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EMA released the Guideline on the sterilisation of the medicinal product, active substance, excipient and primary container on 6 March 2019, and it will go into effect 1 October 2019.
The guideline is available here.
This document addresses:
4. General requirements
4.1. Requirements for the manufacture of sterile medicinal products and sterile components
4.1.1. Steam sterilisation
4.1.2. Dry heat sterilisation
4.1.3. Ionization radiation sterilisation
4.1.4. Gas sterilisation
4.1.5. Sterile filtration
4.1.6. Aseptic processing
4.2. Good manufacturing practice for sterile active substances, sterile Excipients and sterile containers 4.2.1. Active substances
4.2.2. Excipients
4.2.3. Containers
4.3. Selection of sterilisation method
5. Decision trees
If you are working in a facility/ product line subject to EMA then you need to be aware of this guide and potential changes in the regulatory requirements.
