Transcription of PIC/S GMPの最新動向と PMDAの指摘事例について
1 PIC/S GMP 1 43 2016 2016 9 12 2016 9 16 2 1. 2. PIC/S PMDA PIC/S 3. 4. 3 1. 2. PIC/S PMDA PIC/S 3. 4. 28 5 PMDA 4 PMDA GMP QMS GCTP ICH PIC/S IMDRF 26 11 25 5 GMP/GCTP QMS 6 PMDA PMDA PMDA 2 2 PMDA PMDA
2 7 8 9 1. 2. PIC/S PMDA PIC/S 3. 4. GMP PIC/S 2014 7 PIC/S PIC/S GMP GMP PIC/S : Pharmaceutical Inspection Co-operation Scheme 10 (ANSM,ANSES) (BMG,ZLG) (VMD) ( ) 46 49 11 PIC/S 12 12 QRM Quality Risk Management)
3 Expert Circle PIC/S WG ANNEX1 Integrity PIC/S EU GMP 1 Chapter1 2 3 5 6 7 8 A 1 A 13 17 21 Importer GMP GDP Guide Recommendations : Validation Master Plan ATMP GMP Guidance on Data Integrity Guidance on Classification of Deficiencies 13 Annex1 PIC/S GMP Guide Annex 1 GMP EU GMP/GDP IWG PIC/S Committee Annex1 2015 2 2 14 Annex1 2015 3 31 2015 5 PIC/S Committee 2015 6 GMDP IWG 2015 6 9 IWG 2015 10 2016 4 2016 6 GMDP IWG 2016 7 PIC/S Committee PS/W 1/2015 Concept paper on the revision of annex 1 of the guidelines on good manufacturing practice manufacture of sterile medicinal products 4.
4 Proposed timetable 2015 10 15 16 12 GMP/QMS/GTP GMP) QMS) GCTP) GDP) PIC/S GMP WHO, EU MDSAP G M P, PIC/S GMP QMS GTP GDP PIC/S 17 Annex1 PIC/S GMP Annex 1 Annex1 PDA ISPE COP COP PMDA 18 PQS QRM 19 1.
5 PQS) QRM GMP H26 4 PQS QRM 438 12% QRM QRM GMP 20 1. GMP 2014 2. H27 4 PV C A PA GMP 1. 2. 3. GMP 21 GMP GMP PQS) 22 23 1.
6 2. PIC/S PMDA PIC/S 3. 4. PMDA 24 25 GMP PMDA 26 SOP 29 ( ) 27 26 14 9 7 (IQ OQ PQ ) 7 5 2014 27 2013 2014 39 36 11 8 ( %) C D 28 - NaHCO3 g Lot 39450 Lot 39451 Audit trail URS CSV Data Integrity The degree to which a collection of data is complete, consistent and accurate (FDA Glossary of computer System Software Development Terminology (8/95)) user QA.
7 Reviewer SOP 29 IR PDF ID Software 30 31 1. 2. PIC/S PMDA PIC/S 3. 4. 32 33 2007 2008 2015 2016 2007 2008 90 U S P, E P, J P 2 2007 2008 34 2015 27 12 3 35 1.
8 2016 28 4 26 PMDA 36 A A A GMP 3 1 3 7 3 10 1 3 11 1 1 2 37 28 15 0115 3 GMP 38 39 28 QA 3 40
9 41 GMP 42 MF MF MF MF MF MF PMDA GMP/QMS GMP QMS OJT PMDA PMDA / / / 43 PMDA HP GMP/QMS GMP/QMS 44 45 100-0013 3-3-2 TEL 03-3506-9446 FAX 03-3506-9465
