EMA has published a new Guidance on the sterilization of the medicinal product, active substance, excipient and primary container.
The purpose of this document is to provide guidance on the selection of appropriate sterilization methods for sterile products. In general, terminal sterilization according to the European Pharmacopoeia (Ph. Eur.) should be the method of choice. However, if it is necessary to use other terminal sterilization methods, sterilization filtration or aseptic processing (either alone or when combined with an additional post-aseptic processing terminal heat treatment); this Directive provides the necessary information. This includes the required documentation for sterile finished products, but also for sterile active ingredients and excipients and sterile primary packaging.
See Guideline in this link: