目的：提高药品批发企业对其委托的药品承运商的监督与管理水平，保证药品质量。方法依据新版《药品经营质量管理规范》和标准技术文件的要求，分析药品批发企业对其委托的药品承运商进行第二方审核的要点。结果与结论药品批发企业以文件审核和现场审核相结合的审核方式，以药品承运商质量管理体系文件的管控、机构设置与人员配备、物流设施设备配置、分包运输的质量控制、关键控制环节的评价、现场作业审核、物流信息查询服务为第二方审核要点，对药品承运商的委托运输情况进行审核，可以提高自身质量管理水平，确保委托运输药品质量的有效控制。%Objective To improve the supervision and management level of the medicine wholesale enterprise on its entrusted pharma-ceutical carriers. Methods Based on the requirements of the Good Supply Practice for Pharmaceutical Products and the standard tech-nological documents,the main points of second-party audit on the entrusted pharmaceutical carriers by the medicine wholesale enter-prise were analyzed. Results and Conclusion By adopting the audit mode of the documents audit combined with on-site audit and with the control,organization structuring,personnel allocation,logistic facilities and equipments,quality control of subcontract transporta-tion,assessment of key control links,on-site operation inspection and logistics information inquiry in the management system documents of the pharmaceutical carriers as the main points of second-party audit,the medicine wholesale enterprise performs the audit on the entrusted transportation situation to improve itself quality management level and ensure the effective control of the quality of entrusted transported pharmaceuticals.
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