GAMP® Guidance Documents Good Automated Manufacturing Practice (GAMP®), is a technical sub-committee of the International Society for Pharmaceutical Engineering (ISPE). The goal of this …

Sep 25, 2025 · The ISPE GAMP® 5 Guide: A Risk-Based Approach to Compliant GxP Computerized Systems Second Edition aims to protect patient safety, product quality, and data integrity by …

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 …

The GAMP® Good Practice Guide: A Risk-Based Approach to Calibration Management (Second Edition) provides guidance in setting up a calibration management system, which will give a …

ISPE’s GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Second Edition) (GAMP® 5 Guide, 2nd Edition) maintains the principles and framework of the first edition and …

Aug 16, 2022 · GAMP® 5 Second Edition is here! Since its publication, GAMP® 5 has been far and away the leading international guidance on GxP computerized systems validation and compliance, …

Mar 5, 2025 · Why GAMP ® Matters GAMP is crucial for several reasons. Firstly, to ensure product quality and safety. Computerized systems play a critical role in the development, production, …

GAMP ® guidance aims to safeguard patient safety, product quality, and data integrity in the use of GxP computerized systems. It aims to achieve computerized systems that are fit for intended use and …

The GAMP ® Essentials certificate program, focused on good manufacturing practices (GMPs), provides helpful information for anyone in the industry involved in computerized systems compliance. The …

Conclusion GAMP guidance makes a valuable distinction between GxP records supporting the medical product life cycle and required by a predicate rule, and non-GxP information, data, and artifacts that …