ISPE Guide Series: Product Quality Lifecycle Implementation (PQLI) from Concept to Continual Improvement Part 2 – Product Realization using 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.

Published:

11/01/2011

ISBN(s):

9781936379231

Number of Pages:

232

File Size:

1 file , 15 MB

Note:

This product is unavailable in Russia, Belarus