European Pharmacopoeia, Reference Standards & Certificate of Suitability

France

The European Pharmacopoeia (Ph. Eur.) provides official quality standards for medicines and their ingredients, including APIs, excipients and herbal substances. Ph. Eur. reference standards are used to verify the quality of substances as described in the monographs. The Certificate of Suitability (CEP) to the monographs of the European Pharmacopoeia procedure is a key element of the systems that ensure the quality of pharmaceutical substances marketed in Europe and beyond.

The European Pharmacopoeia (Ph. Eur.) provides quality standards to the pharmaceutical industry to control the quality of medicines and the substances used to manufacture them. It is a published collection of monographs and general texts that describe both the individual and general quality standards for ingredients, dosage forms and methods of analysis for medicines. These standards apply to medicines for both human and veterinary use. Compliance with the quality requirements of the Ph. Eur. is a prerequisite for medicines to be authorised for the markets of the 39 member states, making it a crucial resource for maintaining high standards in the pharmaceutical industry globally. National and international regulatory bodies rely on Ph. Eur. standards to evaluate and approve medicines, ensuring they are safe and effective for public use. Quality control laboratories use Ph. Eur. standards to test and validate the quality of pharmaceutical products, ensuring compliance with regulatory requirements.

The European Pharmacopoeia (Ph. Eur.) serves as a single reference for the quality control of medicines in 39 countries, all of which have signed the Convention on the Elaboration of a European Pharmacopoeia. The official standards in the Ph. Eur. provide a legal and scientific basis for quality control during the development, production and marketing processes. The 11th Edition of the Ph. Eur. contains 2520 monographs, 396 general texts and more than 2900 descriptions of reagents. It is available to order as a paper or online version. The online, bilingual (English and French) version offers a fully cumulative edition with direct access to complementary information in the Knowledge database and the Ph. Eur. archives for the duration of the subscription. It is smartphone friendly and users have access to additional features including toggling change marks in revised and corrected texts for improved readability and visibility of changes, direct links to texts and advanced searching. Ph. Eur. reference standards (RSs) are the only pharmacopeial source for verifying compliance with the legal requirements of the Ph. Eur. according to the corresponding monograph or general chapter of the European Pharmacopoeia. The EDQM supplies the RSs used in pharmaceutical analysis (e.g. for identification, purity tests or assays). The catalogue, which includes information on the RSs, is updated daily. The Certification of Suitability (CEP) to the monographs of the European Pharmacopoeia procedure is a key component of the systems that ensure the quality of pharmaceutical substances marketed in Europe and beyond. To obtain a CEP, a manufacturer must submit an application, describing the manufacturing process and control strategy applied, notably for the determination of impurities. The CEP procedure centralises the evaluation of the quality of pharmaceutical substances, benefitting both regulatory authorities and industry by saving time and resources and ensuring harmonisation in the assessment of data. CEPs replace the data in the quality part of MAAs, thus streamlining the process. Contact our team at Booth 4B129 to find out how CEPs can make a difference to your business and simplify access to markets in Europe and beyond.