In February the EDQM published a document with the top 10 deficiencies observed in new applications for a CEP for chemical purity, based on a random sample of 30 deficiency letters selected from the year 2023. This document is a follow-up of a similar document published in 2016.
Its purpose is to assist applicants in avoiding common issues during their submission. Deficiencies encompass various areas such as insufficient details in manufacturing processes, inadequacies in specifications for intermediates and starting materials, and deficiencies in discussions regarding mutagenic impurities, nitrosamines, related substances, residual solvents, and starting materials.
Each deficiency is accompanied by detailed explanations and specific points to further guide applicants, emphasizing the importance of adhering to relevant guidelines outlined in the EDQM guideline “Content of the Dossier for Chemical Purity and Microbiological Quality of Substances for Pharmaceutical Use.”
By addressing these deficiencies effectively, applicants can streamline the application process and improve the likelihood of successful certification, ultimately contributing to the quality and safety of pharmaceutical substances.
In case you want further guidance or would like to have your draft CEP dossier reviewed for GAPS before submission, please contact us for any assistance.