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

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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.

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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.

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GAMP 4 v GAMP 5

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.

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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

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Product and Process Understanding

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Lifecycle approach within QMS

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Scalable Lifecycle Activities

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Science Based Quality Risk Management

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Leveraging Supplier Involvement