Division Certification of Substances
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CP/CB
PUBLIC DOCUMENT
(Level 1)
English only/Anglais seulement
PA/PH/Exp. CEP/T (06) 35
Strasbourg, December 2006
Certification of suitability of Monographs of the European Pharmacopoeia
How can the content of the applications for a certificate of suitability for chemical
purity be improved?
The TOP TEN deficiencies found in applications
PA/PH/Exp. CEP/T (06) 35
2
Certification Unit
The TOP TEN deficiencies found in applications
How can the content of the applications for a certificate of suitability for
chemical purity be improved?
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.
By including the recommendations described in this text together with the requirements
described in the guideline in the submission (“Content of the dossier for chemical purity”
(PA/PHCEP0413R) available on our website which replaces Annex I to Resolution AP-CSP
(99) 4), the applicant for a CEP can improve the quality of their dossiers and therefore limit
requests for additional information and the time taken