Given the changes in these monographs, it is assumed that the referring CEPs currently in effect are already in compliance and therefore remain valid. Thus, there is no need to demonstrate compliance with the monographs. CEP holders will therefore not be contacted by the Certification Department, as usual.
Should CEP holders nevertheless wish to make changes to their control strategy, they are required to submit a request for "minor revision" in accordance with the EDQM Guideline on requirements for revision/renewal of Certificates of Suitability to the European Pharmacopoeia monographs (PA/PH/CEP (04) 2, 7R corr):
4.II.2.1 Change in the specification parameters and/or limits of the final substance
g) Change of a limit for a mutagenic impurity in the final substance specification according to the principles and limits of the ICH M7 guideline.
Conformity with the requirements of ICH M7 shall be clearly demonstrated.
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