Certificate of suitability of Monographs of the European Pharmacopoeia
The Certificate of Suitability of Monographs of the European Pharmacopoeia (English, abbreviation CEP ) serves to prove that a monograph of the European Pharmacopoeia is suitable for adequately testing the quality of a medicinal product .
Manufacturers and distributors of medicinal products can apply to the European Directorate for the Quality of Medicinal Products (EDQM) for a CEP for active ingredients that are monographed in the European Pharmacopoeia (Ph. Eur., Pharmacopoeia) . Manufacturers must provide a detailed description of their manufacturing process and the impurities in the form of an impurity profile. It must be possible to detect all of the impurities in the relevant active ingredient that may occur during the manufacturing process using the analytical methods described in the Ph. Eur. If a CEP is issued, it certifies to the manufacturer or dealer that the active ingredient is adequately controlled by the Ph. Eur. Monograph . This uniform control system simplifies the trade in active pharmaceutical ingredients, since the pharmaceutical companies and drug authorities can rely on the CEP for drug approval . CEPs are recognized by the European Union and all signatory states to the European Pharmacopoeia Convention.
The basis for the CEPs is the RESOLUTION AP-CSP (07) 1 of the Health Committee of the Council of Europe .
In 1999, the certification system, which was originally limited to drug monographs, was expanded to include the pharmacopoeia monograph, which is generally applicable to “products with the risk of transmitting spongiform encephalopathy of animal origin” , taking into account the provisions of the pharmacopoeial chapter “Minimizing the risk of transmitting spongiform encephalopathy of animal origin” Medicinal products for human and veterinary use ” . Manufacturers of affected substances, which also include pharmaceutical auxiliaries (such as gelatine ), can have them assessed for compliance with the requirements described. As a result, a "TSE certificate" is issued, which is recognized by all European authorities.
Individual evidence
- ↑ EMA Pre-Submission Guidance ( Memento of the original dated November 1, 2016 in the Internet Archive ) Info: The archive link was inserted automatically and has not yet been checked. Please check the original and archive link according to the instructions and then remove this notice.
