关于做好2010年GSP认证跟踪检查的通知
发布作者：市场科 发布时间：
<span id="conten"> <p class="MsoNormal" align="left" style="margin: 0cm 0cm 0pt; text-align: left; mso-layout-grid-align: none"><span lang="EN-US" style="font-size: 20pt; font-family: 华文中宋; mso-bidi-font-family: 华文中宋; mso-font-kerning: 0pt; mso-hansi-font-family: Calibri"><o:p> </o:p></span></p> <p class="MsoNormal" align="center" style="margin: 0cm 0cm 0pt; text-align: center; mso-layout-grid-align: none"><span style="font-size: 16pt; font-family: 仿宋_GB2312; mso-bidi-font-family: 华文中宋; mso-font-kerning: 0pt">济食药监市〔<span lang="EN-US">2010</span>〕<span lang="EN-US">123</span>号<span lang="EN-US"><o:p></o:p></span></span></p> <p class="MsoNormal" align="left" style="margin: 0cm 0cm 0pt; text-align: left; mso-layout-grid-align: none"><span lang="EN-US" style="font-size: 20pt; font-family: 华文中宋; mso-bidi-font-family: 华文中宋; mso-font-kerning: 0pt; mso-hansi-font-family: Calibri"><o:p> </o:p></span></p> <p class="MsoNormal" align="center" style="margin: 0cm 0cm 0pt; text-align: center"><b style="mso-bidi-font-weight: normal"><span style="font-size: 20pt; font-family: 华文中宋; mso-bidi-font-family: 华文中宋; mso-font-kerning: 0pt; mso-hansi-font-family: Calibri">关于做好<span lang="EN-US">2010</span>年<span lang="EN-US">GSP</span>认证跟踪检查的通知<span lang="EN-US"><o:p></o:p></span></span></b></p> <p class="MsoNormal" align="center" style="margin: 0cm 0cm 0pt; text-align: center"><span lang="EN-US" style="font-size: 20pt; font-family: 华文中宋; mso-bidi-font-family: 华文中宋; mso-font-kerning: 0pt; mso-hansi-font-family: Calibri"><o:p> </o:p></span></p> <p class="MsoNormal" align="left" style="margin: 0cm 0cm 0pt; text-align: left"><span style="font-size: 16pt; font-family: 仿宋_GB2312; mso-bidi-font-family: 仿宋_GB2312; mso-font-kerning: 0pt">各县市区食品药品监督管理局：<span lang="EN-US"><o:p></o:p></span></span></p> <p class="MsoNormal" align="left" style="margin: 0cm 0cm 0pt; text-indent: 32pt; text-align: left; mso-char-indent-count: 2.0"><span style="font-size: 16pt; font-family: 仿宋_GB2312; mso-bidi-font-family: 仿宋_GB2312; mso-font-kerning: 0pt">根据国家局《药品经营质量管理规范认证管理办法》和省局《<span lang="EN-US">2010</span>年药品市场监管重点工作安排》要求，近期省局下发了《关于开展<span lang="EN-US">2010</span>年<span lang="EN-US">GSP</span>认证跟踪检查的通知》。为做好这项工作，现就有关问题通知如下：<span lang="EN-US"><o:p></o:p></span></span></p> <p class="MsoNormal" align="left" style="margin: 0cm 0cm 0pt; text-indent: 32pt; text-align: left; mso-char-indent-count: 2.0"><span style="font-size: 16pt; font-family: 黑体; mso-bidi-font-family: 黑体; mso-font-kerning: 0pt">一、跟踪检查的范围<span lang="EN-US"><o:p></o:p></span></span></p> <p class="MsoNormal" align="left" style="margin: 0cm 0cm 0pt; text-indent: 24pt; text-align: left; mso-char-indent-count: 1.5"><span style="font-size: 16pt; font-family: 仿宋_GB2312; mso-bidi-font-family: 仿宋_GB2312; mso-font-kerning: 0pt">（一）截止<span lang="EN-US">2010</span>年<span lang="EN-US">6</span>月<span lang="EN-US">GSP</span>认证期满<span lang="EN-US">24</span>个月的企业。