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Excipients & Actives for Pharma No. 26, 2011 REGULATORY NEWS CEP procedure and the availability of CEP for BASF products Dominik Odenbach In order to guarantee consistent product quality, pharmaceutical manufacturers must be able to demonstrate standardized, reliable quality of pharmaceutical ingredients in line with existing pharmaceutical monographs. To ensure quality, the Certification Secretariat of the European Directorate for the Quality of Medicines (EDQM) grants Certificates of Suitability of Monographs of the European Pharmacopoeia (CEP) to manufacturers who can show that their production is compliant with the existing pharmaceutical monograph of the European Pharmacopoeia. To apply for this certificate, pharma ceutical ingredients manufacturers must present a comprehensive dossier, including information on chemistry, manufacturer, process, characterization, controls, reference standards, container closure systems, stability. The CEP procedure was created in 1994. CEPs are accepted in all 36 member states of the European Pharmacopoeia Convention. According to the EDQM, non-European countries also accept CEP (e.g. Argentina, Brazil, Malaysia, Mexico, New Zealand, Russian Federation, Singa pore, South Africa, Taiwan, and others). The CEP procedure has many advantages: • Efficiency through centralization Only the EDQM reviews the applications and grants CEPs. A DMF must be reviewed by indi vidual health authorities, but the CEP procedure is a single centralized evaluation. There is no duplication of work. Potential diver gences in assessment are avoided. • Less documentation Once granted, the CEP is only a few pages long whereas a DMF is a dossier with a large volume of documentation, which must be reviewed with each new registration. • Speed The information provided in the dossier is approved by the EDQM only once, with the granting of a CEP. After this, each CEPbased registration is processed quickly. • IP protection The CEP dossier is only reviewed by one pub lic regulatory body (EDQM). Customer benefits For the pharmaceutical manufacturer, the CEP makes it easier to assess suppliers and their materials, without the need for conducting timeconsuming and costly audits. Marketing authorizations are easier to manage because CEP replaces the majority of the application. For the pharmaceutical manufacturer, the CEP makes it easier to assess suppliers and their materials, without the need for conducting time-consuming and costly audits. BASF is seeking to achieve CEP for its active ingredients and selected excipients. This will allow the company to supply customers with products compliant with the quality standards of the European Pharmacopoeia. Plus, customers will benefit from a straightforward service solution. All of the following products have valid status and are classified under type chemistry (table 1): Time and cost The CEP procedure saves time (fixed time frames; a single regulatory body) and cuts costs for the industry and the licensing authorities. A CEP costs a one-off fee of approx. 3,000 euros, whereas a DMF will have to be provided to different health authorities, leading to multiple fees. Page 14
Excipients & Actives for Pharma No. 26, 2011 Substance number Substance Certificate holder Certificate number Issue date 1385 Acitretin BASF SE DE 67056 Ludwigshafen R0-CEP 2007-201- Rev 01 22/01/2009 1688 Articaine hydrochloride BASF PHARMA (EVIONNAZ) SA CH 1902 Evionnaz R1-CEP 2002-198- Rev 01 13/07/2010 541 Bupivacaine hydrochloride BASF PHARMA (EVIONNAZ) SA CH 1902 Evionnaz R1-CEP 2004-043- Rev 01 13/07/2010 267 Caffeine BASF PharmaChemikalien GmbH & Co. KG DE 67056 Ludwigshafen R1-CEP 1998-022- Rev 02 16/12/2009 543 Carbamazepine BASF PHARMA (EVIONNAZ) SA CH 1902 Evionnaz 891 Copovidone nominal K value 28 BASF SE DE 67056 Ludwigshafen 892 Crospovidone type A and B BASF SE DE 67056 Ludwigshafen Am Rhein 761 Dexpanthenol BASF SE DE 67056 Ludwigshafen 1200 Dobutamine hydrochloride 664 Dopamine hydrochloride 487 Ephedrine hydrochloride BASF PharmaChemikalien GmbH & Co. KG DE 67056 Ludwigshafen BASF PharmaChemikalien GmbH & Co. KG DE 67056 Ludwigshafen BASF PharmaChemikalien GmbH & Co. KG DE 67056 Ludwigshafen 721 Ibuprofen BASF Corporation US 78343 Bishop 1019 Isotretinoin BASF SE DE 67056 Ludwigshafen 2052 Macrogol 15 hydroxystearate BASF SE DE 67056 Ludwigshafen 1242 Mepivacaine hydrochloride 1354 Oxybutynin hydrochloride BASF PHARMA (EVIONNAZ) SA CH 1902 Evionnaz BASF PHARMA (EVIONNAZ) SA CH 1902 Evionnaz 0.9 R1-CEP 1998- 086-Rev 04 R0-CEP 2007-106- Rev 00 R0-CEP 2007-076- Rev 00 R0-CEP 2006-233- Rev 00 R0-CEP 2006-273- Rev 01 R0-CEP 2007-049- Rev 00 R0-CEP 2006-234- Rev 00 R1-CEP 2000-087- Rev 01 R1-CEP 1999-068- Rev 03 R0-CEP 2006-095- Rev 02 R1-CEP 2001-305- Rev 02 R1-CEP 2000-108- Rev 03 13/07/2010 10/10/2008 10/10/2008 04/11/2008 27/04/2010 27/04/2010 16/01/2008 18/07/2008 07/06/2011 17/11/2008 13/07/2010 13/07/2010 TABLE 1 BASF products for which CEP is available Page 15
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