PMDAのGMP調査における 最近の ... - pref.kyoto.jp

1 PMDA GMP 28 2 29 3 8 13:30- 1 1. 2. GMP 3. 4. 5. 6. GMP 8. 9. 10. GMP 2 1. 2. GMP 3. 4. 5. 6. GMP 8. 9. 10. GMP 3 29 1 PMDA 4 GMP QMS GCTP ICH PIC/S IMDRF 26 11 25 5 PMDA GMP (Good Manufacturing Practice)

2 GCTP(Good Gene, Cellular, and Tissue-based Products Manufacturing Practice) QMS (Quality Management System) G 6 2016 1 PMDA PMDA PMDA 2 2 PMDA 7 PMDA GMP

3 GMP 28 3 28 6 9 4 PMDA 8 1. 2. GMP 3. 4. 5. 6. GMP 8. 9. 10. GMP 9 1700 10 27 6 18 11

4 PIC/S 12 180 233 214 297 131 185 198 169 163 165 788 893 741 2003 1324 1283 1595 1418 1678 1649 1039 1014 1160 2231 1160 1538 1588 1511 1882 1721 050010001500200025002006(H18)2007(H19)20 08(H20)2009(H21)2010(H22)2011(H23)2012(H 24)2013(H25)2014(H26)2015(H27) (2006 2015 ) (19%) (21%) (22%) (13%) (9%) (13%) (11%) (11%) (9%) (9%) 13 (2006 4 -2016 9 ) 0204060801001201401601802002006(H18)2007 (H19)2008(H20)2009(H21)2010(H22)2011(H23 )2012(H24)2013(H25)2014(H26)2015(H27)201 6 (H28) 3 7 29 49 27 45 57 42 49 63 28 DomesticAsiaAfricaSouth AmericaNorth AmericaEurope (45%) (2%) (5%) (20%) (26%) (25%) (43%) (45%) (48%) (43%) (55%) 14 PIC/S MRA 15 1.

5 2. GMP 3. 4. 5. 6. GMP 8. 9. 10. GMP 16 28 15 0115 GMP 17 1. PMDA 3.

6 4. 5. PIC/S PMDA 18 19 20

7 1. 2. GMP 3. 4. 5. 6. GMP 8. 9. 10. GMP 21 PMDA S,A,B,C,D D C: () C,D D S,A,B,C C, D C D 291 74(14) 7(4) 80 27% EU 128 7(2) 0 7 5% 75 6(1) 1(1) 7 9% 33 2(1) 0 2 6% 486 109(30) 6(5*) 115 24% 22 PMDA SOP 29 ( ) 27 26 14 9 7 (IQ OQ PQ ) 7 5 2014 23 6 2014 2015 50 34 18 C D (%)

8 2014 2015 [1] 34 33 [2] 15 16 [3] 11 11 [4] 19 18 [5] 3 2 [6] 19 20 24 2014 2015 2014 2015 35 33 34 25 24 19 18 13 10 11 9 7 (IQ,OQ,PQ, ) 7 (IQ,OQ,PQ, ) 5 5 5 5 5 4 5 4 25 26 PV PV 27 1

9 28 29 30 31 1. 2. GMP 3. 4. 5. 6.

10 GMP 8. 9. 10. GMP 32 MHRA MHRA GMP Data Integrity Definitions and Guidance for Industry March 2015 2016/3 FDA Data Integrity and Compliance With CGMP Guidance for Industry DRAFT GUIDANCE 2016/4 EMA Good manufacturing practice (GMP) guidance to ensure the integrity of data 2016/8 PIC/S GOOD PRACTICES FOR DATA MANAGEMENT AND INTEGRITY IN REGULATED GMP/GDP ENVIRONMENTS 2017/2 33 - 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.