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它有三大目标要素：
It has three major objective elements:
一是将人为的差错控制在非常低的限度。在管理方面要求质量管理部门从生产管理部门独立出来。建立相互监督检查制度。
One is to control human errors to a very low limit. In terms of management, the quality management department is required to be independent from the production management department. Establish a system of mutual supervision and inspection.
二是防止对药品的污染和降低质量。在管理方面，操作室清扫和设备洗净的标准及实施，对生产人员进行严格的卫生教育。操作人员定期进行身体检查，以防止生产人员带有病菌病毒而污染药品。限制非生产人员进入工作间等。在装备方面，防止粉尘对药品的污染，要有相应的机械设备。操作室专用化。对直接接触药品的机械设备、工具、容器，要选用对药物不发生变化的材质制造，防止机械润滑油对药品的污染。
The second is to prevent the pollution of drugs and reduce the quality. In terms of management, the standards and implementation of operation room cleaning and equipment cleaning, and strict health education for production personnel. Operators should have regular physical examination to prevent production personnel from contaminating drugs with germs and viruses. Restrict non production personnel from entering the workshop, etc. In terms of equipment, it is necessary to have corresponding mechanical equipment to prevent the pollution of dust to drugs. The operation room is specialized. The mechanical equipment, tools and containers that directly contact drugs should be made of materials that do not change the drugs to prevent the pollution of mechanical lubricants to drugs.
三是保证高质量产品的质量管理体系。在管理方面，质量管理部门独立行使质量管理职责。有计划的合理的质量控制，在适当条件下保存出厂后的产品质量检查留下的样品。在装备方面，操作室和机械设备要合理配备，采用先进的设备及合理的工艺布局。为保证质量管理的实施，配备必要的实验、检验设备和工具等。
The third is to ensure the quality management system of high-quality products. In terms of management, the quality management department independently performs quality management responsibilities. Have a planned and reasonable quality control, and save the samples left by the product quality inspection after leaving the factory under appropriate conditions. In terms of equipment, the operation room and mechanical equipment should be reasonably equipped, and advanced equipment and reasonable process layout should be adopted. In order to ensure the implementation of quality management, necessary experimental and inspection equipment and tools are equipped.
指导思想：一切药品的质量形式都是生产出来的，而不是单纯检验出来的。
Guiding ideology: all quality forms of drugs are produced, not simply tested.
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