Glossary

Stability Testing

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.

Related sections

21 CFR 211.160–211.194EU GMP Part I Chapter 6

Related terms

Expiry Date (Expiration Date)31 casesRetest Date15 casesOut-of-Trend (OOT) Result31 cases

Real inspection findings

Findings from regulators' inspection documents in which this term appears.

  1. 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
  2. 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
  3. You failed to establish a stability testing program to support the expiry of your distributed drug products.
    FDA · FDA Warning Letter · 2025-04-29
See 235 findings that mention this term

Source

WHO Quality Assurance of Medicines Terminology Database, Stability studies; ICH Q1A(R2)
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