Good Manufacturing Practice (GMP) is the set of principles and practices that ensure products are consistently produced and controlled to the quality standards appropriate to their intended use. It originated in pharmaceutical regulation, where the consequences of a contaminated or incorrectly dosed batch are severe and cannot be detected by inspecting the finished product alone.
The central idea is that quality has to be built into the process rather than tested into the product. Sampling a finished batch tells you about the samples; only a controlled, validated and documented process gives confidence about everything you did not test.
Device manufacturing is governed by quality system requirements rather than pharmaceutical GMP as such. Internationally this means ISO 13485, and in the United States the FDA's requirements for devices historically sat in the Quality System Regulation, which the agency has been harmonising with ISO 13485 through its Quality Management System Regulation. The practical expectations, validated processes, traceability and documented control, are common to both worlds.
Regulators increasingly frame GMP findings in terms of data integrity, often summarised by the ALCOA principles: records should be attributable, legible, contemporaneous, original and accurate. This applies as much to electronic batch records and laboratory systems as to paper, which is why software used in manufacturing and quality processes must itself be validated for its intended use.
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