EDQM: TOP 10 Deficiencies in New CEP Applications
The European Directorate for the Quality of Medicines and HealthCare (EDQM) has published the top 10 deficiencies identified in 2023 following the initial evaluation of new applications for Certificates of Suitability (CEP).
The TOP 1 deficiency was a lack of detail and/or poor description of the manufacturing process of the substance from the introduction of starting materials (12%).
The TOP 2 deficiency relates to inadequate or poorly justified specifications proposed to control the quality of isolated intermediates (11%) and starting materials (7%).
Other deficiencies include the absence or inadequacy of risk discussions on mutagenic impurities, nitrosamines and residual solvents and the absence or inadequacy of acceptance criteria for raw materials.
This document is intended to help applicants avoid such problems. 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.
Source:
EDQM: Newsroom
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