GMP施行通知の改訂 の背景と論点 - jpma.or.jp

1 Implementation of ICH Q8, Q9, Q10 Points to Consider ICH 25 2 15 GMP slide 2 JPMA / PMRJ PIC/S slide 3 JPMA / PMRJ PIC/S slide 4 JPMA / PMRJ PIC/S PIC/S PIC/S PIC/S PIC/S PIC/S slide 5 JPMA / PMRJ slide 6 JPMA / PMRJ PIC/S GMP : PIC/S GMP PIC/S GMP Q&A) slide 7 JPMA / PMRJ slide 8 JPMA / PMRJ GMP/QMS GMP/GQP GMP ( ) GMP ICH Q7, Q8, Q9, Q10 PIC/SGMP Part2(Annex18)

2 Annex20 Annex4, 5 GCP PIC/S GMP Part1 Annex 1 20 4,5,18,20 PIC/S GMP slide 9 JPMA / PMRJ slide 10 JPMA / PMRJ - -PIC/S GMP -ICH Q8/Q /Q10 > -FDA -EMA -Continued/Continuous Process Verification slide 11 JPMA / PMRJ GMP 6 1. 2. 3. 4. 5. 6. DQ/IQ/OQ/PQ GMP slide 12 JPMA / PMRJ GMP GMP 11 11 1 1 2 3 slide 13 JPMA / PMRJ GMP/GQP GMP ( )

3 GMP GCP ICH PIC/S GMP PIC/S GMP GMP/QMS slide 14 JPMA / PMRJ slide 15 JPMA / PMRJ ICHQ9 3 3 3 slide 16 JPMA / PMRJ 3 3 5 slide 17 JPMA / PMRJ 3 3 11 (8) 1 6 ( ) ( )

4 Slide 18 JPMA / PMRJ slide 19 JPMA / PMRJ 3 3 11 slide 20 JPMA / PMRJ 3 3 11 slide 21 JPMA / PMRJ 3 4 slide 22 JPMA / PMRJ -2 slide 23 JPMA / PMRJ -3 DQ,IQ,OQ,PQ Q7 PV)

5 Slide 24 JPMA / PMRJ Q10 - - - - Q9 - DQ/IQ/OQ/PQ - : Q8, FDA, EMA slide 25 JPMA / PMRJ slide 26 JPMA / PMRJ - - - > > slide 27 JPMA / PMRJ PIC/S - - - - slide 28 JPMA / PMRJ - - - - - - slide 29 JPMA / PMRJ - - - - 3 - Q8 - Q9 slide 30 JPMA / PMRJ - 3.

6 - slide 31 JPMA / PMRJ