GAMP5

GAMP5 (Good Automated Manufacturing Practice Guide: A Risk-Based Approach to Compliant GxP Computerized Systems), Fifth Edition, is a guidance document published by the International Society for Pharmaceutical Engineering (ISPE). It provides a risk-based framework for the life-cycle governance and validation of computerized systems used in GMP-regulated industries, including pharmaceuticals and biopharmaceuticals. The guide emphasizes proportionate validation efforts and supports the use of vendor-supplied software and cloud-based solutions through appropriate risk assessment and supplier controls.

Core concepts include a life-cycle approach that spans planning, user requirements, functional and design specifications, build, testing, deployment, operation, maintenance, and retirement. GAMP5 advocates tailoring deliverables to risk and complexity, aligns testing with design and requirements, and uses a V-model style of development. It also provides guidance on documentation, change control, configuration management, and qualification activities (such as installation, operational, and performance qualification).

Software categorization: GAMP5 defines categories to help determine validation effort, ranging from infrastructure and non-GxP software to configurable, custom-developed, and software-as-a-service or cloud-based solutions. The framework supports evaluating suppliers and managing risk across the supply chain, including vendor audits and procurement controls.

Impact and scope: GAMP5 is widely used in pharmaceutical, biotechnology, and related regulated industries and is cited in regulatory discussions as a practical approach to GMP-compliant computerized systems. It is intended as guidance rather than a strict standard and continues to influence how organizations implement, validate, and maintain computerized systems in a regulated environment.