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根据《药品管理法》及《药品管理法实施办法》规定,我国颁布实施了《药品生产质量管理规范》(简称药品GMP)。为了加强对药品生产和质量的监督管理,确保人民用药的安全有效,决定在我国实施药品GMP认证制度。药品GMP认证是国家依法对药品生产企业(车间)和药品品种实施药品GMP监督检查并取得认可的一种制度,是国际药品贸易和药品监督管理的重要内容,也是确保药品质量的稳定性、安全性和有效性的一种科学的、先进的
According to the “Drug Administration Law” and the “Measures for the Implementation of the Drug Administration Law,” China has promulgated and implemented the “Code for the Quality Control of Pharmaceutical Production” (abbreviated as “GMP GMP”). In order to strengthen the supervision and management of pharmaceutical production and quality and ensure the safety and effectiveness of people’s medications, it has been decided to implement the GMP certification system in China. GMP certification of drugs is a system that the State implements drug product GMP supervision and inspection and obtains approval for pharmaceutical production enterprises (workshops) and drug products according to law. It is an important part of international drug trade and drug supervision and management, and also ensures the stability and safety of drug quality. Sexuality and effectiveness of a scientific, advanced