The International Society of Pharmaceutical Engineers has reported the first findings of a five-year new programme aimed at working tackling one of the toughest problems in pharma manufacturing at present - how to implement the new quality systems model laid out by the International Conference on Harmonization.
The first fruits of that programme, published in the June edition of the Journal of Pharmaceutical Innovation, represent a preliminary stage in attempting to provide practical guidance on how to implement these concepts into pharmaceutical processes.
Dubbed the Product Quality Lifecycle Implementation (PQLI), it was designed by ISPE as an initiative to help pharmaceutical manufacturers meet the requirements of ICH Q8, Q9 and Q10 in a way that would be acceptable to regulatory authorities.
link to full article
Showing posts with label ISPE. Show all posts
Showing posts with label ISPE. Show all posts
Monday, June 02, 2008
ISPE says quality programme starts to bear fruit
Tuesday, March 25, 2008
Join us for Breakfast
ISPE Joint Chapter Breakfast at Interphex
Who: Delaware Valley, New Jersey, and Great Lakes Chapters of ISPE
What: Breakfast Meeting and Presentation
Where: Philadelphia Marriott
When: 27Mar08- 7-9 am
Why: because you get up really early in the morning when you sleep in a hotel
The topic will be an Overview on Sustainable Design and LEED presented by Terry Jacobs, and How Does LEED Affect Your Project from the CM Perspective presented by Rick Warhall and Jonathan Hess of Whiting Turner.
Registration
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