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cgmp5

CGMP for Finished Pharmaceuticals –Subpart I(시험관리) Subpart I - Laboratory Controls Subpart I – 시험 관리 Subpart I - Laboratory Controls Subpart I – 시험 관리 Sec. 211.160 General requirements. Sec. 211.160 공통 (a) The establishment of any specifications, standards, sampling plans, test procedures, or other laboratory control mechanisms required by this subpart, including any change in such specifications, standards, sampling plans, test procedures, or o.. 2021. 9. 7.
CGMP for Finished Pharmaceuticals –Subpart E Subpart E - Control of Components and Drug Product Containers and Closures Subpart E – 원료, 의약품 용기, 마개의 관리 Sec. 211.80 General requirements. Sec. 211.80 공통 (a) There shall be written procedures describing in sufficient detail the receipt, identification, storage, handling, sampling, testing, and approval or rejection of components and drug product containers and closures; such written procedures .. 2021. 8. 5.
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.
CGMP for Finished Pharmaceuticals –Subpart C Subpart C - Buildings and Facilities Subpart C – 건물 및 시설 Sec. 211.42 Design and construction features. Sec. 211.42 디자인 및 구조 특성 (a) Any building or buildings used in the manufacture, processing, packing, or holding of a drug product shall be of suitable size, construction and location to facilitate cleaning, maintenance, and proper operations. 의약품의 제조, 가공, 포장 또는 보관에 사용되는 건물은 세척, 유지 관리, 적절한 작업을 용이.. 2021. 6. 28.

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