EDQM publishes new Requirements for the CEP Certification Procedure

GMP News
16 July 2008
 

EDQM publishes new Requirements for the CEP Certification Procedure

  
In June the European Directorate on the Quality of Medicines and HealthCare (EDQM) published some revised documents and procedures regarding the CEP Programme. In the following you will find information taken from the press release:

Providing samples
The Certification Division announced that its policy concerning Certification samples will change from 1st July 2008. Instead of providing samples for every new 'chemical' or 'herbal drug/herbal drug preparation' application for a Certificate of Suitability, a commitment to provide samples of the substance and/or its impurities when requested by the EDQM should be provided. The application form has been updated accordingly and in particular Annex 6 has been added.

New system for revision/renewal of CEPs
The system for revision/renewal of CEPs will change for all requests for revision received from 1st July 2008. The main change to the system is that minor revisions to the Certification dossier, which do not cover a change in the specification of the final substance and which do not affect the content of the CEP, will not lead to the revision of the CEP after approval. To allow this modification, the minor change coded R3 has been split into two separate variations.
The following documents have been revised accordingly, and several other clarifications have been introduced:
Guideline on revision/renewal of certificates of suitability to the monographs of the European Pharmacopoeia (PA/PH/CEP (04) 2 3R)
Procedures for management of revisions/renewals of certificates of suitability to the monographs of the European Pharmacopoeia (PA/PH/Exp. CEP/T (04) 18)
Application form for revision/renewal.

Note for the applicants: Procedure for validation of new applications
This document presents the measures taken for the validation of new applications for a CEP that were put in place in 2007 and how to avoid the blockage of an application at receipt. More information ...

Source: EDQM Webpage
  

Cookies help us in providing our services. By using our services, you agree that we use cookies. Further information

OK

Go back

GMP Conferences by Topics

Cookies help us in providing our services. By using our services, you agree that we use cookies. Further information

OK