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目的了解通过《药品经营质量管理规范》(GSP)认证后药品经营企业的现状。方法以陕西省通过GSP认证的部分药品经营企业为对象,采用个别访谈、实地调研以及问卷调查等方法进行研究。结果与结论现行GSP中的某些条款需要进一步细化和量化;GSP认证应分层次进行。药品经营企业应加强全员培训,提高各类人员的综合素质;充分利用和完善硬件设施,改善经营环境和仓储条件;完善质量管理制度和岗位责任制度,加大考核力度;加强企业药品来源的管理。
Objective To understand the current status of drug management companies after passing the GSP certification. Methods The target of some GSP-certified pharmaceutical companies in Shaanxi Province was investigated using individual interviews, field surveys, and questionnaires. Results and conclusions Certain provisions in the current GSP need to be further refined and quantified; GSP certification should be conducted at different levels. Drug trading companies should strengthen training for all employees and improve the overall quality of various personnel; fully utilize and improve hardware facilities, improve operating environment and storage conditions; improve quality management system and post responsibility system, intensify assessment; strengthen the source of pharmaceuticals for enterprises management.