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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)
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