Glossary
Identification Test
Also writtenidentity test
A test confirming that the main component, or a specified component, of a sample is the substance it is intended to be.
Source · MFDS, 「알기 쉬운 GMP 용어집」, Identification 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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Your firm failed to perform identification testing on raw materials and components including APIs prior to use in your OTC drug products.
FDA · FDA Warning Letter · 2026-09-29 -
For example, your supplier’s COA for (b)(4) lacks Identification Test A, Impurities - Lead test, Iron and Other Heavy Metals test, Alkalinity test, and Carbonate and Color of Solution test.
FDA · FDA Warning Letter · 2026-10-06 -
Because you did not perform identity testing on each shipment of each lot using the USP identification test or an equivalent validated method that detects these hazardous impurities, you failed to assure the acceptability of these components for use in the manufacture of your drug products.
FDA · FDA Warning Letter · 2026-10-13
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」, Identification Test Korean originalGRM Regulatory Glossary
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