Enhanced and accelerated regulatory pathways for “Breakthrough Therapies (United States) and “PRIME” medicines (European Union) have been introduced to provide faster access to exciting new therapies developed to treat unmet medical needs.1,2 Jokura et...
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.
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.
If you are involved in a PAT project, or are simply interested in learning more about PAT, this two-part webinar series provides you with an understanding of the fundamental aspects. This first webinar summarizes reasons...
Topics that are new to PQLI will be introduced as the project expands to understand how the ICH Quality Vision can be implemented globally. Challenges that companies face introducing or adapting change management and...
This online course provides the background for the origins of the ICH guidelines, Q8(R2), Q9, Q10 and Q11. It covers development and manufacture of drug substances (chemical entities and biotechnological/biological...
Published: November 2011 Pages: 188 Table of Contents Special Pricing for Emerging Economies Part 1 includes the topics of Criticality, Design Space, and Control Strategy and addresses product and process development, transfer to, and establishment
Published: November 2011 Pages: 232 Table of Contents Special Pricing for Emerging Economies 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
ISPE’s Product Quality Lifecycle Implementation (PQLI®) initiative was created to provide guidance on practical implementation of the concepts described in ICH guidelines, focusing on Q8, Q9, Q10 and the future Q11 to...
