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

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 …

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 …

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 …

Mar 5, 2025 · Conclusion GAMP guidance is essential for ensuring the quality, safety, and compliance of pharmaceutical products. By adhering to GAMP guidance and participating in …

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 …

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

Jul 24, 2025 · The new ISPE GAMP® Guide: Artificial Intelligence provides a comprehensive, state-of-the-art best practice framework to efficiently and effectively achieve high-quality AI …