Glossary
Impurity
Any component of an API or a finished product that is not the intended active ingredient or excipient.
Source · MFDS, 「알기 쉬운 GMP 용어집」, Impurity Korean original
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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Specifically, you failed to perform microbial testing and impurity…
FDA · FDA Warning Letter · 2023-02-14 -
Your (b)(4) process for the manufacture of the API (b)(4) and (b)(4) results in quantifiable levels of (b)(4) Impurity (b)(4) at an irregular frequency.
FDA · FDA Warning Letter · 2022-11-01 -
All drugs from (b)(4) , FEI (b)(4) , were listed on IA 66-40 on (b)(4) , and the firm was issued a warning letter on (b)(4) , for among other things, inadequate impurity testing, and lack of audit trails to support CGMP activities.
FDA · FDA Warning Letter · 2021-01-27
Counted as of 2026-09-24 — the search you land on shows today's figures, so it may differ slightly.
Source
MFDS, 「알기 쉬운 GMP 용어집」, Impurity Korean originalGRM Regulatory Glossary
243 GMP terms in one place
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