Glossary
Stability Testing
Also writtenstability studystability studies
Testing that evaluates how quality changes with time and with temperature, humidity, and light, in order to set the retest period, shelf life, and storage conditions.
Source · WHO Quality Assurance of Medicines Terminology Database, Stability studies; ICH Q1A(R2)
Related sections
21 CFR 211.160–211.194EU GMP Part I Chapter 6
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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In addition, you did not provide data demonstrating that adequate chemical and microbiological testing is performed on your drug products during stability testing.
FDA · FDA Warning Letter · 2024-05-07 -
You failed to establish an adequate stability testing program to support the labeled expiration date on your distributed drug products in the U.S.
FDA · FDA Warning Letter · 2026-06-09 -
You failed to establish a stability testing program to support the expiry of your distributed drug products.
FDA · FDA Warning Letter · 2025-04-29
Counted as of 2026-09-24 — the search you land on shows today's figures, so it may differ slightly.
Source
WHO Quality Assurance of Medicines Terminology Database, Stability studies; ICH Q1A(R2)GRM Regulatory Glossary
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