CRED Getting the CMC Dossier Right 2024

28/08/2024

Due-Diligence Tips - CEP

• Applicants should check if a re-test date has been included in the CEP and if not request the corresponding stability data from the supplier. • Check for TSE certification, i.e. has this been included in the CEP if not is a declaration required? • Has an update to the CEP been issued, which should be submitted instead? • KNOWLEDGE Database - European Directorate for the Quality of Medicines & HealthCare (edqm.eu) • Are there any analytical method and specifications included as conditions of the CEP?

The Organisation for Professionals in Regulatory Affairs

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Due-Diligence Tips - ASMF

• Is the document consistent across all sections?

• Does the ASMF include all the data required as stated in relevant ICH guidelines?

• Are there discrepancies between the applicant’s part and the ASMF. Is the same re -test date being quoted? Are any additional tests being done by the applicant?

• Is there any further processing of the API after it is obtained from the supplier?

• Has the relevant data been included in the applicant’s part?

• Was stability performed in the Container Closure System as it is to be supplied?

• In the case of different API suppliers, is a common spec being used or are different specifications and methods being used?

The Organisation for Professionals in Regulatory Affairs

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