The revised EDQM guideline “content of the dossier” and other key documents will be useful tools
With effect from May 1, 2024, the updated EDQM guideline “Content of the dossier for chemical purity and microbiological quality of substances for pharmaceutical use” is now accessible. The usage of EMA SPOR/OMS ORG_ID and LOC_ID, along with this guidance and other important papers (QOS, top ten defects), are crucial to preventing the blocking of a CEP dossier upon receipt or in response to requests for further information.
This amended guideline’s changes were made with the intention of bringing requirements into line with the current regulatory landscape (the previous version of this document was put into effect in January 2019). The guidelines have been revised, in particular, with reference to specific details that must be included in the three modules of the submission—which are explained below.
Use of the proper EMA SPOR/OMS ORG_ID and LOC_ID for the CEP holder and manufacturing sites, as well as the completion of the declarations provided in the application form’s annex, should be given special consideration in Module 1.
Revised template is now available for the Quality Overall Summary (QOS), which is Module 2. It functions as a succinct synopsis of Module 3, emphasizing the control approach used and the ways in which regulatory criteria are satisfied to guarantee the substance’s quality. It also gives assessors a comprehensive grasp of the substance’s specifications and production process. The QOS is an essential part of the CEP application and needs to be completed in accordance with Module 3 and with the utmost priority. A badly written or inadequate QOS might cause problems and delays in the assessment process, which could endanger the timetable for obtaining a CEP in its whole.
New requirements for CEP 2.0, encouragement to apply for a re-test period with the option to refer to all ICH climatic zones, and the implementation of Post-Approval Change Management Protocol(s) are just a few examples of the improvements made to Module 3.
Detailed expectations for sections pertaining to the manufacturing process, beginning materials, and intermediates that facilitate comprehension of the suggested control approach are among the other noteworthy modifications. The requirement to create a thorough risk assessment that is based on ICH M7 and considers the possibility of nitrosamine production and carryover has been added. There are several changes surrounding the submission of applications for sterile active ingredient; however, separate EDQM advice will address these.
By providing further information on certain Module 3 items, the EDQM publication “Top ten deficiencies in New Applications for Certificates of Suitability for Chemical Purity” aids applicants in avoiding shortcomings.
In order to facilitate the expeditious processing of CEP applications, the EDQM will enforce a more stringent application validation process upon receipt, verifying that the submission complies with the specifications outlined in the updated guidelines and QOS template. Therefore, in the event that an application is deemed insufficient to begin the assessment process, the EDQM may reject it upon receipt beginning in May 2024.
The applicants are therefore strongly advised to prepare their CEP applications in accordance with the updated guidelines and the relevant key documents:
EDQM policy “Content of the dossier for substances intended for pharmaceutical use that are microbiologically and chemically pure”
· QOS model
· The top 10 flaws in newly submitted applications for chemical purity certificates of suitability
· Guidelines for using SPOR Id information
For more update stay tuned with us.
Email us : nr@ectdsubmission.com
