GAMP 5 - Good Automated Manufacturing Practice

MasterControl GAMP 5 Offers Good Automated Manufacturing Practice Guidelines for Manufacturing Companies to Comply with Regulated Environments

MasterControl's Quality Management Systems are designed by industry practitioner for automating the GAMP 5 process in any organization. A Quality Management Software system is the crux of any quality and compliance process. It is a regulatory requirement that FDA / global regulatory inspectors and ISO auditors consider critical. An automated GAMP 5 system reduces audit time and findings, and a decreases risk of product recalls. It improves product quality and safety, increases customer satisfaction, and ensures FDA and ISO compliance.

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

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How the White Paper about GAMP 5 can help You

The International Society for Pharmaceutical Engineering (ISPE) issued the worldwide release of GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems in March of 2008. The updated manual for GAMP 5 provides guidelines for good automated manufacturing practices that are referenced in markets around the world, including North and South America, Europe, and Japan.

The white paper that you can download above offers GAMP 5 guidelines and offers ideas on how companies can utilize the processes and templates in the updated manual for GAMP 5 to minimize validation efforts and improve by good automated manufacturing practices.

GAMP Topics in the Whitepaper


History of GAMP

GAMP was started in 1991 by a group of pharmaceutical experts in the UK who wanted to meet the changing FDA expectations for GMP compliance of manufacturing and related systems. Today, it's grown into a global organization.


GAMP 5 Rationale

Since the release of GAMP 4 in 2001 the regulatory bodies had made significant updates in their thinking and approach to regulatory compliance. With these changes, GAMP 5 was necessary.



GAMP 4 has been used for computerized system validation for the last seven years. GAMP 5 is designed to be compatible with IEEE standards, ISO 9000 and 12207, IT Infrastructure Library (ITIL), and other international standards.


Why GAMP 5

GAMP 5 provides "pragmatic guidance, approaches, and tools for the practitioner," guiding companies to help determine the best approach for validating GxP computerized systems.

Five Key Concepts of GAMP 5


Product and Process Understanding


Understanding the product and process is critical in determining system requirements and for making science and risk-based decisions to ensure that the system is “fit for use.”


Lifecycle approach within QMS


Defining a lifecycle approach to a computerized system has been expanded from GAMP 4 to include all phases and activities from concept and implementation through operation and retirement. These activities should be defined within the quality management system (QMS).


Scalable Lifecycle Activities


Within the GAMP 5 guidelines GAMP outlines that lifecycle activities should be scaled according to system impact on patient safety, system complexity, and outcome of supplier assessment.


Science Based Quality Risk Management

Laptop with blue ring binders stacked on

Science Based Quality Risk Management allows companies to focus on critical aspects of the computerized system and develop controls to mitigate those risks. GAMP 5 describes and talks about a five step process for risk management based on ICH Guidelines. They acknowledge that this is not the only approach and that each company needs to decide what approach best works for its intended use.


Leveraging Supplier Involvement


Regulated companies regularly involve suppliers throughout the system life cycle. Suppliers have the knowledge, experience, and documentation to assist companies throughout the system’s life cycle.