Glossary
Drug Product / Medicinal Product
A medicine in its dosage form that has completed all stages of production, including final packaging.
Source · ICH Q7, §20 Glossary, Drug (Medicinal) Product; MFDS, 「알기 쉬운 GMP 용어집」, Drug Product Korean original
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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You lacked appropriate sampling and testing to ensure your drug products conform to appropriate…
FDA · FDA Warning Letter · 2025-10-07 -
Your investigations into rejected batches failed to extend to other batches, dosage strengths, and drug products for tablet compression machine settings.
FDA · FDA Warning Letter · 2022-12-06 -
You did not provide adequate stability data to demonstrate that the chemical properties of your drug products remain acceptable throughout the labeled expiry period.
FDA · FDA Warning Letter · 2021-01-26
Counted as of 2026-09-24 — the search you land on shows today's figures, so it may differ slightly.
Source
ICH Q7, §20 Glossary, Drug (Medicinal) Product; MFDS, 「알기 쉬운 GMP 용어집」, Drug Product Korean originalGRM Regulatory Glossary
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