EDQM: Revision of Certification of Suitability for a Sartan monograph
As reported earlier, the European Pharmacopoeia Commission implemented five new sartan monographs in a rapid procedure at the end of February. They are scheduled to become effective already on 1 April 2021. For holders of a Certification of Suitability (CEP), this may, but does not necessarily, mean adjusting their control strategies for nitrosamine impurities. EDQM has now published supplemental information on this topic:
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.
Source:
EDQM: Revision of CEPs referring to one of the “sartan” monographs following their rapid implementation
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