Europe – Revised Guideline on requirements for revision/renewal of CEPs

The revised EDQM ‘Guideline on requirements for revision/renewal of Certificates of Suitability to the European Pharmacopoeia Monographs’ (PA/PH/CEP (04) 2 7R) will enter into force in January 2019.

Notable changes include the classification of changes related to the introduction of a new manufacturer of a starting material (see page 7), explicit reference to recent changes in the regulatory environment e.g. ICH M7 or, in the context of the implementation of ICH Q3D in the Certification procedure, the possibility to introduce/change a Risk management summary (RMS).

The document also lists an expanded number of situations where revision of an existing CEP will no longer be possible and a new separate CEP application is required…