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.
Document identifier
ISPE Guide Series: Product Quality Lifecycle Implementation (PQLI) from Concept to Continual Improvement Part 2 - Product Realization using QbD, Illustrative Example
ISPE Category
PQLI Guides
Publication date
2011-11-01
International Relationship
| Price |
460 vnd |
.jpg){kind=logo}
---Logo.jpg){kind=logo}
.jpg){kind=logo}
-_-logo.png){kind=logo}
.jpg){kind=logo}
.png)
