Published: November 2011
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 (Adobe PDF 207 KB)