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EU24CEMAR1/SESP10 - Advantages and Challenges for the Pharmaceutical Industry of Upgraded Guidelines for Aseptic Process (Annex1)


‐ Mar 13, 2024 9:50am

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