Certification procedure

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Useful background • Resolution AP-CSP(07) 1 of the CoE: Describes the process for the <strong>Certification</strong> <strong>procedure</strong> • Content of the (CEP) dossier PA/PH/CEP (04) 1, 4R Both available on EDQM website Andrew McMath 29/01/10 ©2010 EDQM, Council of Europe, All rights reserved
Useful background • Notes for guidance (ICH + CHMP/CVMP) apply, in particular: • Impurities testing (ICH Q3A + Ph. Eur. General Monograph 2034, Substances for Pharmaceutical Use) • Solvents (ICH Q3C = Ph. Eur. general text 5.4 ) • Specifications limits for residues of metal catalysts or metal reagents (CHMP/SWP) • Limits of genotoxic impurities (CHMP-SWP) • (Stability testing (ICH Q1 + CHMP guidelines for existing substances.) • GMP (ICH Q7, Annex 1 to EU GMP) • TSE (CPMP/CVMP guideline = PhEur general text 5.2.8) Andrew McMath 29/01/10 ©2010 EDQM, Council of Europe, All rights reserved
Page 1 and 2: The Certification Procedure Dr. And
Page 3 and 4: Regulatory background Active substa
Page 5 and 6: NfG CHMP/QWP/297/97 rev. 1 corr “
Page 7 and 8: Differences between CEP & ASMF - Sp
Page 9: Advantages of the CEP Provides: •
Page 13 and 14: Out of Scope of the Certification p
Page 15 and 16: Steering Committee • Representati
Page 17 and 18: Assessors and Certification Divisio
Page 19 and 20: How it works: Application Up-dating
Page 21 and 22: HOW TO READ A CEP Andrew McMath 29/
Page 23 and 24: The CEP, TSE : • Certifies that t
Page 25 and 26: And as necessary, chemical CEPs:
Page 27 and 28: And for a TSE certificate: • Coun
Page 29 and 30: How to use a CEP: Andrew McMath 29/
Page 31 and 32: KEY FIGURES Andrew McMath 29/01/10
Page 33 and 34: Certificates of Suitability … > 5
Page 35 and 36: Recent developments 1. New procedur
Page 37 and 38: Recent developments 3. Substances e
Page 39: Thank you ! ☺ Andrew McMath 29/01

Certification procedure

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