Glossary
Expiry Date (Expiration Date)
The date after which the material may not be used, being the date up to which it is expected to remain within specification under the stated storage conditions.
Source · ICH Q7, §20 Glossary, Expiry Date; MFDS, 「알기 쉬운 GMP 용어집」 Korean original
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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Failure to design a documented, ongoing stability testing program to monitor the stability characteristics of API and to use the results to confirm appropriate storage conditions and retest or expiry dates.
FDA · FDA Warning Letter · 2026-05-19 -
For example, you assigned a (b)(4) expiry date to your drug products…
FDA · FDA Warning Letter · 2025-06-03 -
Failure to design a documented, ongoing stability testing program to monitor the stability characteristics of APIs and to use the results to confirm the appropriate storage conditions and the retest or expiry dates.
FDA · FDA Warning Letter · 2026-08-18
Counted as of 2026-09-24 — the search you land on shows today's figures, so it may differ slightly.
Source
ICH Q7, §20 Glossary, Expiry Date; MFDS, 「알기 쉬운 GMP 용어집」 Korean originalGRM Regulatory Glossary
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