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GAMP-5 (Good Automated Manufacturing Practices) is practical industry guide to achieve compliant computerized systems fit for intended use in an efficient and effective manner. It lays out a set of principles and procedures that help ensure that automation equipment has the required quality. One of the core principles of GAMP is “quality by design”; that quality must be built into each stage of the manufacturing process. As a result, GAMP covers all aspects of production from the raw materials, facility and equipment to the training and hygiene of staff.

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