EDQM: Top Ten Deficiencies for CEPs

In February 2024, the EDQM (European Directorate for the Quality of Medicines & HealthCare) has published its summary of the top ten deficiencies which occurred during the evaluations of the CEPs in 2023. This document called "TOP TEN DEFICIENCIES in New Applications for Certificates of Suitability for chemical purity" should help applicants to avoid such deficiencies in future and lists in detail the findings and its respective sections. In addition, it is recommended to use the EDQM guideline "Content of the dossier for chemical purity and microbiological quality", which was implemented in January 2019, for compiling the CEP dossiers.

According to the summary, still the topics starting materials (Top 4, Top 10) and impurities (Top 3, Top 7, Top 8, Top 9) including Nitrosamines caused the most findings. In the following five findings out of the top ten deficiencies are mentioned accordingly:

TOP 1: 3.2.S.2.2

Lack of details and/or poor description of the manufacturing process of the substance from the introduction of starting materials (This includes discrepancies noted between the information given in sections S.2.3 and S.2.4). (raised 12% of all questions)

TOP 2: 3.2.S.2.4 and TOP 4: 3.2.S.2.3

Non-adequate or poorly justified specifications proposed to control the quality of isolated intermediates (raised 11% of all questions) and starting materials (raised 7% of all questions).

TOP 3: 3.2.S.3.2

Absence or deficient discussion on the risk of having potential mutagenic impurities in the final substance. (raised 7.5% of all questions)

TOP 5: 3.2.S.2.3

Absence or inadequate acceptance criteria (and/or analytical methods) for raw materials (incl. recovered materials) used in the manufacture of the final substance, from the introduction of starting materials. (raised 7.1% of all questions)

All remaining deficiencies and their detailed description are mentioned in the document "TOP TEN DEFICIENCIES in New Applications for Certificates of Suitability for chemical purity". Further information for compiling CEP dossiers is provided on the webpage of EDQM.

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