Glossary
Active Ingredient
A component of a medicine intended to exert a pharmacological action or other direct effect in the diagnosis, treatment, or prevention of disease.
Source · MFDS, 「알기 쉬운 GMP 용어집」(안내서-0037-01, 2012), Active ingredient Korean original
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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1 Based on the records and information you provided, you did not demonstrate that you are testing your active ingredient ethanol for methanol.
FDA · FDA Warning Letter · 2024-05-14 -
Your firm failed to test your incoming components for identity prior to manufacturing your over-the-counter (OTC) drug products (e.g., active ingredients, glycerin, and water as a component)…
FDA · FDA Warning Letter · 2023-08-01 -
You also did not demonstrate that you are adequately testing your active ingredient ethanol for…
FDA · FDA Warning Letter · 2024-05-07
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」(안내서-0037-01, 2012), Active ingredient Korean originalGRM Regulatory Glossary
243 GMP terms in one place
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