目的：为山东省药品批发企业适应新版《药品经营质量管理规范》（GSP）的要求提供参考。方法：以2015年3－12月山东省完成新版GSP认证的160家（共177家/次）药品批发企业为研究对象，根据《GSP现场检查指导原则》（简称《指导原则》）所列15章节、258项条款，按照严重缺陷项目（6项）、主要缺陷项目（107项）、一般缺陷项目（145项）分为3类，统计各章节中3类缺陷项目出现的内容与频次，以及超过10％的企业出现的某项缺陷项目（高频缺陷项目）的内容与频次；从客观条件和主观因素两个方面分析主要缺陷项目和高频缺陷项目的成因，并提出防范措施。结果与结论：共发现缺陷项目120项，累计1494频次，包括严重缺陷项目0项、0频次，主要缺陷项目5项、5频次，一般缺陷项目115项、1489频次，多集中在设施与设备、质量管理体系文件、储存与养护、人员培训4个章节，分别达225、218、168、159频次；高频缺陷项目29项，累计999频次，均为一般缺陷项目。在5项主要缺陷和29项高频缺陷项目中，因客观条件（如企业硬件不足）造成的有5项、146频次；因主观因素（如企业人员对GSP的认识不足等）造成的有29项、853频次。对于因客观条件造成的缺陷，建议药品批发企业各岗位人员在工作中应及时发现问题，并反馈给企业管理层；对于因主观因素造成的缺陷，建议药品批发企业主要负责人应提高质量意识、重视质量管理专业人才、提升工作人员的专业素养。%OBJECTIVE:To provide reference in the adaptation of the new-version Good Supply Practice(GSP)in pharmaceu-tical wholesale enterprises in Shandong province. METHODS:The research sample was got by 160(total 177 times)pharmaceuti-cal wholesale enterprises which completed for the GSP certification in Shandong Province from Mar. to Dec. in 2015. According to the 15 chapters,258 items were classified serious items (6 items),important items (107 items),general items (145 items) in GSP Site Inspection Guidelines(hereinafter referred to as Guidelines),a summary was conducted for the contents and the frequen-cies of the items in each chapter,and one defective item(high-frequency item)in more than 10% enterprises;the reasons of im-portant defective items and high-frequency items were analyzed in aspects of objective conditions and subjective factors,then pre-ventative measures were presented. RESULTS & CONCLUSIONS:Totally 120 defective items were found,involving 1 494 times, including 0 serious item(0 times),5 important items(5 times),115 general items(1 489 times),mostly concentrated in facility and equipment (225 times),quality management system document (218 times),storage and conversation (168 times) and staff training(159 times),and 29 high-frequency items(999 times),which were general items. In the 5 important and 29 high-frequen-cy items,there were 5(146 times)caused by objective conditions(such as lack of hardware);and 29(853 times)caused by sub-jective factors. To solve the defective items caused by objective conditions(such as staff insufficient understanding for GSP),it is suggested that staff in pharmaceutical wholesale enterprises should find the problems,and give their feedback to management in time;to solve the defective items caused by subjective factors,it is suggested that enterprises’leaders should increase their quality awareness,emphasize talents of quality management,and upgrade employees’attainment.
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