What is the purpose of Good Manufacturing Practices (GMP) in the regulation of pharmaceuticals?

Good Manufacturing Practices (GMP) is a set of regulations designed to ensure the safety and quality of pharmaceutical drugs, as outlined in the Florida Public Health Code. In the U.S., GMP is enforced by the U.S. Food and Drug Administration (FDA). The purpose of GMP is to create standards for the initial manufacture, testing, labeling, storage, and distribution of pharmaceuticals. GMP regulations ensure that pharmaceuticals are manufactured, tested, stored, and distributed in accordance with appropriate safety and quality standards. The regulations are designed to ensure that drugs are of the highest quality, are accurately labeled, and provide the intended therapeutic benefit. GMP regulations also ensure that the manufacturing process is monitored and controlled. Production and quality control systems are designed to produce a consistent quality product that meets pre-determined standards. Additionally, GMP regulations require product testing, data management, record keeping, and other quality assurance activities. GMP is essential for ensuring that pharmaceuticals are of the highest quality and safe for use in humans. By meeting the standards set forth by GMP, pharmaceutical manufacturers are able to ensure the safety and efficacy of their products, while also providing assurance to consumers. GMP regulations are enforced by the FDA, and manufacturers that are found to be non-compliant can face penalties, including suspension of production and seizure of products.

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What is the purpose of Good Manufacturing Practices (GMP) in the regulation of pharmaceuticals?

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