CGMP for Finished Pharmaceuticals –Subpart D
Subpart D – Equipment Subpart D – 설비 Sec. 211.63 Equipment design, size, and location. Sec. 211.63 설비 디자인, 크기, 위치 Equipment used in the manufacture, processing, packing, or holding of a drug product shall be of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance. 의약품의 제조, 가공, 포장 또는 보관에 사용되는 설비는 예정 용도에 적합한 운전과 ..
2021. 8. 5.