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 …

May 10, 2023 · 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 …

Jan 13, 2026 · 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 compliance, …

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 …

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 ISPE training events, …

GAMP® Data Integrity 21 CFR Part 11 2-Day Training Course (T70) The importance and amount of data being generated to ensure product quality and patient safety continues to grow, and proper controls …

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 …