ISPE Guide Series: Product Quality Lifecycle Implementation (PQLI) from Concept to Continual Improvement Part 4 – Process Performance and Product Quality Monitoring System PDF

The ICH Q10 guideline, Pharmaceutical Quality System, states that a process performance and product quality monitoring system (PP&PQMS) should be planned and executed to ensure that process performance and product quality are maintained in a state of control. The objective of this guide is to provide “how to” guidance for establishing and implementing a PP&PQMS in line with the expectations of the ICH Q10 guideline.

Part 4 of the ISPE PQLI Guide series, PP&PQMS, considers process performance and product quality monitoring systems established to support products and processes developed using the enhanced, Quality by Design (QbD) approach discussed in ICH guidelines ICH Q8(R2), ICH Q9 and ICH Q11.