Good Manufacturing Practices (GMP) are regulations set by the United States Food and Drug Administration (FDA) under the authority of the Federal Food, Drug, and Cosmetic Act. These regulations establish minimum quality requirements intended to ensure products are safe, pure, and effective. GMP regulations apply to a wide range of FDA-regulated industries, including pharmaceuticals, medical devices, food, and cosmetics.
GMPs are sometimes referred to as Current Good Manufacturing Practices (cGMP) to emphasize that manufacturers must use up-to-date technologies and systems to meet regulatory expectations. GMP regulations appear throughout Title 21 of the Code of Federal Regulations (CFR), with key parts including:
- Parts 110, 111, and 117 for food and dietary supplements
- Part 210, 211, and 212 for pharmaceuticals and PET drugs
- Parts 225 and 226 for medicated animal feeds
- Part 507 for animal food (including pet food)
- Part 606 for blood and blood component products
- Part 820 for medical devices
For maintenance management purposes, GMP regulations include standards for personnel, buildings and facilities, sanitation controls, equipment maintenance, and production and process controls.
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