PQLI

Product Quality Implementation Lifecycle (PQLI) Guides provide information on global solutions to implementation challenges of International Council for Harmonisation (ICH) guidances.

Language
English
Guidance Docs
The ISPE PQLI Guide: Part 3 – Change Management System as a Key Element of a Pharmaceutical Quality System, is the only change management guide written expressly for the pharmaceutical industry. It provides practical, real-world strategies for implementing the change management recommendations of ICH Q10. The Guide contains information to help translate the holistic approach described in Q10 into an actionable plan and can help companies update and improve their change management practices.
Guidance Docs
The ISPE PQLI® Guide: Part 4 – Process Performance and Product Quality Monitoring System serves as practical how-to guidance with examples of technical and scientific methodology for adopting a process performance and product quality monitoring system (PP&PQMS) in line with the expectations of ICH Q10, Pharmaceutical Quality System.
Guidance Docs
Published: November 2011 Pages: 188 Table of Contents Special Pricing for Emerging Economies Product Realization using QbD: Concepts and Principles (PQLI® Guide Part 1) includes the topics of Criticality, Design Space, and Control Strategy and
Guidance Docs
Published: November 2011 Pages: 232 Table of Contents Special Pricing for Emerging Economies Product Realization using QbD: Illustrative Example (PQLI® Guide Part 2) presents the small molecule case study developed by the ISPE PQLI® teams. This case