论文部分内容阅读
医院自制制剂质量的好坏直接影响治疗效果,药品是特殊商品,其产品质量必须符合《中国药典》或《中国医院制剂规范》的有关规定,按照国家药品监督管理局下发的《医疗机构制剂许可证》验收标准及《医疗机构制剂配制质量管理规范》(试行)的有关规定,对各医疗单位自制制剂的质量管理及检验人员有了更高的要求,对人员机构、房屋设施、仪器设备、检验记录等都有明确规定。从我市对50多家医疗机构制剂许可证验收结果来看,自制制剂的质量管理存在一定问题。本文就制剂检验质量的规范化管理作如下论述。
The quality of homemade preparations directly affects the treatment effect. The medicines are special commodities. The quality of their products must comply with the relevant provisions of the “Chinese Pharmacopoeia” or “Chinese Hospital Preparation Specification”. According to the “Preparation of Medical Institutions” issued by the State Drug Administration, Permit “acceptance criteria and” Medical institutions preparation preparation quality management practices "(for trial implementation) of the relevant provisions of the preparation of the medical units of self-made quality control and inspection staff have higher requirements for personnel agencies, housing facilities, equipment Inspection records and so have a clear provision. From the city of more than 50 medical institutions license inspection results show that the quality of self-made preparations there are some problems. This article examines the quality of the standardized management of the following discussion.