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《药品生产质量管理规范》(Good Manufacturing Practice,GMP)是依照《药品管理法》有关条款制定的,是对药品生产企业实施监督管理和GMP现场检查的依据,是用于规范药品生产企业在药品生产过程中质量管理工作的重要文件,也是药品生产企业为保证药品质量、保证人民用药安全有效、重要且必须执行的文件。
Good Manufacturing Practice (GMP) is formulated in accordance with the relevant provisions of the Drug Administration Law and is the basis for supervision and management and GMP on-site inspection of drug manufacturers. It is also used to regulate the production of pharmaceuticals by pharmaceutical manufacturers Production process of quality management is an important document, but also pharmaceutical manufacturers in order to ensure the quality of medicines to ensure that the drug is safe and effective, important and must be implemented documents.