GAMP Good Practice Guide: GxP Process Control Systems 3rd Edition.

Published: March 2026
Pages: 332

• Table of Contents
• Special Pricing for Emerging Economies

This third edition delivers a powerful, forward-looking update designed to help organizations confidently navigate the rapidly evolving manufacturing and technology landscape. Fully aligned with ISPE GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Second Edition), ISPE GAMP® RDI Good Practice Guide: Data Integrity – Manufacturing Records, and ISPE GAMP® Good Practice Guide: Enabling Innovation, this Guide equips organizations with the bestpractice strategies to help them achieve Process Control Systems (PCSs) fit for intended use and compliant with regulations in a cost-effective manner.

Building on the foundations of trusted GAMP guidance, the ISPE GAMP Good Practice Guide: GxP Process Control Systems (Third Edition) addresses technology advances in modular plant design, cloud and SaaS integration, software development tools, artificial intelligence, and operational technology cybersecurity. The Guide also embraces methodologies such as Pharma 4.0™, continuous manufacturing, medical device production, and personalized medicine.

In addition, the Guide strengthens the connection between PCSs and the process equipment activities defined in the ISPE Baseline^® Guide: Commissioning and Qualification (Second Edition)—providing a more holistic, streamlined roadmap from design to operation.

Together, these enhancements empower companies and suppliers to reduce risk, accelerate implementation, improve data integrity, and unlock new efficiencies—delivering smarter, more resilient, and futureready PCSs.

Guide Core Team

Karen Ashworth

Director

Karen Ashworth Consulting Ltd

Hilary Mills-Baker

Chair of the UK GAMP Community of Practice

Retired

Reetu Chopra

Senior Manager

ProductLife Group

Eric Collier

Assistant Director of Automation and IT/OT

CAI

Gráinne Coyne

Principal Software Quality Assurance Engineer

Boston Scientific

Victor De Oliveira Silva Ferreira

EQMS Project Manager

Instituto De Tecnologia Em Imunobiológico/Fundação Oswaldo Cruz

Thomas Makait

Managing Director

MTP4Pharma® - Plug & Produce for Smart Manufacturing - Intrinsic Quality & Compliance

David Margetts

CEO

Factorytalk Co., Ltd.

Stefan Münch

Vice President Validation & Qualification

Körber Pharma Consulting GmbH

Bart Reijs

Director

Tenthpin Management Consultants

Gregory Ruklic

Sys. Compliance Professional

Independent Consultant

Imge Yilmaz

Senior Validation Specialist

Qiagen

For the full list of contributors to this Guide see Guidance Document Teams