OBJECTIVE:To provide reference for daily controlling management of qualification proof materials for medicine wholesale enterprises,and to avoid risk of out of control.METHODS:According to the requirements of pharmaceutical laws and regulatory documents,the qualification proof materials for medicine wholesale enterprises should be refined during medicine purchase and sale process.The phenomenon of out of control for qualification proof materials was analyzed,management and control measures were put forward.RESULTS & CONCLUSIONS:The information provided by medicine wholesale enterprises for customers include license and information of the enterprise,the qualification certification material of salesman; the information provided by medicine wholesale enterprise for suppliers include license for pharmaceutical trading with the enterprise seal,business licence,etc.The phenomenon of out of control include strict controlling management of enterprise information is absent; there was no controlling measure for pattern of enterprise seal as a record.Medicine wholesale enterprises should conduct standardized management,clear direction for information.They should carry out medicine purchase,authorization management for salesman,necessary definition and counterfeit proof.The sale evidence and seal format provided for customers should be used quantitatively,recorded one by one,controlled effectively and so on.%目的:为药品批发企业资质证明资料的日常控制性管理及规避失控风险提供参考.方法:依据相关药事法规和规范性文件的要求,对药品批发企业在药品购销过程中发放企业资质证明资料的内容进行细化,并对失控现象及原因进行分析,提出管控措施.结果与结论:药品批发企业提供给销售客户的资料应包括本企业证照资料和销售人员个人资质证明资料;作为供货企业的销售客户,药品批发企业提供给供货企业的应包括加盖企业公章的药品经营许可证、营业执照等.失控现象有对本企业的资料未采取严格的控制性管理、企业印章样式备案无管控措施等.药品批发企业应对发放的资料做到规范管理、流向清晰.具体措施有严格做好药品采购、销售人员的授权管理及必要的限定和防伪工作;提供给销售客户留存的销售凭证样张和印章样式,必须限定使用、逐一登记,以有效管控等.
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