Articles
PQLI Key Topics - Criticality, Design Space, And Control Strategy
April 15, 2009
•White Paper: PQLI Key Topics - Criticality, Design Space, And Control Strategy
By Thomas Garcia , Graham Cook and Roger Nosal
This paper gives an overview of progress made by the ISPE PQLI initiative - a global industry-led initiative aimed at facilitating the implementation of ICH Q8, Q9, and ultimately Q10 guidance. Through this initiative ISPE is spearheading the effort to help industry begin to define areas where they will be able to provide the technical framework for the implementation of key elements of Quality by Design (QbD) - a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding based on sound science and quality risk management. Three topic areas, Design Space, Criticality, and Control Strategy were selected for specific focus and discussion, and this paper gives an overview of progress in these three areas.
Click Here To Download:•White Paper: PQLI Key Topics - Criticality, Design Space, And Control Strategy