<span lang="EN-US"><o:p></o:p></span></span></p> <p class="MsoNormal" align="left" style="margin: 0cm 0cm 0pt; text-indent: 24pt; text-align: left; mso-char-indent-count: 1.5"><span style="font-size: 16pt; font-family: 仿宋_GB2312; mso-bidi-font-family: 仿宋_GB2312; mso-font-kerning: 0pt">（二）新开办企业<span lang="EN-US">GSP</span>认证期满<span lang="EN-US">12</span>个月的企业。<span lang="EN-US"><o:p></o:p></span></span></p> <p class="MsoNormal" align="left" style="margin: 0cm 0cm 0pt; text-indent: 24pt; text-align: left; mso-char-indent-count: 1.5"><span style="font-size: 16pt; font-family: 仿宋_GB2312; mso-bidi-font-family: 仿宋_GB2312; mso-font-kerning: 0pt">（三）<span lang="EN-US">2009</span>年以来有下列情形之一的企业：<span lang="EN-US"><o:p></o:p></span></span></p> <p class="MsoNormal" align="left" style="margin: 0cm 0cm 0pt; text-indent: 32pt; text-align: left; mso-char-indent-count: 2.0"><span lang="EN-US" style="font-size: 16pt; font-family: 仿宋_GB2312; mso-bidi-font-family: 仿宋_GB2312; mso-font-kerning: 0pt">1</span><span style="font-size: 16pt; font-family: 仿宋_GB2312; mso-bidi-font-family: 仿宋_GB2312; mso-font-kerning: 0pt">．药品监督抽验出现不合格药品的企业；<span lang="EN-US"><o:p></o:p></span></span></p> <p class="MsoNormal" align="left" style="margin: 0cm 0cm 0pt; text-indent: 32pt; text-align: left; mso-char-indent-count: 2.0"><span lang="EN-US" style="font-size: 16pt; font-family: 仿宋_GB2312; mso-bidi-font-family: 仿宋_GB2312; mso-font-kerning: 0pt">2</span><span style="font-size: 16pt; font-family: 仿宋_GB2312; mso-bidi-font-family: 仿宋_GB2312; mso-font-kerning: 0pt">．有群众举报的企业；<span lang="EN-US"><o:p></o:p></span></span></p> <p class="MsoNormal" align="left" style="margin: 0cm 0cm 0pt; text-indent: 32pt; text-align: left; mso-char-indent-count: 2.0"><span lang="EN-US" style="font-size: 16pt; font-family: 仿宋_GB2312; mso-bidi-font-family: 仿宋_GB2312; mso-font-kerning: 0pt">3.</span><span style="font-size: 16pt; font-family: 仿宋_GB2312; mso-bidi-font-family: 仿宋_GB2312; mso-font-kerning: 0pt">上年度<span lang="EN-US">GSP</span>跟踪检查不合格的企业；<span lang="EN-US"><o:p></o:p></span></span></p> <p class="MsoNormal" align="left" style="margin: 0cm 0cm 0pt; text-indent: 32pt; text-align: left; mso-char-indent-count: 2.0"><span lang="EN-US" style="font-size: 16pt; font-family: 仿宋_GB2312; mso-bidi-font-family: 仿宋_GB2312; mso-font-kerning: 0pt">4.</span><span style="font-size: 16pt; font-family: 仿宋_GB2312; mso-bidi-font-family: 仿宋_GB2312; mso-font-kerning: 0pt">违反有关药品法律、法规，受到行政处罚的企业。<span lang="EN-US"><o:p></o:p></span></span></p> <p class="MsoNormal" align="left" style="margin: 0cm 0cm 0pt; text-indent: 16pt; text-align: left; mso-char-indent-count: 1.0"><span style="font-size: 16pt; font-family: 仿宋_GB2312; mso-bidi-font-family: 仿宋_GB2312; mso-font-kerning: 0pt">（四）<span lang="EN-US">GSP</span>认证证书<span lang="EN-US">6</span>个月内到有效期需重新认证的、<span lang="EN-US">2009</span>年以来已实施<span lang="EN-US">GSP</span>认证专项检查的、疫苗经营企业暂不安排跟踪检查。