EDQM gives Clarification concerning Stability Data for APIs within the Certification Procedure

In a notice published on 1 September 2011 on its website, the EDQM pointed out that a CEP applicant for an API - described in a monograph of the European Pharmacopoeia - does not need to determine a re-test period. This is an optional feature which is assessed only at the request of the applicant. In this case, the re-test period will be mentioned in the CEP dossier. If the CEP contains no information about the re-test period, stability data had not been assessed.

The applicant for a marketing authorisation has to comply with the Guideline "

Stability Testing of existing active substances and related finished products" (CPMP/QWP/122/02 rev1 corr) and has to perform the following:

• Control of the API immediately before the manufacture of the finished product and confirmation of compliance with the specifications, or
• Definition of a re-test period based on the results of a long-term stability study

API manufacturers who submit a CEP application are thus freed from the obligation to indicate a re-test period resulting from stability studies.

Further information is also availanle in the original statement of the EDQM.

Author:
Dr Gerhard Becker
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)