Certification procedure

More documents

Recommendations

Info

All CEPs specify: • Unique Reference number (e.g. R0-CEP 2000-001-Rev01) • Title: clear definition of the substance + grade when requested (eg. micronised, sterile,…) • Holder + manufacturing site(s) • Monograph(s) concerned • Starting validity date • Line numbering and annex details if appropriate Andrew McMath 29/01/10 ©2010 EDQM, Council of Europe, All rights reserved
And as necessary, chemical CEPs: • Additional impurities/Solvents/Catalysts – With limits and methods • Re-test period – With storage conditions + container • Specs (limit + test) for a specific grade • Tests of the monograph which can be omitted • Use or non-use of materials of animal origin 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 and 10: Advantages of the CEP Provides: •
Page 11 and 12: Useful background • Notes for gui
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: The CEP, TSE : • Certifies that t
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

Create successful ePaper yourself

Delete template?

Save as template?