药品批发企业对药品承运商的第二方审核要点分析

Brief Analysis on Second-Party Audit of Pharmaceutical Carriers by Medicine Wholesale Enterprise

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 medleine wholesale enterprise on its entrusted pharma- ceutical carriers. Methods Based on the requirements of the Good Supply Practice for Pharmaceutical Products and the stamtard technologieal 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 anti with the control,organization structuring,personnel allocation,logistic facilities and equipments,quality control of subcontract transportation,assessment of key control links,onsite operation inspection and logistics information inquiry in the management system documents of the pharmaceutical carriers as the main points of secondparty audit, the medicine wholesale enterprise performs the audit on the entrusted transportation situation to improve itself quality management level and ensure the effeetive control of the quality of entrusted transported pharmaceuticals.