CRED Getting the CMC Dossier Right 2024

28/08/2024

Certificates of Suitability (CEP)

A manufacturer ....can provide proof that the quality of the substance is suitably controlled by the relevant monographs of the European Pharmacopoeia by a CEP granted by EDQM.

• ‘Chemical’ or ‘Herbal’ CEP

• To demonstrate that the quality of a substance is controlled by the Ph. Eur. monograph and additional tests if needed.

•’TSE’ CEP

To guarantee compliance with the general monograph on Products with TSE risk It DOES NOT certify that the quality of the substance is suitably controlled by a specific Ph. Eur. monograph

EDQM - Certification Secretariat of the European Directorate for the Quality of Medicines (www.edqm.eu)

The Organisation for Professionals in Regulatory Affairs

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Certificates of Suitability (CEP)

Inspection is an integral part of the Certification Procedure

•

To verify the compliance with submitted dossier

•

EU GMP Part II

•

EU GMP Annexes (e.g. Annex 1 / sterile substances)

• It DOES NOT replace a certificate of analysis

•It is NOT a GMP certificate

Include copy of CEP in MAA Module 1 (Annex 6.10)

Reduces info in Module 3.2.S but still need:

● specification (note additional tests on CEP)

● batch analysis data

● stability data (unless testing immediately prior to manufacture of DP)

The Organisation for Professionals in Regulatory Affairs

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