PQLI Guide: Part 4 - Process Performance & Product Quality Monitoring System


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Published: June 2013

Pages: 80

The ISPE PQLI® Guide: Part 4 – Process Performance and Product Quality Monitoring System provides 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:

  • Maintain compliance with global regulations
  • Improve confidence that a process runs as intended

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:

  • New and existing products
  • Small and large molecule
  • All phases of product lifecycle, from development through product discontinuation