EDQM revises guideline for Content of Dossier for CEPs for improving Quality of dossier.

The revised EDQM guideline “Content of the dossier for chemical purity and microbiological quality of substances for pharmaceutical use” will be effective from 1st May 2024. The  key updates are with regards to   information to be included in the Module 3 – detailed expectations for sections related to the manufacturing process, starting materials and intermediates, comprehensive risk assessment of nitrosamines and encouragement to apply for a re-test period for the substance.

The guideline and associated updates Updated Template for QOS (Module 2) and revised policy document for identifying the manufacturing sites linked to CEP (holder and manufacturing site) by the SPOR OMS coordinates helps avoid a CEP dossier being blocked at receipt or receiving requests for additional information. In Module 1 particular attention should be paid to use the appropriate EMA SPOR/OMS ORG_ID and LOC_ID for the CEP holder and manufacturing sites. The template for Module 2, Quality Overall Summary (QOS) is updated with focus on highlighting the control strategy for providing clear understanding of the substance’s specification and manufacturing process.

The EDQM document discussing Top Ten Deficiencies in CEP applications provides useful insights for applicants to avoid deficiencies leading to rejection of CEP application or requests for additional information.  The top 10 deficiencies include poor description or deficient discussion of manufacturing process; inadequate  specification for intermediates, starting materials, raw materials, recovered materials; reprocessing and recovery of materials, risk assessment for Nitrosamines, related substances, residual solvents, identification of starting materials.

Lifecycle Management in CEPs is another important aspect applicants should manage efficiently. For Change notifications, to facilitate the acceptance of proposed changes in a timely manner, ensure the appropriate conditions for different notifications are fulfilled as per Guideline on requirements for revision/renewal of Certificates of Suitability to the European Pharmacopoeia Monographs (PA/PH/CEP (04) 2, 7R corr). Any change not classified as a notification or a major change should be classified as a minor change by default. Any submission of a notification with changes not classifiable as a notification will be rejected and will need to be resubmitted