Abbreviation for “Good Manufacturing Practices.” For blood bankers, GMPs are a set of regulations established under the authority of the US Food and Drug Administration used to make sure that we take proactive steps to ensure that our products are safe, pure, and potent (effective) (note that the GMPs apply to pharmaceuticals, medical devices, and food products as well). The GMPs have the force of law, and the FDA takes their enforcement very seriously. These standards include mandates that we address issues such as personnel, training, competency, record-keeping, documentation systems, electronic records, facilities, equipment management (including validation), labeling, and error management. The requirements are fairly general, requiring each facility to implement them in the way that makes the most sense for them (but I should point out that FDA is quick to cite facilities that do not implement in a manner that satisfies an FDA investigator).

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