Glossary
Assay (Content or Potency)
Also writtenpotency test
A test that accurately measures the content or potency of the analyte present in a sample.
Source · MFDS, 「알기 쉬운 GMP 용어집」, Assay: Content or Potency 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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We acknowledge the receipt of your assay method for medroxyprogesterone; however, you have not provided evidence to show that your (b)(4) method is equivalent or better than the compendial method established in the current USP.
FDA · FDA Warning Letter · 2023-08-08 -
For example, our investigator observed failing assay results for Phenylephrine at 3…
FDA · FDA Warning Letter · 2024-07-09 -
For example, the finished product testing reports you provided did not include appropriate assay testing for the identity and strength of each active ingredient or for impurities prior to release.
FDA · FDA Warning Letter · 2026-09-29
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」, Assay: Content or Potency Korean originalGRM Regulatory Glossary
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