Stability Regulations
This segment is a growing collection of laws, guidances and requirements pertaining to the stability function from various nations and recognized global and regional organizations. While some are legal requirements, others are guidances that can be fulfilled with justified alternative measures, but all are expectations of duly authorized regulatory bodies.
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Regulations by Regulatory Body
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International (ICH) Q
Current Step 4 version dated 10 March 1999
International (ICH) Q
Final version (R1) adopted on 18 January 2023
International (ICH) Q
Final version adopted on 18 January 2023
International (ICH) Q
International (ICH) Q
Presentation (dated 27 May 2022) on the Step 4 document – to be implemented
International (ICH) Q
Links to multiple training presentations
International (ICH) Q
Final Concept Paper endorsed by the ICH Steering Committee on 21 October 2014
International (IPEC)
First Version 2021
International (IPEC) Americas
International (IPEC) Europe
Copyright 2010
International (ISO) 21973
ISO/FDIS 21973
International (ISO) ISO 11607
This standard has been withdrawn
International (ISPE)
Published December 2021
International (ISPE) Quality
2nd edition, published June 2019
International (PIC/S) Annexes
International (PIC/S) REDICA Systems
International (WHO) Annex
International (WHO) Eastern Mediterranean
International (WHO) Technical Guidance Series
ISPE
Industry Association Best Practices
UK (MHRA) Inspectorate
This is an Inspectorate Blog (an introduction GDP Guide 3.2.1)
US (ASTM) Standards Products
ASTM F1980-21
US (ASTM) Standards Products
ASTM D4332-22
US (ASTM) Standards Products
ASTM F2097-23
US (CFR) 21 CFR 211.166
US (CHPA) Public Policy
Adopted June 24, 2009 (Consumer Healthcare Products Association (CHPA))
US (CLSI) Standards
Approved Guideline September 2009 (Clinical and Laboratory Standards Institute (CLSI))
US (FDA) CBER
Issued January 2020
US (FDA) CBER/CDER/CDRH/CVM
Issued February 2008
US (FDA) CDER
Issued June 2013
US (FDA) CDER
Issued May 2014
US (FDA) CDER
Issued July 2020
US (FDA) CDER
Issued May 2022
US (FDA) CDER
Issued October 2006 (Superseded by guidance issued May 2022)
US (FDA) CDER/CBER
Issued November 2022
US (FDA) CDER/CBER
Issued March 2023
US (FDA) CDER/CBER
Withdrawn Guidance from June 1998
US (FDA) Compliance
Content current as of 20 September 2023
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