Glossary
Acceptance Criteria
Numerical limits, ranges, or other suitable measures that decide whether a test result is acceptable.
Source · ICH Q7, §20 Glossary, Acceptance Criteria; 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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According to your Process Qualification Reports (dated January 17, 2017, March 16, 2020, and April 7, 2023), you only required (b)(4) donors to meet your process qualification acceptance criteria even if some donor batches in the…
FDA · FDA Warning Letter · 2024-08-27 -
Your firm failed to establish acceptance criteria for the sampling and testing conducted by the quality control unit that are adequate to assure that batches of drug products meet appropriate statistical quality control criteria as a condition for their approval and release (21 CFR 211.165(d)).
FDA · FDA Warning Letter · 2025-12-02 -
You provided a protocol for cleaning the (b)(4) tank used to manufacture (b)(4) , which does not include acceptance criteria for carryover residues.
FDA · FDA Warning Letter · 2025-02-11
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, Acceptance Criteria; MFDS, 「알기 쉬운 GMP 용어집」 Korean originalGRM Regulatory Glossary
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