<span lang="EN-US"><o:p></o:p></span></span></p> <p class="MsoNormal" align="left" style="margin: 0cm 0cm 0pt; text-indent: 32pt; text-align: left; mso-char-indent-count: 2.0"><span style="font-size: 16pt; font-family: 黑体; mso-bidi-font-family: 黑体; mso-font-kerning: 0pt">二、检查的依据<span lang="EN-US"><o:p></o:p></span></span></p> <p class="MsoNormal" align="left" style="margin: 0cm 0cm 0pt; text-indent: 32pt; text-align: left; mso-char-indent-count: 2.0"><span lang="EN-US" style="font-size: 16pt; font-family: 仿宋_GB2312; mso-bidi-font-family: 仿宋_GB2312; mso-font-kerning: 0pt">GSP</span><span style="font-size: 16pt; font-family: 仿宋_GB2312; mso-bidi-font-family: 仿宋_GB2312; mso-font-kerning: 0pt">认证跟踪检查要依据《药品经营质量管理规范》及其实施细则、《<span lang="EN-US">GSP</span>认证检查评定标准》、《药品经营许可证理办法》、《药品经营质量管理规范认证管理办法》及《山东省药品经营企业<span lang="EN-US">GSP</span>认证跟踪检查管理办法（试行）》等有关规定。<span lang="EN-US"><o:p></o:p></span></span></p> <p class="MsoNormal" align="left" style="margin: 0cm 0cm 0pt; text-indent: 32pt; text-align: left; mso-char-indent-count: 2.0"><span style="font-size: 16pt; font-family: 黑体; mso-bidi-font-family: 黑体; mso-font-kerning: 0pt">三、检查的重点<span lang="EN-US"><o:p></o:p></span></span></p> <p class="MsoNormal" align="left" style="margin: 0cm 0cm 0pt; text-indent: 24pt; text-align: left; mso-char-indent-count: 1.5"><span style="font-size: 16pt; font-family: 仿宋_GB2312; mso-bidi-font-family: 仿宋_GB2312; mso-font-kerning: 0pt">今年<span lang="EN-US">GSP</span>跟踪检查，要结合药品安全专项整治行动一并进行。检查内容主要包含以下方面：<span lang="EN-US"><o:p></o:p></span></span></p> <p class="MsoNormal" align="left" style="margin: 0cm 0cm 0pt; text-indent: 16pt; text-align: left; mso-char-indent-count: 1.0"><span style="font-size: 16pt; font-family: 仿宋_GB2312; mso-bidi-font-family: 仿宋_GB2312; mso-font-kerning: 0pt">（一）药品经营法律法规执行情况；<span lang="EN-US"><o:p></o:p></span></span></p> <p class="MsoNormal" align="left" style="margin: 0cm 0cm 0pt; text-indent: 16pt; text-align: left; mso-char-indent-count: 1.0"><span style="font-size: 16pt; font-family: 仿宋_GB2312; mso-bidi-font-family: 仿宋_GB2312; mso-font-kerning: 0pt">（二）企业质量管理制度执行情况；<span lang="EN-US"><o:p></o:p></span></span></p> <p class="MsoNormal" align="left" style="margin: 0cm 0cm 0pt; text-indent: 16pt; text-align: left; mso-char-indent-count: 1.0"><span style="font-size: 16pt; font-family: 仿宋_GB2312; mso-bidi-font-family: 仿宋_GB2312; mso-font-kerning: 0pt">（三）质量管理人员和药学技术人员在职在岗情况；<span lang="EN-US"><o:p></o:p></span></span></p> <p class="MsoNormal" align="left" style="margin: 0cm 0cm 0pt; text-indent: 16pt; text-align: left; mso-char-indent-count: 1.0"><span style="font-size: 16pt; font-family: 仿宋_GB2312; mso-bidi-font-family: 仿宋_GB2312; mso-font-kerning: 0pt">（四）企业依法经营蛋白同化制剂、肽类激素、易制毒化学药品情况；<span lang="EN-US"><o:p></o:p></span></span></p> <p class="MsoNormal" align="left" style="margin: 0cm 0cm 0pt; text-indent: 16pt; text-align: left; mso-char-indent-count: 1.0"><span style="font-size: 16pt; font-family: 仿宋_GB2312; mso-bidi-font-family: 仿宋_GB2312; mso-font-kerning: 0pt">（五）药品购进、验收、储存、销售及票证管理情况；<span lang="EN-US"><o:p></o:p></span></span></p> <p class="MsoNormal" align="left" style="margin: 0cm 0cm 0pt; text-indent: 16pt; text-align: left; mso-char-indent-count: 1.0"><span style="font-size: 16pt; font-family: 