Glossary
Production
All the operations from receipt of materials, through processing and packaging, to the finished product.
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.
-
Your firm failed to follow written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(b)).
FDA · FDA Warning Letter · 2021-11-09 -
Component Testing You failed to conduct an identity test on each shipment of each lot of components used in the production of your drug products…
FDA · FDA Warning Letter · 2023-03-14 -
Your firm failed to adequately validate the manufacturing processes used for the production of your drug…
FDA · FDA Warning Letter · 2024-08-13
