Description
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.
Product Details
- Published:
- 11/01/2011
- ISBN(s):
- 9781936379231
- Number of Pages:
- 232
- File Size:
- 1 file , 15 MB
