In January 2019, the revised EDQM ‘Guideline on requirements for revision/renewal of Certificates of Suitability to the European Pharmacopoeia Monographs’ will enter into force.
Less than one month to enter into force the revised EDQM guideline on requirements for revision/renewal of CEPs.
Remarkable changes include:
- the classification of changes related to the introduction of a new manufacturer of a starting material
- explicit reference to recent changes in the regulatory environment (e.g. ICH M7)
- the possibility to introduce/change a Risk management summary (RMS), in the context of the implementation of ICH Q3D in the Certification procedure.
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.
Examples include the introduction of a new substantially different route of synthesis (even when the impurity profile of the final substance is equivalent), unless it replaces the current process, or the addition of a new manufacturing site of the final substance which does not belong to the same group, even when specifications are unchanged.
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