PIC/S GMPガイドに沿った 医薬品品質システム

1 1 GMP Platform 2015/03/17 GMP Seminar @ Toyama Pharmaceutical Association PIC/S GMP 2015/03/17 GMP Seminar @ Toyama Pharmaceutical Association Copyright CM Plus Corporation. All Rights Reserved. 21. PIC/S PIC/S PIC/S GMP 2. GMP 3. EU GMP 4. Q9 1. PIC/S PIC/S PIC/S GMP 2.

2 GMP 3. EU GMP 4. Q9 22015/03/17 GMP Seminar @ Toyama Pharmaceutical Association Copyright CM Plus Corporation. All Rights Reserved. 3 GMP 26 8 26 87 cGMP21 CFR Part 210 211 Part 1271 EU-GMPE udraLex Volume 4 GMP WHO GMPT echnical Report !

3 ! GMP 2015/03/17 GMP Seminar @ Toyama Pharmaceutical Association Copyright CM Plus Corporation. All Rights Reserved. 44 1990 4 ICH: EU ICH (EC) (EMA) (EFPIA) FDA (PhRMA) WHO Health Canada (EFTA) (MHLW) (PMDA) (JPMA) 12015/03/17 GMP Seminar @ Toyama Pharmaceutical Association Copyright CM Plus Corporation.

4 All Rights Reserved. 5 ICH GMP uality afety fficacy ultidisciplinaryQ1 A F : (1994 2003) Q A B : (1995 97)Q3 A C : (1995 98)Q4B: (2009 Q5 A E : (1998 2005)Q6 A B : (2001)Q (Q7A) : GMP (2001) Q7B : GMPQ8 : (2006) Q9 : (2006) Q10 : (2010) Q11 : 2014) Q F: 2006 1990 4 GMP Seminar @ Toyama Pharmaceutical Association Copyright CM Plus Corporation. All Rights Reserved.

5 6 PIC / S: PIC EU PIC 1970 Pharmaceutical Inspection Convention GMP PIC Scheme 1995 Pharmaceutical Inspection Co-operation Scheme PIC / S= PIC and PIC SchemePIC PIC Scheme GMP 22015/03/17 GMP Seminar @ Toyama Pharmaceutical Association Copyright CM Plus Corporation. All Rights Reserved. 7 PIC / S 01020304050 EU FDA (2011) MHLW / PMDA (2012/03) 43 46 (2014/07) 47 TGA (1993)ICH (1990)PIC/SPIC2015/03/17 GMP Seminar @ Toyama Pharmaceutical Association Copyright CM Plus Corporation.

6 All Rights Reserved. 8 PIC / S 2010 GMP PIC/S GMP Guide PIC/S GMP Part I 4 Annex 6, 7, 11, 13 # GMP Platform 0216 7 PIC/S GMP Seminar @ Toyama Pharmaceutical Association Copyright CM Plus Corporation. All Rights Reserved. 9 PIC / S 0330 1 0330 3 GMP 0830 1 GMP GMP 2013 PIC/S GMP !

7 2015/03/17 GMP Seminar @ Toyama Pharmaceutical Association Copyright CM Plus Corporation. All Rights Reserved. 10 PIC / s gmp EU-GMP PIC/S PIC PIC/S GMP EU-GMP EudraLex Vol. 4 PIC/S GMP EU-GMP ? EU-GMP Directive PIC/S GMP EU Directive EU QP QualifiedPerson Authorised Person EU-GMP PIC/S 62015/03/17 GMP Seminar @ Toyama Pharmaceutical Association Copyright CM Plus Corporation.

8 All Rights Reserved. 11 PIC / s gmp Part I 1 2 3 4 5 6 7 8 9 Part II ICH Q7 EudraLex Quality System 2013 1 PIC/S 2015/03/17 GMP Seminar @ Toyama Pharmaceutical Association Copyright CM Plus Corporation. All Rights Reserved. 12 PIC / s gmp Annex 1 G4 Annex 2 Annex 3 Annex 4 Annex 5 Annex 6 Annex 7 Annex 8 ?

9 Annex 9 Annex 10 Annex 11 Annex 12 Annex 13 Annex 14 Annex 15 EudraLex Annex 16 Qualified Person Annex 17 Annex 18 ICH Q7 Part II Annex 19 ?Annex 20 ICH Q9 72015/03/17 GMP Seminar @ Toyama Pharmaceutical Association Copyright CM Plus Corporation. All Rights Reserved. 131. PIC/S PIC/S PIC/S GMP 2. GMP 3.

10 EU GMP 4. Q9 2015/03/17 GMP Seminar @ Toyama Pharmaceutical Association Copyright CM Plus Corporation. All Rights Reserved. 14 25 0830 1 GMP GMP !! !? PIC/S GMP !!82015/03/17 GMP Seminar @ Toyama Pharmaceutical Association Copyright CM Plus Corporation.