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.

5 comments:

  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.

    ReplyDelete
  2. Awesome information. Certification is more important to start your career.
    Corey Organics is a company which encourages talent and recruit brightest employees.

    Click

    ReplyDelete
  3. Thank you for sharing this blog, It is very nice and very informative. I like your blog it would be very nice if I can get your blog more over on Pharmaceutical Drug Master File. I would like to share with you about Pharma Business Vietnam Company in Mumbai, India the organization's dossiers counseling is at the most elevated amount to accomplish anything at whenever for the expansion of the organization. It is also a Pharmaceutical DFM India the company has an extensive variety of items with the best administrations and great nature of creation. The company is highly specified within healthcare of the people and the company has Pharma regulatory affairs services with the best quality products.

    ReplyDelete
  4. Thanks a lot very much for the high quality and results-oriented help.
    I won’t think twice to endorse your blog post to anybody who wants
    and needs support about this area.


    syringe infusion pumps manufacturers

    syringe pumps manufacturers

    syringe pump suppliers

    ReplyDelete
  5. I feel really happy to have seen your webpage and look forward to so
    many more entertaining times reading here. Thanks once more for all
    the details.


    syringe infusion pumps

    infusion pumps manufacturers

    patient monitor manufacturers

    ReplyDelete