Monday, 2 September 2013

Certificates of Suitability (CEP/COS)

Certificates of Suitability (CEP/COS)

CEP stands for Certification of suitability of European Pharmacopoeia monographs. COS (“Certificate of Suitability”) means the same and, even if often used, is not the official acronym.

The role of the CEP is to demonstrate that the purity of a given substance produced by a given manufacturer is suitably controlled by the relevant monograph(s) of the European Pharmacopoeia. By demonstrating that they have been granted a CEP for their substance, suppliers of raw materials can prove this suitability to their pharmaceutical industry clients. 

 CEP is granted by the Certification Secretariat of the European Directorate for the Quality of Medicines (EDQM). The CEP confirms that pharmaceutical substances or active pharmaceutical ingredients (API) are produced according to the monographs of the EP, and therefore meeting the requirements of EU directives for medicines.

Advantages of the CEP

  • Full confidentiality of the submitted data,
  • Centralized evaluation by the EDQM,
  • Recognized by all Member States of the European Pharmacopoeia Convention (36 countries) as well as by other countries,
  • Easing of the management of applications for marketing authorization (MAA) for medicinal products in these countries,
  • Simplifies the approbation of a medicinal product compared to the active substance master file (ASMF) or European drug master file (EDMF).

The Certificate of suitability is valid for five years from the date when the original certificate was granted. Regardless of any revisions treated in the meantime, the holder of a Certificate of suitability shall ask for the renewal of the Certificate of suitability six months prior to expiry date by providing an update of the certification dossier.


  1. Cadila Pharmaceuticals Ltd. is one of the largest privately held pharmaceutical companies in India. Cadila Pharmaceuticals in manufacturing. Active Pharmaceutical Ingredients (APIs) of the highest standard in an integrated cost effective manner. Spread over 80,000 square meter area, ISO-9001 & ISO14001 manufacturing facility at Ankleshwar, India is accredited by US FDA, EDQM – European Directorate of Quality Medicine, AIFA – Agenzia Italiana del Farmaco, TGA – Therapeutic Goods Administration, Australia and WHO. Our product basket includes branded and generic formulations covering more than 45 therapeutic segments, biotechnology products, plant tissue culture and more than 38 APIs and intermediates. In the services realm, our offering includes Pre-Clinical and Clinical Research as well as Contract Manufacturing.

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