Which GMPs to be applied for covering the sterilisation step of a substance?

The ICH Q7A note for guidance, included as Part II of Volume 4 (the Guidance on Good Manufacture Practices (GMP) for Active Substances used as Starting Materials) of the Rules Governing Medicinal Products in the EU, states in its introduction that it is applicable to the manufacturer of APIs for use in human (medicinal) products. It applies to the manufacture of sterile APIs only up to the points immediately prior to the APIs being rendered sterile. The sterilisation and aseptic processing of sterile APIs are not covered by this guidance, but should be performed in accordance with annex 1 of the EU GMP guidelines.