Europe – Clarification on the acceptability of requests for revision of CEP applications

Following experience gained since the introduction of the revised EDQM Guideline on requirements for revision/renewal of certificates of suitability to the European Pharmacopoeia Monographs (PA/PH/CEP (04) 2, 7R corr) in January 2019, this announcement is intended to clarify a couple of items.

The EDQM Guideline on requirements for revision/renewal of certificates of suitability to the European Pharmacopoeia Monographs states that a separate CEP application should be made when a new substantially different route of synthesis is introduced (even when the impurity profile of the final substance is equivalent). For lifecycle management and transparency for all concerned parties, the EDQM expects that a separate application is made also when the route of synthesis is replaced by a new one, and the EDQM reserves the right to reject any such requests for revision for which a separate application would need to be made.

In addition, where different grades of material with different specifications are applied, the EDQM would also expect separate applications to be made (i.e. different polymorphic forms, different hydrates or sterile/non-sterile grades, whilst different particle sizes may still be included in the same CEP application when the impurity profile is shown equivalent)…