Glossary
Purity Test
A test confirming that the types and amounts of impurities in a sample meet the defined criteria.
Source · MFDS, 「알기 쉬운 GMP 용어집」, Purity Test 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, 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 -
In your response, you state that you initiated a change control request “to modify the system to ensure (b)(4) impurity testing is included” and tested raw materials for (b)(4) impurities.
FDA · FDA Warning Letter · 2026-09-29 -
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
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」, Purity Test Korean originalGRM Regulatory Glossary
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