Published: March 2026 | 332 Pages | Available from ISPE
The pharmaceutical and life sciences industries are changing rapidly — and the systems that control our manufacturing
processes must change with them. That’s why ISPE is proud to announce the publication of the
GAMP® Good Practice Guide: GxP Process Control Systems, Third Edition, the definitive resource for
organizations seeking to design, implement, and maintain Process Control Systems (PCSs) that are both fit for intended
use and fully compliant with current regulations.
Built on a Foundation of Trusted GAMP Guidance
This third edition is fully aligned with the broader GAMP ecosystem, including
GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Second Edition),
the GAMP® RDI Good Practice Guide: Data Integrity – Manufacturing Records, and the
GAMP® Good Practice Guide: Enabling Innovation. Together, these references form a coherent,
risk-based framework that organizations can rely on across their entire technology portfolio.
Addressing Today’s Technology Landscape
Perhaps the most significant update in this edition is its direct engagement with the technologies transforming modern
manufacturing. The Guide provides practical, compliant guidance on:
- Cloud and SaaS integration into regulated manufacturing environments
- Artificial intelligence applications within Process Control Systems
- Modular plant design and the flexibility it demands from PCS architecture
- Operational technology (OT) cybersecurity — an increasingly critical concern
- Software development tools and modern engineering methodologies
The Guide also embraces forward-looking methodologies such as Pharma 4.0™, continuous
manufacturing, medical device production, and personalized medicine — recognizing that the manufacturing landscape of
tomorrow requires guidance that goes beyond traditional batch production.
A More Holistic Roadmap: From Design to Operation
One of the standout enhancements in this edition is a strengthened connection between Process Control Systems and the
process equipment activities defined in the ISPE Baseline® Guide: Commissioning and Qualification (Second Edition).
By aligning these two bodies of guidance more closely, the Guide provides a streamlined, end-to-end roadmap that helps
organizations move efficiently from initial design through full operational qualification — reducing duplication of
effort and minimizing compliance risk along the way.
Key Benefits for Organizations and Suppliers
Whether you are a manufacturer, technology supplier, or systems integrator, this Guide is designed to help you:
- Reduce risk throughout the PCS lifecycle
- Accelerate implementation timelines without sacrificing compliance
- Improve data integrity across manufacturing records and control systems
- Unlock new efficiencies through smarter, more resilient system design
- Achieve cost-effective compliance in a rapidly evolving regulatory environment
Accessibility and Special Pricing
ISPE is committed to making this guidance accessible to organizations around the world. Special pricing is available
for companies based in Emerging Economies, reflecting ISPE’s mission to support global adoption of best practices in
pharmaceutical manufacturing.
The GAMP® Good Practice Guide: GxP Process Control Systems, Third Edition (332 pages) is available now
via the ISPE website. Visit ispe.org to learn more, view the Table of Contents, and place your order.
