The Process Performance and Product Quality Monitoring System (PPPQMS) is a fundamental element of the PQS described in ICH Q10. An effective PPPQMS ensures a state of control is maintained and facilitates continual improvement. The ISPE APQ Guide: PPPQMS provides a quality management framework for assessing and advancing an organization’s PPPQMS.

Maintaining the principles and framework of the First Edition, GAMP® 5 (Second Edition) is newly revised and expanded to address the increased importance of service providers, evolving approaches to software development, and the more widespread use of software tools and automation. It highlights the use of Critical Thinking by knowledgeable and experienced SMEs to define appropriate approaches.

The ISPE Good Practice Guide: Membrane-Based Water for Injection Systems provides expert guidance on the design, operation, maintenance, and quality aspects of membrane-based WFI systems, including generation, storage, and distribution. This Guide reflects an industry wide collaborative effort by a diverse range of industry experts that include equipment providers, engineering firms, consultants, and pharmaceutical manufacturers. The information presented in this guide is the combination of proven technological solutions, microbial control methods, process analytical technology, and operations and maintenance practices.