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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US (FDA) Compliance
Content current as of 20 September 2023
US (FDA) Compliance
Inspection Technical Guide (Initiated 18 October 1985, Contents current as of 07 November 2014)
US (FDA) Compliance
Pharmaceutical Quality Control Labs (7/93)
US (FDA) Compliance
Updated Routinely
US (FDA) CVM
Issued November 2020
US (FDA) ORAQ
Document Number MAN-000037. ORA Lab Manual Vol. II. Revised 31 Oct 2023
US (FDA) Quality
Final Guidance, issued January 2017. Draft was issued in January 2015.
US (FDA) Quality
Guidance for Industry and FDA Staff. January 2017 final guidance. The draft of this document was issued in January 2015.
US (FDA) Quality
Guidance for Industry, April 2022
US (FDA) Quality
Audits • Guidances • Quality • Regulatory
US (FDA) Quality
Guidance for Industry. Issued on June 29, 2020. The draft of this document was issued on March 29, 2019
US (FDA), CBER/CDER
Issued June 2021
US (USP) General Chapters
Revision / postponement Announcement-supersedes the monograph becoming official in USP 40–NF 35.
US (USP) Monographs
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