Transcription of ②京都府薬事講習会「PICS GMP」13 03 12
1 GMP Consulting, Inc. E-mail: PIC/S GMP / good manufacturing Practicez z z z z z GCPGLPGQPGVPGPSPGRPGDPGSPGPPGEPGAMP cGMPz GMPz GMPz GMPz GMPz GMP GMP EU GMP GMPWHO GMP GMP GQP ICH ICH GMP( ) PIC/S PIC/S GMP GMP ISO-9001 z z z z z / / (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use): z z / GMP Consulting, Inc.
2 / z PIC/S PIC PIC Scheme Pharmaceutical Inspection Convention / Pharmaceutical Inspection Cooperation Scheme convention scheme z z z / z z / z / / Website 2012 11 / - zWHO GMP PIC/S GMP PIC Basic Standard zPIC PIC Scheme zEU GMP PIC/S GMP in parallel z PIC/S GMP GMP GMP PIC/S GMP Introduction Part I GMP Basic Requirements for medical Products Part II GMP Basic Requirements for ActivePharmaceutical Ingredients Annexes EU Qualified Person PartII GMP 10 11 12 PIC/S GMP A4-43 (2009 1 )A4-5 (GMP 2 1 2004 ) Quality Management Personnel Premise and Equipment Documentation Production PIC/S GMP GMP 13 14 15 16 17 18 19 20 Quality Control A4-1 ( 2 1 2005 ) GQP A4-5 (GQP 2 2004 )
3 PIC/S GMP GMP GMP, GQP GMP Q&A GMP FDC Act(EU Regulation)21 CFR 210, 211EU Directive 2003/94/EC USA GuidanceEU GuidelinePIC/S Guide ICH Guideline / / 17 6 1 101
4 1. 2. 3. / / Article 8 Production Area /
5 / z GMP GMP z GMP GMP z z PIC/S GMP PIC/S GMP ICH Q9 / /
