null EDQM revised guideline on Content of the dossier for chemical purity and microbiological quality

EDQM Strasbourg, France 14/12/2018

The revised EDQM guideline Content of the dossier for chemical purity and microbiological quality, PA/PH/CEP (04) 1, 6R will enter into force in January 2019. Changes included in this revised guideline reflect changes in the regulatory environment since the previous version was implemented in September 2015. These include, for example, the impact of and references to ICH M7 “Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk”, to ICH Q3D “Elemental impurities” and to ICHQ11 Questions and Answers.

Other notable changes include more situations where alternative options cannot be addressed using a single CEP application and would require a separate CEP application. Examples of where a new separate CEP application is required include alternative substantially different routes of synthesis (even when the impurity profile of the final substance is equivalent) or multiple manufacturing sites for the final substance which do not belong to the same group, or use of a material from more than one source where the TSE risk is different for the different sources.

Applicants are strongly encouraged to read the revised guideline as some of the changes may impact their regulatory strategy for CEP applications they intend to submit during 2019.