The U.S Food and Drug Administration's (FDA) current good manufacturing practice (cGMP) guidelines help ensure that pharmaceutical drugs and other FDA-regulated products are consistently produced in a controlled environment with quality standards guiding their intended use. The cGMP guidelines are meant to maintain the safety and efficacy of products.
The FDA devised current good manufacturing practice regulations to establish a foundation for drug product quality. The GMP guidelines are minimum requirements. They are flexible enough to allow manufacturers to make decisions based on their organization’s needs regarding the best methods of implementing the necessary controls.
Good manufacturing practice guidelines exist to help ensure that drug products are safe and that they work as they are supposed to. The FDA enforces GMP guidelines to ensure that life sciences companies are using systems that assure proper design, monitoring and control of manufacturing processes and facilities.
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