Glossary
Purity Test
A test confirming that the types and amounts of impurities in a sample meet the defined criteria.
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, the COA reports and batch records that you provided do not include an appropriate assay test for active ingredient content or impurity testing.
FDA · FDA Warning Letter · 2024-04-02 -
For example, the certificate of analysis (COA) reports that you provided do not include an appropriate assay test for active ingredient content or impurity testing.
FDA · FDA Warning Letter · 2024-03-26 -
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
