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A Certificate of Suitability (CEP) certifies the Active Pharmaceutical Ingredients (APIs) manufacturing companies’ edge in demonstrating quality, safety, and efficacy to the Regulatory authorities. A CEP is a publicly available certificate issued by the European Directorate for the Quality of Medicines (EDQM).
Role of the EDQM
The EDQM is responsible for controlling the quality of medicines in Europe. The following are the benefits of receiving a CEP certification from the EDQM:
- Compliance with International Regulations: An EDQM certification ensures that the pharmaceutical product meets the International Council for Harmonization (ICH) regulations.
- Access to Global Markets: An EDQM certification is recognized globally and can help pharmaceutical companies access new markets.
- Improved Supply Chain Management: The EDQM’s CEP certification requires a thorough review of the manufacturing process, quality control, and product testing, which can help improve supply chain management and reduce the risk to API in terms of quality.
- Enhanced Reputation: An EDQM certification is a mark of quality and enhances the reputation of the pharmaceutical firm.
- Continued Support: The EDQM guidelines and notifications provide ongoing support to certified companies in the form of Regulatory updates and guidance on Quality Management Systems (QMS).
Understanding the CEPs through EDQM’s perspective
The demand for CEPs has increased as pharmaceutical companies increasingly want to demonstrate their API quality to regulators, leaving an opportunity to upgrade their ASMFs to CEPs. Moreover, this transition can make the review process of regulators swifter. The EDQM website has a unique system of updating stakeholders through a monthly reporting system, a summary of which is provided below.
Comprehending EDQM Reports from August 2022 to February 2023
Table 1 below details the month-wise CEP approval criteria with percentage differences throughout the discussed period.
Table 1: Data Excerpts from the Monthly Certification Reports by the EDQM
SlNo. | CEP Criteria | Year – 2022 | Year – 2023 | ||||||
CEP Status | Aug | Sept | Oct | Nov | Dec | Jan | Feb | ||
1. | New CEPs Granted | Chemical CEP | 28 | 30 | 45 | 44 | 40 | 45 | 29 |
2. | CEP Revisions Approved |
| 153 93
| 125 61 | 123 65 | 99 63 | 95 43 | 166 88 | 130 88 |
3. | Approval Rate (%) |
| 85.4% 9.6% | 93.1% 0.0% | 90.1% 0.0% | 94.9% 0% | 99.3% 7.1% | 99.6% 5% | - - |
4. | Inspection Program |
| 1 2 2 | 3 0 1 | 4 0 0 | 5 0 3 | 1 0 1 | Nil Nil Nil | 2 1 4 |
5. | Actions on CEP |
| 0 0 0 6 2 | 0 0 0 4 4 | 0 0 0 12 1 | 13 0 0 11 3 | 0 0 0 1 0 | 0 0 0 3 1 | 0 0 0 17 3 |
Source: An excerpt from EDQM’s monthly report of activities
- The observations from the data excerpts in the above table are listed below: Newly granted CEPs show a steady trend, indicating the API manufacturers’ competencies in terms of adhering to the Regulatory requirements for quality CEP.
- The approval rates for new dossiers have been very low in most months, which suggests that getting new dossiers approved with the Right First Time (RFT) strategy is quite challenging, either due to the lack of a clear understanding of HA requirements or the lack of relevant in-house expertise.
A seasoned Chemistry, Manufacturing, and Controls (CMC) Regulatory Affairs partner with expertise in compilation, review, and submission can enable you to file your CEP submissions with the RFT approach. Freyr is a preferred Regulatory partner that helps API manufacturers across the globe with their CEP submissions. Explore our expertise in CEP submissions to ensure seamless and compliant requests!
