Product Quality Lifecycle Implementation® (PQLI®) from Concept to Continual Improvement
Part 2: Product Realization using QbD, Illustrative Example

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Published: November 2011
Pages: 232
Table of Contents ( 436 KB)

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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.

Part 2: Product Realization using QbD, Illustrative Example - Addendum to Table 4.22

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