Certificate of suitability of a medicinal product. Active substance master file

Title

Poster

Description

Lora Petrova, Emil Hristov, Kalina Andreevska
Faculty of Chemistry and Pharmacy, Sofia University "Saint Kliment Ohridski", Bulgaria

Subject

Aim: To analyze and present the current regulatory requirements for the quality of active substances involved in the composition of medicinal products. Materials and Methods: We conducted documentary and content analysis of the requirements for the pharmaceutical dossier in the section Quality of active substances published by EMA, Guideline on Active Substance Master File Procedure (ASMF), FDA and the Certificate of suitability Guidelines ( CEP) by the European Directorate for the Quality of Medicines and Healthcare (EDQM). Results and Discussion: CEP is a certificate issued by EDQM, which confirms that active substances are manufactured in accordance with the European Pharmacopoeia monographs and that if the monographs are applied strictly, the substance is suitable for use in medicinal products. The certificate is issued for synthetic active substances, herbal and for those at risk of transferring transmissible spongiform encephalopathy agents. Biological substances are outside the scope of the procedure. ASMF is a dossier prepared by the manufacturer of a non-biologically active substance, which contains detailed information on all sections of Part 3.2.S of Module 3 of the pharmaceutical dossier. ASMF is an auxiliary document for the registration of a medicinal product, certifying its purity and quality. It includes detailed information of the chemical properties of the medicinal product, manufacturing process, purity, impurities, packaging, stability. Conclusion: The use of ASMF and CEP guarantees the availability of qualitative, safe and efficient medicinal products. The preparation of ASMF is a specific pharmaceutical knowledge and requires extensive scientific preparation from Masters of Pharmacy.
Keywords: CEP, ASMF, EMA, EDQM