Glossary

Retest Date

The date on which an API must be re-examined to confirm it is still suitable for use.

Related sections

ICH Q7 §§10, 14–15 EU GMP Part I Chapter 4 EU GMP Part I Chapter 8

Related terms

Expiry Date (Expiration Date)31 casesStability Testing235 casesActive Pharmaceutical Ingredient (API) / Drug Substance85 cases

Real inspection findings

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

  1. You have inadequate stability data to support the (b)(4) retest date for (b)(4) .
    FDA · FDA Warning Letter · 2025-02-11
  2. You established the current, (b)(4) retest date for (b)(4) API by testing reserve samples from one batch (batch (b)(4) ).
    FDA · FDA Warning Letter · 2022-02-15
  3. For example, your firm does not have adequate data to support the retest date for drugs shipped to the United States.
    FDA · FDA Warning Letter · 2025-03-25
See 15 findings that mention this term

Source

ICH Q7, §20 Glossary, Retest Date
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