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 ICH Q8, Q9, Q10, Q11 and Q12 to help ensure product quality throughout a product lifecycle, leading to continuous product improvement. The original project produced the ISPE PQLI® Guide Series.
Articles and Blogs
- PQLI: Advancing Innovation & Regulation
- PQLI Application of Science-and Sisk-based Approaches (ICHQ8,Q9,andQ10) to Existing Products
- PQLI Design Space
- PQLI Roadmap: Product Design, Development, and Realization, Science- and Risk-Approach to Implementation
Current PQLI Teams
Today, PQLI Technical Teams are developing solutions in emerging regulatory and scientific topics related to CMC and GMP approaches to ensuring product quality.