Transcription of PIC/Sの動向とGMP調査の現状 - jpma.or.jp
1 PIC/S GMP 2015 2015 9 15 2015 9 18 2 Press release: PIC/S meetings in Rome (Italy)32012 3 9 PIC/S 2014 7 1 PIC/S 4 26 7 1 0701 2 PIC/S Sub Committee Communication 5 47 6 GMP (SCT) Circles (SCEC) Development (SCSD) and Reassessment (SC on Compliance SCC) (D)
2 P Harmonization(GMDP SC) , Audit and Budget (RA&B SC) (COM SC) 4 12 1 7 QRM Quality Risk Management) 89 QRM Expert Circle 1 QRM (Quality Risk Management) Advanced Training Course 2014 12 8 10 PIC/S 50 ( 3 QRM Expert Circle PIC/S QRM #n68 The overall goal is the development and provision of an advanced QRM training coursefor GMP Inspectors. This will enable Inspectors to effectively inspect Quality Risk Management activities and decisions on site at an advanced level and to also effectively use the 2012 PIC/S Recommendation in relation to risk based GMP inspection planning (PI 037/1). 10 PRESS RELEASE: PIC/S MAY 2015 A A A A -memoire PMDA PIC/S PIC/S 11 ANNEX 2 14 15 PIC/S GMP 2015 7 8 Expert CircleGMDP IWGPIC/SAnnex PMDA GMP 12 GMP/QMS/GTP GMP) QMS) GTP) GMP, , PIC/S GMP GDP QMS GTP GCTP PIC/S GMP WHO, EU MDSAP 13 1.
3 PIC/S GMP Guide Annex 1 GMP Annex WG 2. EU GMP/GDP IWG PIC/S Committee Annex Annex 14 ANNEX1 Annex1 2015 3 31 2015 5 PIC/S Committee 2015 6 GMDP IWG 2015 6 9 IWG 2015 10 2016 4 2016 6 GMDP IWG 2016 7 PIC/S Committee PS/W 1/2015 Concept paper on the revision of annex 1 of the guidelines on good manufacturing practice manufacture of sterile medicinal products 4. Proposed timetable 16 Annex1 Annex PDA ISPE COP GMP PMDA PIC/S PIC/S GMP Annex 1 27 5 20 1 Annex1 4 A B C D PIC/S GMP Annex 1 A B Annex1 PIC/S Annex 1 WG C D PIC/S Annex 1 WG Annex1 17 GMP 18 )
4 GMP GMP PMDA 19 ICHQ9 20 GMP 5 . 0830 1 21 22 12 1.
5 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 6. 10. 23 26 PMDA 25 12 2 26 6 13 24 251. 2. 3. ICH Q10) PIC/S CommunicationHarmonizationCollaborationT rust GMP 2627 100-0013 3-3-2 TEL 03-3506-9446 FAX 03-3506-9465 GMP,QMS,GCTP, G TEL,FAX
