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Europe
EU GMP Annex 1 : new version: It
has been confirmed that the implementation date for the Annex 1
capping requirement for all aseptically-filled materials (not only
freeze-dried) is 1st March 2010. The 'freeze-dried' reference in the
first page note is a mis-print.
PDA-ISPE-PIC/S conference: A
conference on interpretation of the new Annex 1 requirements from a
PIC/S perspective is to be held in Geneva, Switzerland in November
2008. The conference is open to
regulators and industry and will also focus on ongoing liaison and
improvement of communication between regulators and industry. |
Martyn
Becker Associates Global GMP consultants aseptics and steriles specialist
GMP consultancy. Good Manufacturing Practice standards for the
pharmaceutical industry systems.