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

The purpose of Good Manufacturing Practices (GMP) is to ensure pharmaceuticals meet the highest quality standards. GMP is a set of rules and regulations for the manufacture, distribution, and storage of pharmaceutical products in the state of Nebraska. The main goal of GMP is to protect public health by ensuring that drug products are of consistent quality and meet the requirements of safety, potency, purity, identity, and strength. GMP is enforced by the Nebraska Department of Health and Human Services, Division of Public Health, and requires companies that manufacture, distribute, and/or store pharmaceuticals to comply with specific safety requirements. Companies must adopt a system of internal controls that complies with these regulations to ensure their products remain free from contamination and the risk of harm. This includes making sure that all personnel involved in the manufacture and handling of pharmaceuticals have received the proper training and that staff, supplies, and equipment are all clean and in good condition. GMP also includes record-keeping requirements, such as maintaining records of all processes and changes concerning quality control, the traceability of ingredients, and the production and storage of the drugs. These records must then be periodically reviewed and updated to ensure that the drug products remain safe and of superior quality. GMP ensures the safety and effectiveness of pharmaceuticals and protects public health and the environment in the state of Nebraska. It is a necessary part of the regulation of pharmaceuticals and is enforced by the Department of Health and Human Services.

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

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