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 …

4 days ago · 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 …

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, …

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 …

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 …

This ISPE GAMP ® Guide: Artificial Intelligence is the single source for a holistic interpretation on effectively developing and using AI-enabled computerized systems in GxP areas, while safeguarding …

Fundamental Principles of Compliance for Computerized Systems: Implementing the GAMP® 5 Guide This fundamental online course introduces participants to regulatory requirements for computerized …

The ISPE GAMP® Good Practice Guide: Manufacturing Execution Systems - A Strategic and Program Management Approach uses a complete lifecycle approach to the development and use of MES for …