ISPE Guide Series: Product Quality Lifecycle Implementation (PQLI®) from Concept to Continual Improvement (Part 2 – Product Realization using Quality by Design (QbD): Illustrative Example)

 
9781936379217: ISPE Guide Series: Product Quality Lifecycle Implementation (PQLI®) from Concept to Continual Improvement (Part 2 – Product Realization using Quality by Design (QbD): Illustrative Example)

Part 2 presents the small molecule case study developed by the ISPE PQLI teams. This case study provides details of the application of the approaches to product and process understanding using quality risk management. Part 2 also refers to the many case studies in the public domain and uses ICH guidelines Q8 (R2), Q9, Q10, together with other relevant ICH guidelines.

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ISPE
Published by ISPE (2011)
ISBN 10: 193637921X ISBN 13: 9781936379217
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