Glossary
Manufacture
All operations of purchase of materials and products, production, quality control, release, storage, and distribution, and the related controls.
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
