Read the top 10 deficiencies observed in new CEP applications for chemical purity assessed in 2023 to improve the quality of your applications!
This document is a summary of the top ten deficiencies identified after the initial evaluation of new applications for Certificates of Suitability (CEP) for chemical purity.
The content of this document is intended to help applicants to build their application in conjunction with the EDQM guideline “Content of the Dossier for Chemical Purity and Microbiological Quality of Substances for Pharmaceutical Use”. The deficiencies are listed and details on how to avoid them are provided for the users as a help to improve the quality of their applications.
This document is a summary of the top ten deficiencies identified after the initial evaluation of new applications for Certificates of Suitability (CEP) for chemical purity. It is based on the content of a random sample of 30 deficiency letters selected from the year 2023.
During this period the failure of applicants to satisfactorily address some of the deficiencies described below in their application resulted in an increase in the number of questions raised during requests for additional information by EDQM along with their complexity.
Consequently, the timeline for granting of the certificate of suitability was increased.
This document is intended to help applicants avoid such issues. Expanded details on specific points from each deficiency are provided to inform the users but should always be considered in conjunction with the EDQM guideline “Content of the Dossier for Chemical Purity and Microbiological Quality of Substances for Pharmaceutical Use” which outlines the specific requirements for the submission of CEP applications.
To continue reading this article please go to EDQM .