A certificate of compliance with the European Pharmacopoeia also called CEP is a document published by the EDQM (European Directorate for the quality of medicines) and which certifies that a substance with pharmaceutical purpose is well manufactured and controlled according to the equivalent monograph of the European Pharmacopoeia.
There is a second type of CEP, said CEP TSE confirms that the substance involved is consistent with the monograph of transmissible animal spongiform encephalopathy risk.
A PRC consists of 2 pages, more sometimes further analysis methods. It has a cartridge to be completed by the holder of the CEP to declare for what drug it is intended.
The CEP has a number of style “R1 – CEP 1998 – 145 – Rev01″ indicating in this case that the CEP obtained in 1998 and with the number 145 suffered a five-year renewal (R1, so in 2003) and a modified since (Rev01).
For a CEP, the manufacturer of a substance must file with the EDQM a technical file describing the product, its manufacturing, controls effectués… mode It is assessed by members of the EDQM and the manufacturing site is inspected by one of the European agencies.
The advantage of the CEP is considered that the technical file of the substance was assessed and that on applications for authorisations to market multiple of a drug in Europe, it is more necessary that each national agency to do this assessment. To the Agency and the pharmaceutical gain considerable time on the evaluation of the drug. Thus, CEP represents a kind of guarantee of quality and is therefore heavily used to active principles, especially if they are produced in some countries (such as the India or China) where quality standards differ from those in Europe.
There is a similar document: Drug Master File or Active Substance Master File, which is also obtained by the manufacturer of an active substance and that contains information on the mode of production of this substance and its quality. But the DMF is not directly based on a monograph of the European Pharmacopoeia and is never evaluated as such: it is always filed at the same time that a folder of application for leave on the market of a drug is evaluated each time.