PIC/S GMP DATA INTEGRITY PQSに関する取り組 …

1 PIC/S GMP data INTEGRITY PQS 2017 9 1 2017 9 5 1 44 2017 GMP GMP PMDA Annex 1 WG INTEGRITY 4. 5. GMP PMDA Annex 1 WG INTEGRITY 4. 5. 29 1 PMDA PMDA (2006 -2016 ) 50204060801001201401601802002006(H18)200 7(H19)2008(H20)2009(H21)2010(H22)2011(H2 3)2012(H24)2013(H25)2014(H26)2015(H27)20 16(H28)DomesticChinaIndiaAsia othersAfricaSouth AmericaNorth AmericaEurope(1%)(6%)(21%)(24%)(26%)(43% )(35%) (48%)(43%)(54%)(49%) 2014 2015 2016 1 35 33 412 34 25 183 24 19 154 18 13 135 10 11 106 9 7 (IQ,OQ,PQ.)

2 87 (IQ,OQ,PQ. )7 (IQ,OQ,PQ. )5 78 5 5 69 5 5 610 4 5 4 4 2016 6 GMP PMDA Annex 1 WG INTEGRITY 4. 5. Regarding the draft revision of Annex 1 (sterile manufacturing) to the PIC/S and EU GMP Guide by the PIC/S EMA Working Group on Annex 1, chaired by UK / MHRA, a joint public consultation will be launched with the EMA. The Committee agreed to involve WHO in the joint publication of this document, as well as in several other future PIC/S guidance release: PIC/S Meetings in Geneva (Switzerland)From 8 to 10 February 2017 EMA PIC/S Annex1 EMA PIC/S Public Consultation 8 Annex 1 WGPIC/S data INTEGRITY DI) Web 9 WG etc.

3 GMP GDP (Industry Practice) PIC/S PIC/S DI (DRAFT PIC/S GOOD PRACTICES FOR data MANAGEMENT AND INTEGRITY IN REGULATED GMP/GDP ENVIRONMENTS) 10 ? ? DI (DRAFT PIC/S GOOD PRACTICES FOR data MANAGEMENT AND INTEGRITY IN REGULATED GMP/GDP ENVIRONMENTS) 11 ICHQ9 Quality Culture DI (DRAFT PIC/S GOOD PRACTICES FOR data MANAGEMENT AND INTEGRITY IN REGULATED GMP/GDP ENVIRONMENTS) 12 Attributable( ) Legible( ) Contemporaneous( ) Original( ) Accurate( ) Complete( ) Consistent( ) Enduring( ) Available( )13 3 Good Documentation Practices (GDocPs)ALCOA +Attributable( ) ?

4 14 ALCOA+Contemporaneous( ) 15 ALCOA+Complete( ) * 16 ALCOA+ GMP PMDA Annex 1 WG INTEGRITY 4. 5. PIC/S DI Guideline ( ) 2016 PMDA GMP 18 data INTEGRITY 19 20 21 22 23 24 25 26 27 28 29 30 31 *

5 32*Fraud triangle: Donald R. Cressey GMP PMDA Annex 1 WG INTEGRITY 4. 5. 1. 2. 3. 4. 34 25 8 30 GMP PIC/S GMP 1. 35 2. 36 2015 2 4 2015 5 GMP 2015 7 GMP 11%46%11%22%4%4%1%1% 50 500 1000 3000 5000 1 3 3 24%17%13%13%18%15% OTC 3750 50 500 500 1,000 1,000 3,000 3,000 5,000 5,000 1 1 3 3 3.

6 2015 2 13 4 17 438 27%22%35%11%4%1%0% 50 100 300 500 1000 2000 2000 30%18%10%17%5%20% 3850 50 100 100 300 300 500 500 1,000 1,000 2,000 2,000 3. 3. 12%13%66%9% 0%10%20%30%40%50%60%70%80%90%100% 0%10%20%30%40%50%60%70%80%90%100% 0%10%20%30%40%50%60%70%80%90%100% 0%10%20%30%40%50%60%70%80%90%100% 39(a)(b)(c)(d)(a)(b)(c)(d)686668843981 a b c d e f g 3. 40252824351341 100 433844492640 100 abcdefgaaafbbbcccdddeeeffgg3.

7 41050100150200250300350 (a)(b)(c)(a)(b)(c)3. 54613514203417 a b c d e f g 4224221571393 100 303920772514 100 abcdefgaaabbbcccdddeeefffggg3. 70%30% 0%10%20%30%40%50%60%70%80%90%100% ( )0%10%20%30%40%50%60%70%80%90%100% 0%10%20%30%40%50%60%70%80%90%100% 0%10%20%30%40%50%60%70%80%90%100% 43(a)(b)(a)(b)3. 051015202530354045 PIC/S GMP GMP 443. 15%75%4%6% 0%10%20%30%40%50%60%70%80%90%100% ( )0%10%20%30%40%50%60%70%80%90%100% 0%10%20%30%40%50%60%70%80%90%100% ( )0%10%20%30%40%50%60%70%80%90%100% 45(a)(b)(c)(d)(a)(b)(c)(d)46 47 48 4.

8 12% 30% 49 1. 2. 3. Plan Do Check Action GMP GMP ( , GMP QRM , CAPA, OOS, QRM CAPA RM 50 Plan Do Check Action GMP GMP ( , GMP QRM , CAPA, OOS.))

9 QRM CAPA RM 51 Plan Do Check Action GMP ( , GMP QRM , CAPA, OOS, QRM CAPA RM 52 GMP 53 PMDA (CAPA) 54 (1) (2))

10 (3) (4) (5) (6) 55 (1) (2) (3) (4) (5) (6) (7) 56 57 PIC/S GMP 12 Plan Do Check Action GMP GMP ( , GMP QRM , CAPA, OOS.)