山东省药品批发企业实施新版GSP认证检查中的缺陷项目分析

发布时间：2018-08-26 07:02

【摘要】：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1 494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、1 489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。
[Abstract]:Objective: to provide a reference for Shandong drug wholesale enterprises to adapt to the new edition of Drug quality Management Standard (GSP). Methods: one hundred and sixty drug wholesale enterprises (177s / times) that completed the new edition of GSP certification in Shandong Province from March to December 2015 were taken as the research objects. According to the 15 chapters and articles listed in the guiding principles of GSP On-site Inspection (referred to as "guiding principles"), According to serious defect items (6 items), major defects items (107 items), general defect items (145 items) are divided into three categories, the contents and frequency of three categories of defects items in each chapter are counted. And the content and frequency of a defect project (high frequency defect project) appeared in more than 10% of enterprises, the causes of main defect item and high frequency defect item are analyzed from objective condition and subjective factor, and the preventive measures are put forward. Results & conclusion: a total of 120 defect items were found, and the accumulative frequency was 1 494, including 0 serious defect items, 5 major defects items and 1 489 general defect items, which were mostly concentrated on facilities and equipment. Quality management system documents, storage and maintenance, personnel training four chapters, respectively, up to 225218168159 frequency, high frequency defect project 29, cumulative 999 frequency, are general defect items. Among the 5 main defects and 29 high frequency defect items, there are 5 items of 146-frequency due to objective conditions (such as lack of hardware in the enterprise) and 29 items of 853 frequency due to subjective factors (such as lack of understanding of GSP among enterprise personnel). For the defects caused by objective conditions, it is suggested that the personnel in the posts of the drug wholesale enterprises should find the problems in time and give feedback to the management of the enterprises; for the defects caused by subjective factors, It is suggested that the main persons in charge of the drug wholesale enterprises should improve their quality awareness, attach importance to the quality management professionals and enhance the professional quality of the staff.
【作者单位】：山东省食品药品监督管理局审评认证中心;
【分类号】：R95

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