction
3.1.3 manufacturing systems—elements of ph
...

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: E2500 − 07 (Reapproved 2012) E2500 − 13
Standard Guide for
Specification, Design, and Verification of Pharmaceutical
and Biopharmaceutical Manufacturing Systems and
1
Equipment
This standard is issued under the fixed designation E2500; 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 is applicable to all elements of pharmaceutical and biopharmaceutical manufacturing systems including: facility
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 the implementation
of changes to existing systems, and their continuous improvement during operation.
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 and health practices and determine the applicability of regulatory limitations prior to use.
2. Referenced Documents
2
2.1 ASTM Standards:
E2363 Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry
E2474 Practice for Pharmaceutical Process Design Utilizing Process Analytical Technology
E2475 Guide for Process Understanding Related to Pharmaceutical Manufacture and Control
E2476 Guide for Risk Assessment and Risk Control as it Impacts the Design, Development, and Operation of PAT Processes
for Pharmaceutical Manufacture
E2537 Guide for Application of Continuous Quality Verification to Pharmaceutical and Biopharmaceutical Manufacturing
E2629 Guide for Verification of Process Analytical Technology (PAT) Enabled Control Systems
1
This guide is under the jurisdiction of ASTM Committee E55 on Manufacture of Pharmaceutical Products and is the direct responsibility of Subcommittee E55.03 on
General Pharmaceutical Standards.
Current edition approved Oct. 15, 2012Nov. 1, 2013. Published November 2012November 2013. Originally approved in 2007. Last previous edition approved in 20072012
as E2500 – 07. 07 (2012). DOI: 10.1520/E2500-07R12.10.1520/E2500-13.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at [e-mail]. 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 ----------------------
E2500 − 13
2.2 Other Publications:
3
FDA Guidance for Industry Process Validation: General Principles and Practices
4
ICH Q8 Pharmaceutical Development Handbook
4
ICH Q9 Quality Risk HandbookManagement
4
ICH Q10 Pharmaceutical Quality System
4
ICH Q11 Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities)
3
Pharmaceutical cGMPs for the 21st Century —A Risk-Based Approach
3. Terminology
3.1 Definitions—For definitions of terms used in this guide, refer to Terminology E2363.
3.1.1 acceptance criteria—the criteria that a system or component must satisfy in order to be accepted by a user or other
authorized entity.
3.1.2 design reviews—planned and systematic reviews of specifications, design, and design development and continuous
improvement changes performed as appropriate throughout the life-cycle of the manufacturing system. Design reviews evaluate
deliverables against standards and requirements, identify problems, and propose required corrective actions.
3.1.3 manufacturing systems—elements of pharmaceutical and biopharmaceutical manufacturing capability, including manu-
facturing systems, facility equipment, process equipment, supporting utilities, associated process monitor
...