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, Q11 and Q12 to help ensure product quality throughout a product lifecycle, leading to continuous product improvement.
Today, PQLI Technical Teams are developing solutions in emerging regulatory and scientific topics related to CMC and GMP approaches to ensuring product quality.
– Continuous Manufacturing
– ICH Q12 Implementation
– Patient Centric Quality Standards
– Process Validation