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Published: November 2011 Pages: Part 1 - 188, Part 2 - 232 Part 1 Table of Contents ( 519 KB) Part 2 Table of Contents ( 436 KB)

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Part 1 includes the topics of Criticality, Design Space, and Control Strategy and addresses product and process development, transfer to, and establishment of, commercial manufacture using science- and risk-based approaches.

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

• Download Addendum to Table 4.22 ( 207 KB)

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