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
  • 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
  • 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
Part 3 Hot Questions & Cool Answers
sureGMP/Forum
  • GMP Q&A

    Vol. 9~27
Health Canada
  • GMP Q&A

    Vol. 23