PIC／S加盟に向けて - npo-qa.jp

1 PIC/S GMP 26 2 21 3 13 1 GMP 5. 2 3 Global Drug Supply PIC/S FDA EMA API QbD) 4 PIC/S: Pharmaceutical Inspection convention and Pharmaceutical Co-operation scheme PIC/S GMP 1995 EU FDA PIC/S 5 41 43 (ANSM,ANSES) (BMG,ZLG) (VMD) ) ( ) 6 PIC/S 1/95 3.

2 PIC/S (a) GMP (b) Voluntary basis (c) (d) (e) GMP (f) MRA 7 GMP GMP PIC/S Expert Circle, Seminar GMP 8 PIC/S Communication Harmonization Collaboration Trust GMP 9 GMP GMP 10 PIC/S 11 2009 2010 2011 2012 2013 2014 PIC/S event Geneva South Africa Geneva Kyiv Geneva Ottawa Rome Paris US-FDA Japan Application GMP PIC/S GMP GAP GMP GMP

3 PIC/S GMP GMP PIC/S GMP PIC/S GMP GMP GMP Geneva 40th anniversary On-site assessment (API) On-site assessment 12 2009 2010 2011 2012 2013 2014 PIC/S event Geneva South Africa Geneva Kyiv Geneva Ottawa Rome Paris US-FDA Japan Application QMS GMP GMP OMCL PMDA GMP Geneva 40th anniversary On-site assessment (API)

4 On-site assessment 13 PIC/S , , , , , , PIC/S EU PIC/S EU PIC/S PIC/S 14 11 4 The Rapporteur in charge of the membership application of Japan / MHLW & PMDA & Prefectures provided the Committee with an oral update on the successful outcome of the on-site inspection visit performed by the Audit team, which took place on 9-13 September 2013. 15 Sub-committee (SCT) Circles (SCEC) Development (SCSD) and Reassessment (SC on Compliance SCC) (D)P Harmonization(GMDP SC) , Audit and Budget (RA&B SC) (COM SC)

5 4 12 1 16 17 PIC/S A A A A A A -memoire 18 Expert Circle GMDP IWG PIC/S Annex PMDA GMP GMP 19 GMP GMP PDA TRI Training Research Institute) NIBRT(National Institute for Bioprocessing Research and Training)

6 PAT PDA,ISPE, PMDA 20 PIC/S GMP PIC/S 21 22 GMP PIC/S GMP GMP GMP PIC/S GMP 23 GMP/QMS GMP/GQP GMP ( ) GMP ICH Q7, Q8, Q9, Q10 PIC/SGMP Part2(Annex18) Annex20 Annex4, 5 GCP PIC/S GMP Part1 Annex 1 20 4,5,18,20 PIC/S GMP 24 PIC/S GMP PIC/S GMP.

7 PIC/S GMP PIC/S GMP Q&A) GMP GMP PIC/S 25 11 1 PMDA HP GMP 26 27 ) GMP 28 ICHQ9 29 30

8 31 12 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 6. 10. 32 PMDA 33 3 3 11.

9 11 8 (8) 1 6 ( ) ( ) (1/2) 34 1. 2. 3. (2/2) 35 36 37

10 38 39 3 3 11. 11 8 (8) 1 6 ( ) ( ) (1/2) 39 (2/2) 3 8 40 41 C C