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医院制剂作为一种市售药品的补充,以其特色而为社会所接受。医院制剂管理是食品药品监管部门的一项重要职责。由于医院制剂室的软、硬件条件与制药企业还有相当的差距,加强医院制剂的质量管理显得尤为重要。本文立足于对上海市62家具备制剂批准文号的医院问卷调研及8家医院的实地走访,对反馈的制剂质量控制包括从源头控制到人员组成到仪器配备等质量管理方面的信息进行整理汇总和分析比较,初步勾勒出医院制剂质量管理的现状,并进一步发现和归纳出存在的突出问题,从医院和政府两个层面提出了相应的管理对策,以进一步提高上海市医院制剂的质量管理水平,保证人民群众用药安全、有效、质量可控。
Hospital preparations as a supplement to commercially available drugs, with its characteristics and social acceptance. Hospital preparation management is an important responsibility of food and drug regulatory authorities. As the hospital preparation room software and hardware conditions and pharmaceutical companies there is still a considerable gap, strengthening the quality control of hospital preparations is particularly important. Based on the questionnaire survey of 62 hospitals in Shanghai with the preparation approval number and the field visits of 8 hospitals, the paper reviews and summarizes the quality control of preparations including the quality control from source control to staffing to equipment equipping And the analysis and comparison, initially outlined the status quo of the quality control of hospital preparations, and further found and summarized the outstanding problems, from the hospital and the government two levels to put forward the corresponding management strategies to further improve the Shanghai hospital preparation quality management level , To ensure that people are safe, effective and quality controllable.