Inspections – Key Role in Quality of Medicines

Manan Shah, Vishal Shah
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引用次数: 0

Abstract

Global patients depend on medications for their specific purposes. These drugs are manufactured both domestically and internationally. Regardless of where they are manufactured, the Food and Drug Administration (FDA) plays a pivotal role in the United States, regulating drugs, biologics, and devices by not only scrutinizing each marketing holder's application but also guaranteeing that the product's manufacturer complies with current good manufacturing practices (cGMP). This ensures that the product's quality is consistent and is manufactured securely for its intended use.
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检查--药品质量的关键作用
全球患者都依赖药物来达到特定目的。这些药物既有国内生产的,也有国际生产的。无论在哪里生产,美国食品和药物管理局(FDA)在美国药品、生物制剂和器械的监管中都发挥着举足轻重的作用,它不仅要严格审查每个上市持有人的申请,还要保证产品的生产商符合现行的良好生产规范(cGMP)。这就确保了产品的质量始终如一,并能按照预期用途安全生产。
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