To be implemented on March 1, 2009: Are you prepared?
Moderated By Eyal Rivlin (Teva-KS)
Lev Hakongressim, Weizmann
Science Park, Ness Ziona
Monday May 5, 16:00h
GMP Annex 1 has been revised and updated in four main areas:
- Classification table for environmental cleanliness of clean rooms
- Guidance on media simulations
- Guidance on bioburden monitoring
- Guidance on capping of freeze-dried vials
The new annex will be implemented by 01 March 2009 and on this occasion, Israel PDA Chapter organizes a discussion forum about the impact of the new updates on the manufacture of sterile medicinal products.