仿宋_GB2312; mso-bidi-font-family: 仿宋_GB2312; mso-font-kerning: 0pt">（六）温湿度调节设施设备运转情况；<span lang="EN-US"><o:p></o:p></span></span></p> <p class="MsoNormal" align="left" style="margin: 0cm 0cm 0pt; text-indent: 16pt; text-align: left; mso-char-indent-count: 1.0"><span style="font-size: 16pt; font-family: 仿宋_GB2312; mso-bidi-font-family: 仿宋_GB2312; mso-font-kerning: 0pt">（七）企业整治体外循环、挂靠经营、走票等违法违规行为情况；<span lang="EN-US"><o:p></o:p></span></span></p> <p class="MsoNormal" align="left" style="margin: 0cm 0cm 0pt; text-indent: 16pt; text-align: left; mso-char-indent-count: 1.0"><span style="font-size: 16pt; font-family: 仿宋_GB2312; mso-bidi-font-family: 仿宋_GB2312; mso-font-kerning: 0pt">（八）认证检查及监督检查中发现问题整改落实情况。<span lang="EN-US"><o:p></o:p></span></span></p> <p class="MsoNormal" align="left" style="margin: 0cm 0cm 0pt; text-align: left"><span style="font-size: 16pt; font-family: 仿宋_GB2312; mso-bidi-font-family: 仿宋_GB2312; mso-font-kerning: 0pt">对于检查中发现的违法违规问题要依据《药品管理法》等法律法规予以查处，直至取消药品经营资格。<span lang="EN-US"><o:p></o:p></span></span></p> <p class="MsoNormal" align="left" style="margin: 0cm 0cm 0pt; text-indent: 32pt; text-align: left; mso-char-indent-count: 2.0"><span style="font-size: 16pt; font-family: 黑体; mso-bidi-font-family: 黑体; mso-font-kerning: 0pt">四、工作要求<span lang="EN-US"><o:p></o:p></span></span></p> <p class="MsoNormal" align="left" style="margin: 0cm 0cm 0pt; text-indent: 16pt; text-align: left; mso-char-indent-count: 1.0"><span style="font-size: 16pt; font-family: 仿宋_GB2312; mso-bidi-font-family: 仿宋_GB2312; mso-font-kerning: 0pt">（一）<span lang="EN-US">GSP</span>认证跟踪检查是落实《药品经营质量管理规范认证管理办法》要求、做好<span lang="EN-US">2010</span>年药品市场监管的一项重要工作，是督促企业认真执行<span lang="EN-US">GSP</span>各项规定、落实企业质量安全第一责任人责任、确保药品质量的有效手段。药品经营企业要自觉开展<span lang="EN-US">GSP</span>认证内审和自查，各县市区食品药品监督管理部门要结合实际，适时安排辖区内药品经营企业的<span lang="EN-US">GSP</span>认证跟踪检查。<span lang="EN-US"><o:p></o:p></span></span></p> <p class="MsoNormal" align="left" style="margin: 0cm 0cm 0pt; text-indent: 24pt; text-align: left; mso-char-indent-count: 1.5"><span style="font-size: 16pt; font-family: 仿宋_GB2312; mso-bidi-font-family: 仿宋_GB2312; mso-font-kerning: 0pt">（二）<span lang="EN-US">GSP</span>认证跟踪检查实行分级负责。药品批发企业的跟踪检查由省局负责；零售连锁企业由市局会同县市区局实施；药品零售企业由县市区局负责，市局进行抽查。省局、市局将于<span lang="EN-US">7</span>－<span lang="EN-US">9</span>月间分别对药品批发企业、药品零售连锁企业进行跟踪检查。各县市区局要结合本地实际，制订跟踪检查方案，切实做好辖区内药品零售企业的跟踪检查，并将检查情况于<span lang="EN-US">9</span>月底前报市局药品市场监管科。对监督检查不符合《<span lang="EN-US">GSP</span>认证检查评定标准》的企业要依法处理。<span lang="EN-US"><o:p></o:p></span></span></p> <p class="MsoNormal" align="left" style="margin: 0cm 0cm 0pt; text-indent: 24pt; text-align: left; mso-char-indent-count: 1.5"><span style="font-size: 16pt; font-family: 仿宋_GB2312; mso-bidi-font-family: 仿宋_GB2312; mso-font-kerning: 0pt">（三）严格执行检查纪律和认证检查标准，确保跟踪检查质量。跟踪检查过程中要认真遵守<span lang="EN-US">GSP</span>认证现场检查纪律，确保监督检查工作的公平、公正。