All the regulatory documents or certifications are in place to make sure that the public/consumer health is protected. The CEP procedure contributes heavily to this area as well as regulatory efficiency and global harmonization. CEP is not mandatory. It is another way to show that the pharmaceutical substances are in compliance with European Pharmacopoeia standards. Although it isn't mandatory, let's get to know why it is important and more about CEP.
What Is Certification of Suitability (CEP)?
The Certification of Suitability (CEP) is an official certificate which confirms that the quality of the pharmaceutical substances (API & excipients) is in compliance with the monograph of the European Pharmacopoeia.
Manufacturers obtain CEP for the pharmaceutical substances that are covered under a monograph in the European Pharmacopoeia. The CEP is issued by the European Directorate for the Quality of Medicines and HealthCare (EDQM) whose mission is to contribute to the protection of public health.
Importance Of Certification Of Suitability
Manufacturers can prove that the quality of a substance satisfies the standards mentioned in the respective monograph of the European Pharmacopoeia (Ph. Eur.) using CEP certification. Obtaining a Certification of Suitability also means that the pharmaceutical substance is in compliance with current regulatory requirements. The CEP procedure allows for centralized assessment of the quality of the pharmaceutical substances which saves time and resources. Harmonization of the assessment of data is also achieved.
The Certification of Suitability can be used in many other countries as it is widely accepted in Ph. Eur. member states. Since the manufacturers must provide documentary evidence, it enhances the trust and confidence in public and healthcare providers. CEP provides an opportunity for health professionals and patients to be sure of the quality and safety of the active ingredients and other pharmaceutical substances used.
For the commercialization of active pharmaceutical ingredients in Europe, the CEP can serve as an important element. Since the Certification of Suitability is internationally recognized, it aids in the simplification of registration procedure. Moreover, the CEP can provide valuable information that can be used to update or in the revision of the monograph of Ph. Eur.
Types Of CEP
There are mainly 3 types of CEPs. They are
Chemical CEP: Certification of Suitability issued for chemical active pharmaceutical ingredients (API).
TSE CEP: Certification of Suitability issued for TSE (Transmissible Spongiform Encephalopathy) risk active pharmaceutical ingredient.
Herbal CEP: Certification of Suitability issued for herbal active pharmaceutical ingredients.
Apart from this, combined CEPs can also be issued which can be chemical + sterility, TSE + sterility or chemical + TSE+ sterility. Blood products, vaccines and such other biological substances are avoided from the CEP certification and hence they receive no CEP.
How To Apply For A CEP?
To get a CEP certification, the applicant must submit the electronic format of an application form, dossier in CTD format, modules 1, 2 and 3, written in English, detailed information about the API on chemical purity and microbiological quality as outlined in the PA/PH/CEP (04) 1, 7R and detailed information about sterile substances (if API is a sterile substance) as outlined in PA/PH/CEP (23) 54, November 2024. All these submissions are made to the DCEP (Certification of Substances Department) of EDQM.
After receiving the application, it is validated and then will be listed for assessment. Following the assessment, EDQM can request for additional information or raise queries upon any deficiencies to the applicant. The EDQM grants the CEP certification to the applicant if everything is resolved.
It takes 3 rounds of assessment for the evaluation of the application. Applications that fail to provide with all the sufficient information even after a maximum of 2 EDQM deficiency letters sent after the evaluation will be closed or rejected.
Upon receival of applications that are out of scope of the certification procedure will be rejected. This applies to the following:
Substances which are not in the Ph. Eur.
Biologicals
Derivatives of blood and human tissues, vaccines
Medicinal Products (Finished Pharmaceutical Products)
Sister CEP Submissions
Any applicant or company that holds a CEP may wish to apply for an another or a second CEP for the same active pharmaceutical ingredient due to either:
It is not possible to apply for the revision of the CEP or
The applicant might wish to have separate CEPs for alternate specifications (For example: to cover an alternative manufacturing process or manufacturing site, an alternate grade).
This new application is referred to as the sister CEP submissions or sister file. This procedure is intended to make the submissions of similar dossier within the certification procedure easier. The sister file procedure permits the applicant to benefit from a fast-track procedure and harmonized assessments. While assessing this type of dossier, the focus is on the differences stated in comparison to the approved CEP dossier.
The final decision to accept or to reject an application coming under sister file procedure is the responsibility of EDQM. If the application is rejected, the applicant is informed, and it gets transformed to a new dossier application. This will be then processed accordingly.
The following documents must be provided in electronic format while applying for a sister CEP submission.
A specific application which involves the invoicing details and a table comparing the difference between the new and existing CEP.
A complete dossier in the electronic Common technical format (eCTD).
A risk assessment regarding the potential for any nitrosamine impurities in the substance.
Sister CEP Submission Requirements
The sister CEP submission must fulfill the following conditions. They are: -
The substance must be the same as that mentioned in the CEP dossier referred to.
The EDQM must have already approved the CEP dossier that is being referred to, not only approved but also granted and is still valid must be the corresponding CEP.
Same should be the holder for both applications.
In normal cases the manufacturer of the final substance must be the same but, in any case, if the manufacturer is not the same for both applications, then the manufacturing process, impurity profile and in-process control must be the same as mentioned in the CEP dossier that is being referred to.
The concepts of Quality-by-design and PAT (Process Analytical Technology) can be included in the sister CEP submission only if it was previously approved in the CEP dossier that is being referred to.
To gain a CEP certificate it requires extensive documentation, compliance of manufacturing process and testing with the respective pharmacopoeian and regulatory standards. Here at Artixio, we have a team of professionals who are experienced in global markets and product commercialization. Partnering with us can help you overcome these challenges and help you in speeding up the process. Connect with us through info@artixio.com
FAQs About CEP
Q. How does a CEP simplify regulatory submissions?
A: Since CEP is widely accepted, if a manufacturer wishes to start another manufacturing site and already holds a CEP, the approval process will be faster. CEP certifies that pharmaceutical substances are in compliance with the Ph. Eur. standards which serves as a proof for safety of the substance to the regulatory without the need for a detailed review.
Q What challenges are commonly faced during CEP applications?
A: Common challenges being exhaustive documentation, failing to comply with the standards mentioned in the monograph of Ph. Eur., providing incomplete or inadequate data. All these may lead to a delayed approval or rejection of CEP.
Q How often must CEPs be renewed?
A: CEPs should be renewed once after five years of the issue date of the original CEP. This is done for it to remain valid. If any changes to the information provided in the initial application occur in this five-year period, it must be informed to EDQM.
Q What role does EDQM play in issuing CEPs?
A: Upon receival of the application for CEP, EDQM evaluates these applications and makes sure that they are in line with the standards stated in Ph. Eur. By carrying out this step it is convinced that the pharmaceutical substances are of quality.
Q Are CEPs accepted globally?
A: CEPs are recognized widely by regulatory bodies. The CEP procedure allows for a centralized and harmonized assessment.
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