Provide PDF Format
ISPE Guide Series: Product Quality Lifecycle Implementation (PQLI) from Concept to Continual Improvement Part 2 - Product Realization using QbD, Illustrative Example
- Secure PDF Files
- Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 11/01/2011
- Publisher: ISPE
$225.00$450.00
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.
Related Products
ISPE Baseline Guide: Volume 3 - Sterile Product Manufacturing Facilities, Second Edition
Secure PDF Files..
$253.00 $505.00
ISPE GAMP Good Practice Guide: A Risk-Based Approach to Operation of GxP Computerized Systems - A Companion Volume to GAMP 5
Secure PDF Files..
$225.00 $450.00
