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good automated manufacturing practice (GAMP)

Contributor(s): Matthew Haughn

Good automated manufacturing practice (GAMP) is a set of guidelines for manufacturers and other automation users follow to maintain operational efficiency and reliability. GAMP is also a subcommittee of the International Society for Pharmaceutical Engineering (ISPE).

GAMP guidelines are used heavily by the pharmaceutical industry to ensure that drugs are manufactured with the required quality. GAMP COP (Community of Practice) is a pharmaceutical professionals’ forum that ensures continued development and adoption of best practices in the field.

Rather than testing quality control batches, GAMP makes quality testing an integral part of each stage of manufacturing, including facilities, equipment, materials acquisition and staff hygiene. This rigorous employment of standard of operating procedures (SOP) helps ensure purity of manufactured pharmaceuticals.

GAMP publications include practice guides on calibration management, compliance, IT infrastructure, data archiving and process validation. One of the most guidance documents is GAMP 5 Guide: Compliant GxP Computerized Systems, which is often simply referred to as GAMP 5. The document provides an outline for the application of risk management principles and tools for computer system validation.

GAMP was created in 1991 in the United Kingdom to address the pharmaceutical industry’s desire to create guidelines that would improve understanding of changing expectations of regulatory agencies in Europe. This included improved working relationships with agencies in other countries like the United States Food and Drug Administration (FDA). GAMP also sought to encourage understanding of how computer systems validation should be handled in the pharmaceutical industry. Since its creation, the standards organization has become a recognized creator of good practice worldwide.

This was last updated in September 2018

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