Manufacturing GMP


GAMP 5 Guidelines

Meet the latest requirements for good automated manufacturing practice (GAMP). Adopt the right quality management system (QMS).

Automate the GAMP 5 process. Reduce audit times and findings, and decrease the risk of product recalls. Improve product quality and safety. Increase customer satisfaction and ensure regulatory compliance. QMS software makes it all possible.

GAMP®5: A Risk-based Approach to Compliant GxP Computerized Systems

Key Concepts of GAMP 5

Free GAMP 5 Resources

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GAMP and Why GAMP 5

In 1991, a group of pharmaceutical experts in the UK started GAMP. They wanted to meet the changing expectations of the FDA for GMP compliance of manufacturing and related systems. Now they are a global organization. GAMP 5 provides “pragmatic guidance, approaches, and tools for the practitioner.” This helps companies find the best approach for validating GxP computerized systems.

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GAMP 4 vs. GAMP 5

GAMP 4 was released in 2001. For seven years, GAMP 4 was used for computerized system validation. Over time, regulatory bodies made significant changes to their approach to regulatory compliance. With those changes, GAMP 5 became necessary. GAMP 5 is designed to be compatible with numerous international standards.

Compliance made easy.

Learn how to meet the requirements of GAMP 5 with the right QMS.

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MasterControl Manufacturing Excellence Reviews

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