Glossary
Manufacture
All operations of purchase of materials and products, production, quality control, release, storage, and distribution, and the related controls.
Source · MFDS, 「알기 쉬운 GMP 용어집」, Manufacture Korean original
Related sections
WHO TRS 986 Annex 2, Part 1 의약품 제조 및 품질관리에 관한 규정 [별표 1]
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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Your firm failed to validate the processes used to manufacture your drug products.
FDA · FDA Warning Letter · 2024-07-23 -
Your quality unit (QU) failed to perform adequate oversight for the manufacture of your OTC drug products.
FDA · FDA Warning Letter · 2026-08-04 -
Your firm manufactures over-the-counter (OTC) topical drug products such as sunscreens, pain relief, and acne treatments.
FDA · FDA Warning Letter · 2022-08-16
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」, Manufacture Korean originalGRM Regulatory Glossary
243 GMP terms in one place
Each term is explained in plain language with its official source. Look it up here whenever you meet a term you don't know.
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