What is CEP for active pharmaceutical ingredient?
It’s not a secret that the composition of the drug includes two components: the active pharmaceutical ingredient (API) and excipients. To register a medicinal product with the regulatory authorities, it is necessary to provide a sufficiently large amount of information regarding the quality of the pharmaceutical substance, including a copy of Certificates of Suitability to the Monographs of the European Pharmacopoeia (CEP – The Certification of Suitability). In this article, we will talk about what CEP is.
The CEP is a document issued by the European Directorate for the Quality of Medicines (EDQM). Such a certificate confirms that the quality of the API is controlled in accordance with the requirements of the relevant monograph of the European Pharmacopoeia. With the help of CEP, the API manufacturer can provide evidence that the quality of the substance complies with the relevant European Pharmacopoeia monograph and can be used for the production of medicines.
This document can be provided (if available) in Module 1 of the registration dossier which is going to be submitted in the frame of EAEU procedure (Section 1.5.4.), as confirmation of the quality of the API included in the drug. It often happens that there are substances from different manufacturers in the composition of the drug, as in the example below:
Logically, a CEP should be provided for each API manufacturer.
When submitting a CEP check the following:
- Relevance of the CEP version, the availability of translation into Russian;
- Compliance of the addresses indicated in the CEP with other data of the registration dossier;
- Compliance of the manufacturing sites specified in the CEP with those declared in the dossier;
- Discrepancies between the information given in the CEP and the data in Module 3;
- Any characteristics described in the CEP (residual organic solvents, elemental impurities, packaging, recheck period (shelf life), etc.).
- Materials of the SCIENTIFIC-PRACTICAL CONFERENCE “MODERN APPROACHES TO THE EXAMINATION AND REGISTRATION OF MEDICINES” REGLEK — 2022