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PIC Sの概要について - jpma.or.jp

PIC/S .. 2010 9 6/9 .. GMP /S .. GMP .. Pharmaceutical Inspection Convention PIC .. Pharmaceutical Inspection Co-operation Scheme PICS .. PIC/S . GMP . PIC 1970 10 . EFTA: European Free Trade Association .. GMP .. GMP .. GMP / . / 1995 11 2 . / .. GMP / .. GMP PIC/S . PIC/S .. 1970 1994 24 10 18 8. 1995 - 2005 10 18 28 10. 2006 - 2015 9 28 38 10. 2006 - 2010 4 28 37 9. GMP PIC/S .. GMP PIC/S .. GMP .. GMP .. 1 . GMP . Aide Memoire Annex . GDP .. GMP PIC/S GMP . / . 2 / . / .. ) .. WHO EMA(EMEA) EDQM UNICEF.. GMP / . EU . EU.

pic/sの概要について 日本製薬工業協会GMP事例研究会 2010年9月6/9日. 前田年秋. 製薬協gmp事例研2010.9.6/9

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Transcription of PIC Sの概要について - jpma.or.jp

1 PIC/S .. 2010 9 6/9 .. GMP /S .. GMP .. Pharmaceutical Inspection Convention PIC .. Pharmaceutical Inspection Co-operation Scheme PICS .. PIC/S . GMP . PIC 1970 10 . EFTA: European Free Trade Association .. GMP .. GMP .. GMP / . / 1995 11 2 . / .. GMP / .. GMP PIC/S . PIC/S .. 1970 1994 24 10 18 8. 1995 - 2005 10 18 28 10. 2006 - 2015 9 28 38 10. 2006 - 2010 4 28 37 9. GMP PIC/S .. GMP PIC/S .. GMP .. GMP .. 1 . GMP . Aide Memoire Annex . GDP .. GMP PIC/S GMP . / . 2 / . / .. ) .. WHO EMA(EMEA) EDQM UNICEF.. GMP / . EU . EU.

2 GMP PIC/S GMP .. / . GMP PIC/S .. PIC/S .. GMP .. GMP .. 2010 1 1 2014 12 31 . 2015 1 1 PIC/S GMP . ASEAN. 10 .. 2 . 3 . GMP GMP .. z MRA PIC/S 2007 .. z PIC/S J Morenas B Tribe . z 3 GMP GMP EU-GMP GMP .. z PIC/S 2008 2009 PMDA . GMP . z GDP ( WHO EU .. GMP PIC/S . 2010 5 19 20 . 2010 1 1 Tor Graberg /MPA . PIC/S . 2010 4 16 Medsafe . PIC/S . PIC/S Roszdravnadzor . MoU PIC/S . 2010 11 1 NADFC .. PIC/S GDP . EU WHO GDP . PIC/S GDP .. GMP PIC/S . 2010 5 19 20 . 2010 .. 2 PIC/S ASEAN PIC/S . 2010 11 12 .. WHO . 2010 11 8 9 .. GMP THE END.)

3 GMP


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