Page History

Answer:

An applicant can ask apply for a CEP specifying the grade sterile in its subtitlethat will carry the subtitle ‘sterile’. In this case, the dossier must include a detailed description of the sterilisation process as well as validation data shall be provided in the dossier. The specifications shall must of course include the sterility test as described in the general monograph "substances Substances for pharmaceutical use "(2034). The CEP will also specify the sterilisation method used and will refer to the test for sterility. The manufacturing site will be inspected before or after granting of the CEP (at the latest 18 months after granting the CEP is granted).

If both sterile and non-sterile substances are produced, separate dossiers shall must be submitted and separate certificates will be granted. 

Note Please note that validation data can be requested by licensing authorities in for the context purpose of the assessing a marketing authorisation application evaluation.

For more information on applications for CEPs for sterile substances, please see Clarification on the acceptability of CEP Applications for Sterile Grade Material PA/PH/CEP (08) 60, 1 R. You can download this document from the Certification Policy Documents & Guidelines webpage (‘Scope’ section).