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目前,世界上各发达国家的药品从研制、生产到销售都有相应的质量管理规范,我国也已或将逐步制订与完善这方面的相应法规,以规范我国药品开发、研制、生产与销售行为。下面简要介绍这些管理规范。 药品生产质量管理规范 Good Manufacturing Practice(简称GMP)。该规范规定药品生产企业在药品生产过程中,为确保药品质量而必须遵循的基本准则。GMP内容包括硬件与软件两大部分,硬件是指药品生产企业厂房设备,人员素质要求;软件是指药品的生产管理和质量管理体系和规章制度,我国已于1988年颁布试行了GMP,并于1992年讲
At present, the pharmaceuticals from developed countries all over the world have corresponding quality management standards from research and development to production and marketing. Our country has or will gradually formulate and improve relevant laws and regulations in this regard so as to standardize the development, research, production and sales of pharmaceuticals in China . Below a brief introduction of these management practices. Good Manufacturing Practice (GMP). This code stipulates the basic guidelines that pharmaceutical manufacturers must follow to ensure the quality of their medicines during their manufacture. GMP content includes two parts of hardware and software, hardware refers to the pharmaceutical manufacturing plant equipment, personnel quality requirements; software refers to the pharmaceutical production management and quality management system and rules and regulations, China has promulgated in 1988 piloted GMP, and at Speaking in 1992