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.

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

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