Answer:
An applicant can ask for a CEP specifying the grade sterile in its subtitle. In this case detailed description of the sterilisation process as well as validation data shall be provided in the dossier. The specifications shall of course include the sterility test as described in the general monograph "substances for pharmaceutical use". 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).
If both sterile and non-sterile substances are produced separate dossiers shall be submitted and separate certificates will be granted.
Note that validation data can be requested by licensing authorities in the context of the marketing authorisation application evaluation.
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