Glossary
Impurity
Any component of an API or a finished product that is not the intended active ingredient or excipient.
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 -
Your investigation of the (b)(4) impurity in (b)(4) active pharmaceutical ingredient (API) is deficient.
FDA · FDA Warning Letter · 2022-09-27
