EDQM Publishes TOP TEN Deficiencies Found in Applications for CEPs

GMP News No. 873

GMP News
24 January 2007

EDQM Publishes TOP TEN Deficiencies Found in Applications for CEPs

The European Directorate for the Quality of Medicines & Health Care (EDQM) has published a document that helps companies to avoid mistakes in the CEP dossier. In the EDQM document you will find the following explanation:

"This document presents a summary of the main deficiencies found in the dossiers for certificates of suitability (CEP) for chemical purity assessed from April to July 2006. It is based on the content of the deficiency letters sent to the applicants after the first evaluation of 87 applications. From the data obtained the average number of questions per application was 9 and the actual number ranged from 1 to 25.
A previous analysis of the top ten deficiencies was presented in October 2005 during the Certification Conference in Istanbul and the recommendations made at that time have obviously been taken into account by applicants since improvement has been observed in the quality of the dossiers submitted since this conference."

According to the published list the most frequently found deficiency is

"TOP j (3.2.S.2.3): Lack of information on the declared starting material(s). Lack of information on the description of its route of synthesis, absence or insufficiency of its impurity profile (related substances, reagents, solvents, catalysts), and the carry-over of its impurities to the final substance (58.5% of dossiers).
In the case of short synthesis, when the starting material is a complex product, the quality and impurity profile of the material is of key importance, and its route of synthesis should be shortly described. The absence of carry-over of its impurities (including related substances, solvents and catalyst) should be demonstrated."

To read more about the other 9 TOP deficiencies, please click here:

Learn more about format, content and submission procedures for different types of dossiers like CTD, CEP, European ASMF and US-DMF – in the ECA education course

CTD, CEP and Active Substance Master File

from 26-27 March 2007 in Barcelona, Spain

Prepared by:
Oliver Schmidt
On behalf of ECA

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