<span lang="EN-US"><o:p></o:p></span></span></p> <p class="MsoNormal" align="right" style="margin: 0cm 0cm 0pt; text-align: right"><span lang="EN-US" style="font-size: 16pt; font-family: 仿宋_GB2312; mso-bidi-font-family: 仿宋_GB2312; mso-font-kerning: 0pt"><o:p> </o:p></span></p> <p class="MsoNormal" align="right" style="margin: 0cm 0cm 0pt; text-align: right"><span lang="EN-US" style="font-size: 16pt; font-family: 仿宋_GB2312; mso-bidi-font-family: 仿宋_GB2312; mso-font-kerning: 0pt"><o:p> </o:p></span></p> <p class="MsoNormal" align="right" style="margin: 0cm 0cm 0pt; text-align: right"><span lang="EN-US" style="font-size: 16pt; font-family: 仿宋_GB2312; mso-bidi-font-family: 仿宋_GB2312; mso-font-kerning: 0pt"><o:p> </o:p></span></p> <p class="MsoNormal" align="right" style="margin: 0cm 0cm 0pt; text-align: right"><span lang="EN-US" style="font-size: 16pt; font-family: 仿宋_GB2312; mso-bidi-font-family: 仿宋_GB2312; mso-font-kerning: 0pt"><o:p> </o:p></span></p> <p class="MsoNormal" align="right" style="margin: 0cm 0cm 0pt; text-align: right"><span lang="EN-US" style="font-size: 16pt; font-family: 仿宋_GB2312; mso-bidi-font-family: 仿宋_GB2312; mso-font-kerning: 0pt"><o:p> </o:p></span></p> <p class="MsoNormal" align="right" style="margin: 0cm 32pt 0pt 0cm; text-align: right"><st1:chsdate w:st="on" isrocdate="False" islunardate="False" day="10" month="8" year="2010"><span style="font-size: 16pt; font-family: 仿宋_GB2312; mso-bidi-font-family: 仿宋_GB2312; mso-font-kerning: 0pt">二</span><span style="font-size: 16pt; font-family: 宋体; mso-bidi-font-family: 宋体; mso-font-kerning: 0pt; mso-hansi-font-family: Calibri">〇</span><span style="font-size: 16pt; font-family: 仿宋_GB2312; mso-bidi-font-family: 仿宋_GB2312; mso-font-kerning: 0pt">一</span><span style="font-size: 16pt; font-family: 宋体; mso-bidi-font-family: 宋体; mso-font-kerning: 0pt; mso-hansi-font-family: Calibri">〇</span><span style="font-size: 16pt; font-family: 仿宋_GB2312; mso-bidi-font-family: 仿宋_GB2312; mso-font-kerning: 0pt">年八月十日</span></st1:chsdate><span lang="EN-US" style="font-size: 16pt; font-family: 仿宋_GB2312; mso-bidi-font-family: 仿宋_GB2312; mso-font-kerning: 0pt"><o:p></o:p></span></p> <p class="MsoNormal" align="right" style="margin: 0cm 32pt 0pt 0cm; text-align: right"><span lang="EN-US" style="font-size: 16pt; font-family: 仿宋_GB2312; mso-bidi-font-family: 仿宋_GB2312; mso-font-kerning: 0pt"><o:p> </o:p></span></p> <p class="MsoNormal" align="right" style="margin: 0cm 32pt 0pt 0cm; text-align: right"><span lang="EN-US" style="font-size: 16pt; font-family: 仿宋_GB2312; mso-bidi-font-family: 仿宋_GB2312; mso-font-kerning: 0pt"><o:p> </o:p></span></p> <p class="MsoNormal" align="right" style="margin: 0cm 32pt 0pt 0cm; text-align: right"><span lang="EN-US" style="font-size: 16pt; font-family: 仿宋_GB2312; mso-bidi-font-family: 仿宋_GB2312; mso-font-kerning: 0pt"><o:p> </o:p></span></p> <p class="MsoNormal" align="right" style="margin: 0cm 32pt 0pt 0cm; text-align: right"><span lang="EN-US" style="font-size: 16pt; font-family: 仿宋_GB2312; mso-bidi-font-family: 仿宋_GB2312; mso-font-kerning: 0pt"><o:p> </o:p></span></p> <p class="MsoNormal" align="right" style="margin: 0cm 32pt 0pt 0cm; 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