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. GMP 3.

2 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 !! GMP 2015/03/17 GMP Seminar @ Toyama Pharmaceutical Association Copyright CM Plus Corporation. All Rights Reserved.

3 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. 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.

4 All Rights Reserved. 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.

5 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 !

6 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.

7 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 ?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 ?

8 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. 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 !

9 ! !? PIC/S GMP !!82015/03/17 GMP Seminar @ Toyama Pharmaceutical Association Copyright CM Plus Corporation. All Rights Reserved. 15 PQR ProductQualityReview 1 1 PIC/S Part I, Part II, ICH Q7, 21 CFR 211, Subpart J, (e) Annual Product Review Product Annual Review 26 6 13 !!2015/03/17 GMP Seminar @ Toyama Pharmaceutical Association Copyright CM Plus Corporation. All Rights Reserved.

10 16 PIC/S GMP Part I1. 2. 3. 4. CAPA 5. 6. 7. 8. 9. 10. 11. 12. GQP GMP !! 92015/03/17 GMP Seminar @ Toyama Pharmaceutical Association Copyright CM Plus Corporation. All Rights Reserved. 17 ?? A 10 1 Cpk 1 ?