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.
By establishing a PP&PQMS, your company can improve opportunities to:
The Guide introduces the role of Quality Steward as an owner of product quality. Responsibilities of the role are discussed for this new concept emerging from industry
This PQLI Guide is relevant for: