The GMP basic requirements for active substances used as starting materials (EU GMP guideline part II) only applies to the manufacture of sterile active substances up to the point immediately prior to the active substance being rendered sterile. The sterilisation and aseptic processing of sterile active substances are not covered by this guideline and should be performed in accordance with GMP for medicinal products (Commission Directive 2003/94/EC as interpreted in the basic requirements for medicinal products including annex 1 of the EU GMP guideline part I). This implies that for any active-substance manufacturer that performs sterilisation and subsequent aseptic handling of the active substance, a valid manufacturing authorisation or GMP certificate an EEA authority or an authority of ries where MRA or other Community arrangements apply has to be submitted.
The active-substance manufacturer also has to submit data on the sterilisation process of the active substance (including validation data) to the marketing authorisation applicant or holder for inclusion in the dossier submitted for the finished product and approval by the licensing authorities.
