Content of the Dossier
Detailed information on what an application should contain is described in the documents below. Refer to the document relevant to your application.
- Content of the dossier for chemical purity and microbiological quality, PA/PH/CEP (04) 1, 6R
- Content of the Dossier for a Substance for TSE Risk Assessment (PA/PH/CEP (06) 2 1R)
- Content of the Dossier for Herbal Drugs and Herbal Drug Preparation Quality Evaluation PA/PH/CEP (02) 6 1R
- Top Ten Deficiencies in New Applications for Certificates of Suitability for Chemical Purity PA/PH/CEP (24) 10
Quality Overall Summary (QOS) template to be used:
- Template for Quality Overall Summary to be submitted for Certification applications (PA/PH/CEP (15) 26 1R, January 2024)
For applications related to sterile API, you should also read the:
Nitrosamine risk assessment (for chemical and Herbal applications)
Any application should include a risk assessment for the presence of nitrosamines based on the principles outlined in the ICH Q9 & ICH M7 guidelines. The risk evaluation should address not only risks from the manufacturing process but also those from the introduction of materials used in the manufacturing process (e.g. starting materials, reagents, solvents – fresh and recovered, etc.).
In the event that a risk of presence of nitrosamines is identified as a result of the risk evaluation, confirmatory testing should be carried out using appropriately validated and sensitive methods.
Where nitrosamine impurities have been detected, CEP holders should define appropriate specifications and introduce controls and if requested following the assessment might have to introduce amendments of the manufacturing to lower the presence of nitrosamine.
Search for a list of granted CEPs, their type, the name of the substance, the full CEP number, the issue date and validity status, using the Certification Database (updated daily).
Applicants commit to provide samples of substance and/or impurities when requested by the EDQM.