PQLI Key Topics - Criticality, Design Space, and Control Strategy |
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| Authors: | Thomas Garcia Graham Cook Roger Nosal |
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| Affiliation: | (1) Pfizer Inc., Eastern Point Rd., Groton, CT 06340, USA;(2) Wyeth Pharmaceuticals, New Lane, Havant, PO9 2NG, UK |
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| Abstract: | 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. |
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| Keywords: | PQLI Design space Criticality Control strategy Critical quality attribute Critical process parameter Knowledge space PAT Pharmaceutical target product profile Product and process knowledge Quality by design Quality risk management |
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