グローバルに通用する GMP査察システムを目指し …

1 GMP GMP 23 GMP PMDA GMP PIC/S PIC/S GMP GMP GMP PIC/S EU MRA GMP GMP GMP H22 PIC/S WG H21 GMP PMDA PMDA GMP PIC/S GMP GMP H23 21 3 GMP PMDA PMDA (H22 ) (H22 ) (H21 H22)GMP GMP GMP GMP PIC/S PIC/S: Pharmaceutical Inspection Convention andPharmaceutical Inspection Co-operation Scheme PIC/S EU FDA PIC/S PIC/S PIC/S 1/95 3.

2 PIC/S (a) GMP (b) Voluntary basis (c) (d) (e) GMP (f) MRA PIC/S GMP GMP GMP GMP GMP GMP PIC/S GMP PIC/S 8100 1 on site 2 3 Follow up visit 7 25 Pre Accession Procedure PS W/ 1/2011 ANNEX2

3 GMP GMP PIC/S, EU, WHO GMP chief inspector PIC/S GMP PMDA GMP 3 / GMP PIC/S GMP PIC/S GMP PIC/S PIC/S PIC/S GMP GMP GMP/QMS 42 GMP

4 PIC/S PIC/S GAP GMP GMP GMP PIC/S PIC/S GMP GMP GMP GMP PIC/S GMP/GQP GMP ( ) GMP ICH Q7, Q8, Q9, Q10 GMP/GQP PIC/S GMP Part1 Annex1 20 4,5,18,20 PIC/S GMP Part2(Annex18)Annex20 Annex4, 5 PIC/S PIC/S GMP ( ) ( ?)

5 GMP/GQP PIC/S GMP PIC/S ICH GMP/GQP GMP GMP PMDA PMDA GMP PIC/S PIC/S 21 22 PIC/S WHO (EMA,ZLG ) (22 ) GMP GMP 21 22 PIC/S WHO PIC/S PI002 3 Quality system requirements for pharmaceutical inspectorates Quality Indicator CAPA GMP PIC/S WHO Technical Report Series.

6 2002 Annex8 PIC/S WHO 10 2 1 WHO (EMA,ZLG ) (EMA) ZLG EMA GMP/GDP ( ) EU PIC/S BMG( ) ZLG( ) 2 BMG BfArM Paul Ehrlich Institut 2 ZLG 16 27 GMP 9 EMA, ZLG ZLG EU 1 16 EU MRA ZLG 6 2 GMP EMA GMP Inspectors Working Group PIC/S ZLG 27 GMP 9 (OMCL)

7 1 ZLG ZLG 13 EMA, ZLG EMA, ZLG EMA EU 2 EU GMP GMP EU EC(European Commission) EC 4 David Cockburn EMA 21 22 GMP =8 EU=10 =6 PMDA=7 =7 01234567891011 OthersPMDA Prefecture Sterile (man day s)API (man day s)

8 0%10%20%30%40%50%60%70%80%90%100%2439303 33314101011116251605656 Document Labo tour Plant tour 6 EU FDA WaterHVACPest controlTec. Transfer (Manufacturing)Tec. Transfer (Analysis)Development Reportrisk managementBioderived MaterialApplication file Others Prefecture GMP GMP 21 4 12 3 22 3 18 1 23 2 3 48 (47 PMDA) 264 2010 10 1 11 11 3 66 1 43 , 136 , 57% , 102.

9 43% GMP GMP 48 EMA FDA ISO 19011 ( ) . 1 1 1 2 1 3 4 2 QMS GQP GMP 1 4 1 5 .. 5 5 ( ) SOP GMP PMDA ( )

10 PMDA PIC/S MHLW PMDA GMP PIC/S PIC/S GMP PMDA GMP GMP PIC/S GMP PIC/S GMP