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Advantages and Challenges for the Pharmaceutical Industry of Upgraded Guidelines for Aseptic Process (Annex 1)|Outline:
- Major changes in Annex for aseptic Drug Product and other operations
- Considerations for new sites
- Upgrades potentially needed for existing operations.
- Potential positive impact on supply reliability.
- Implementation ideas without lengthy shut-downs.
- Assurance that pharmaceuticals produced for rare diseases with small batch sizes stay viable products
- Learnings from the guidance to implementation on site
- Overall increased focus and opportunity on patient safety