【摘要】：目的:為山東省藥品批發(fā)企業(yè)適應(yīng)新版《藥品經(jīng)營質(zhì)量管理規(guī)范》(GSP)的要求提供參考。方法:以2015年3-12月山東省完成新版GSP認證的160家(共177家/次)藥品批發(fā)企業(yè)為研究對象,根據(jù)《GSP現(xiàn)場檢查指導(dǎo)原則》(簡稱《指導(dǎo)原則》)所列15章節(jié)、258項條款,按照嚴重缺陷項目(6項)、主要缺陷項目(107項)、一般缺陷項目(145項)分為3類,統(tǒng)計各章節(jié)中3類缺陷項目出現(xiàn)的內(nèi)容與頻次,以及超過10%的企業(yè)出現(xiàn)的某項缺陷項目(高頻缺陷項目)的內(nèi)容與頻次;從客觀條件和主觀因素兩個方面分析主要缺陷項目和高頻缺陷項目的成因,并提出防范措施。結(jié)果與結(jié)論:共發(fā)現(xiàn)缺陷項目120項,累計1 494頻次,包括嚴重缺陷項目0項、0頻次,主要缺陷項目5項、5頻次,一般缺陷項目115項、1 489頻次,多集中在設(shè)施與設(shè)備、質(zhì)量管理體系文件、儲存與養(yǎng)護、人員培訓(xùn)4個章節(jié),分別達225、218、168、159頻次;高頻缺陷項目29項,累計999頻次,均為一般缺陷項目。在5項主要缺陷和29項高頻缺陷項目中,因客觀條件(如企業(yè)硬件不足)造成的有5項、146頻次;因主觀因素(如企業(yè)人員對GSP的認識不足等)造成的有29項、853頻次。對于因客觀條件造成的缺陷,建議藥品批發(fā)企業(yè)各崗位人員在工作中應(yīng)及時發(fā)現(xiàn)問題,并反饋給企業(yè)管理層;對于因主觀因素造成的缺陷,建議藥品批發(fā)企業(yè)主要負責人應(yīng)提高質(zhì)量意識、重視質(zhì)量管理專業(yè)人才、提升工作人員的專業(yè)素養(yǎng)。
[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.
【作者單位】： 山東省食品藥品監(jiān)督管理局審評認證中心;
【分類號】：R95

【相似文獻】

相關(guān)期刊論文 前5條

1 易方;淺談藥品批發(fā)企業(yè)的質(zhì)量管理和藥品檢驗[J];中國藥事;2000年06期

2 薛團梅;;藥品批發(fā)企業(yè)開展GSP認證準備工作的體會與建議[J];海峽藥學(xué);2009年01期

3 羅京京;陳菡;黃世福;楊士友;;安徽省藥品批發(fā)企業(yè)GSP認證高頻次缺陷項目統(tǒng)計分析[J];安徽醫(yī)藥;2013年04期

4 梁杰康;曾祥衛(wèi);;《廣東省藥品批發(fā)企業(yè)GSP認證現(xiàn)場檢查項目表(試行)》修訂情況簡介[J];今日藥學(xué);2012年07期

5 ;[J];;年期

相關(guān)重要報紙文章 前3條

1 記者 崔鵬;醫(yī)院拖欠藥品批發(fā)企業(yè)貨款問題突出[N];人民日報;2012年

2 記者 宗瑜琮　通訊員 張建波;山東基本藥物配送能力大幅提升[N];中國醫(yī)藥報;2011年

3 耿鴻武;基本藥物配送權(quán)應(yīng)該花落誰家[N];中國醫(yī)藥報;2009年

，

本文編號：2204092