지난호 목차/소개
지난호에 수립되었던 국내외 기사와 Q&A 및 FAQ를 보실 수 있는 공간입니다.
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Part2 Technology Follow-up
GMP 일반
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미국과 EU의 GMP 동향
장형석 Vol. 1 -
GAMP 5냐, GAMP 4냐
장형석 Vol. 1 -
죽음 부른 GMP 위반사례 10 - Death by GMPs
Michael Anisfeld Vol. 1 -
새로운 명제 CAPA : 재발방지를 위해 당신은 무엇을 했는가?
Michael Anisfeld Vol. 1 -
GMP Top Issues - 15 Topics (상), (하)
권혁제 Vol. 3,4 -
제조실무를 위한 약사법 정리
편집실 Vol. 9 -
Changes to 21 CFR 210 and 211
편집실 Vol. 31
첨가제 GMP
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의약품 첨가제 위험성평가 및 공급자평가
Vol. 22 -
의약품 첨가제: 안전한 사용을 위한 고찰
Vol. 23 -
EU GMP Part3. Explanatory notes for pharmaceutical manufacturers on the preparation of a Site Master File and content of a Site Master File
Vol. 17 -
EU GMP Annex13. Investigational Medicinal Products
Vol. 26 -
Canada: Validation Guidelines for Pharmaceutical Dosage Forms
Vol. 45 -
The Use of Mechanical Calibration of Dissolution Apparatus 1 and 2
Vol. 58 -
Mechanical Qualification of Dissolution Apparatus 1 and 2
Vol. 66 -
VDMA information sheet: Riboflavin test for low-germ or sterile process technologies(Fluorescence test for examination of cleanability for food, aseptic, pharmacy and chemistry)
Vol. 76 -
EU GMP Part3. Explanatory notes for pharmaceutical manufacturers on the preparation of a Site Master File and content of a Site Master File
Vol. 17 -
EU GMP Annex13. Investigational Medicinal Products
Vol. 26 -
Canada: Validation Guidelines for Pharmaceutical Dosage Forms
Vol. 45 -
The Use of Mechanical Calibration of Dissolution Apparatus 1 and 2
Vol. 58 -
Mechanical Qualification of Dissolution Apparatus 1 and 2
Vol. 66 -
VDMA information sheet: Riboflavin test for low-germ or sterile process technologies(Fluorescence test for examination of cleanability for food, aseptic, pharmacy and chemistry)
Vol. 76