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山东省药品零售（连锁）企业许可验收实施标准

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<p> </p> <div style="layout-grid: 28.85pt none"> <div style="line-height: 28pt" align="center"><b><span style="font-size: 14pt">山东省药品零售（连锁）企业许可验收实施标准</span></b></div> <div style="line-height: 28pt" align="center"><b><span style="font-size: 14pt">（</span></b><b><span style="font-size: 14pt">2009</span></b><b><span style="font-size: 14pt">年修订）</span></b></div> <div style="text-indent: 23.25pt; line-height: 20pt"><span style="font-size: 11pt">⒈为了加强药品零售（连锁）企业许可管理，根据《药品管理法》、《药品管理法实施条例》和《药品经营许可证管理办法》的规定,制定本标准。</span></div> <div style="text-indent: 21.6pt; line-height: 20pt"><span style="font-size: 11pt">⒉本标准适用于药品零售（连锁）企业开办和许可事项变更；药品零售（连锁）企业门店的开办和许可事项变更，适用山东省药品零售企业许可验收实施标准（2009年修订）。</span></div> <div style="text-indent: 23.25pt; line-height: 20pt"><span style="font-size: 11pt">⒊药学相关专业是指医学、生物、化学专业。</span></div> <div style="text-indent: 21.6pt; line-height: 20pt"><span style="font-size: 11pt">⒋现场验收时，应逐项进行检查、验收，并逐项做出肯定或否定的评定。根据申请的经营范围允许有合理缺项。现场验收结果全部符合本标准的，评定为验收合格；现场验收结果有不符合本标准，包括项目有缺陷、项目不完整、不齐全的，评定为验收不合格（合理缺项不视为缺陷项）。对验收合格或者验收不合格的，依据《药品经营许可证管理办法》相关规定分别执行。</span></div> <div style="text-indent: 24.1pt; line-height: 20pt"> </div> <span style="font-size: 11pt"><br clear="all" /> </span> <div style="line-height: 20pt"> </div> <table cellspacing="0" cellpadding="0" width="626" border="1" style="border-right: medium none; border-top: medium none; margin: auto auto auto -4.7pt; border-left: medium none; width: 469.4pt; border-bottom: medium none; border-collapse: collapse"> <tbody> <tr style="height: 28.5pt"> <td width="49" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: windowtext 1pt solid; padding-left: 5.4pt; padding-bottom: 0cm; border-left: windowtext 1pt solid; width: 37.1pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; height: 28.5pt; background-color: transparent"><span style="font-size: 11pt"><br clear="all" /> </span> <div align="center"><b><span style="font-size: 10.5pt">序号</span></b></div> </td> <td width="576" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: windowtext 1pt solid; padding-left: 5.4pt; padding-bottom: 0cm; border-left: #ece9d8; width: 432.3pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; height: 28.5pt; background-color: transparent"> <div align="center"><b><span style="font-size: 14pt">检查项目与标准</span></b></div> </td> </tr> <tr style="height: 25.5pt"> <td width="49" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ece9d8; padding-left: 5.4pt; padding-bottom: 0cm; border-left: windowtext 1pt solid; width: 37.1pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; height: 25.5pt; background-color: transparent"> <div align="center"><b> </b></div> </td> <td width="576" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ece9d8; padding-left: 5.4pt; padding-bottom: 0cm; border-left: #ece9d8; width: 432.3pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; height: 25.5pt; background-color: transparent"> <div align="center"><b><span style="font-size: 12pt">第一部分机构与人员</span></b></div> </td> </tr> <tr style="height: 19.85pt"> <td width="49" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ece9d8; padding-left: 5.4pt; padding-bottom: 0cm; border-left: windowtext 1pt solid; width: 37.1pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; height: 19.85pt; background-color: transparent"> <div style="line-height: 16pt" align="center"><span style="font-size: 10pt">1</span></div> </td> <td width="576" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ece9d8; padding-left: 5.4pt; padding-bottom: 0cm; border-left: #ece9d8; width: 432.3pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; height: 19.85pt; background-color: transparent"> <div style="line-height: 15pt"><span style="font-size: 10pt">零售连锁企业应为企业法人，并有2个（含）以上直营连锁门店。</span></div> </td> </tr> <tr style="height: 19.85pt"> <td width="49" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ece9d8; padding-left: 5.4pt; padding-bottom: 0cm; border-left: windowtext 1pt solid; width: 37.1pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; height: 19.85pt; background-color: transparent"> <div style="line-height: 16pt" align="center"><span style="font-size: 10pt">2</span></div> </td> <td width="576" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ece9d8; padding-left: 5.4pt; padding-bottom: 0cm; border-left: #ece9d8; width: 432.3pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; height: 19.85pt; background-color: transparent"> <div style="line-height: 15pt"><span style="font-size: 10pt">企业应设置专门的质量管理机构，机构下设质量管理组、质量验收组。</span></div> </td> </tr> <tr style="height: 19.85pt"> <td width="49" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ece9d8; padding-left: 5.4pt; padding-bottom: 0cm; border-left: windowtext 1pt solid; width: 37.1pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; height: 19.85pt; background-color: transparent"> <div style="line-height: 16pt" align="center"><span style="font-size: 10pt">3</span></div> </td> <td width="576" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ece9d8; padding-left: 5.4pt; padding-bottom: 0cm; border-left: #ece9d8; width: 432.3pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; height: 19.85pt; background-color: transparent"> <div style="line-height: 15pt"><span style="font-size: 10pt">企业质量管理机构应行使质量管理职能，在企业内部对药品质量具有裁决权。</span></div> </td> </tr> <tr style="height: 34.8pt"> <td width="49" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ece9d8; padding-left: 5.4pt; padding-bottom: 0cm; border-left: windowtext 1pt solid; width: 37.1pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; height: 34.8pt; background-color: transparent"> <div align="center"><span style="font-size: 10pt">4</span></div> </td> <td width="576" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ece9d8; padding-left: 5.4pt; padding-bottom: 0cm; border-left: #ece9d8; width: 432.3pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; height: 34.8pt; background-color: transparent"> <div style="line-height: 15pt"><span style="font-size: 10pt">企业法定代表人、企业负责人、企业质量负责人、企业质量管理机构负责人无《药品管理法》第76条、83条规定的情形。</span></div> </td> </tr> <tr style="height: 19.85pt"> <td width="49" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ece9d8; padding-left: 5.4pt; padding-bottom: 0cm; border-left: windowtext 1pt solid; width: 37.1pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; height: 19.85pt; background-color: transparent"> <div style="line-height: 16pt" align="center"><span style="font-size: 10pt">5</span></div> </td> <td nowrap="nowrap" width="576" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ece9d8; padding-left: 5.4pt; padding-bottom: 0cm; border-left: #ece9d8; width: 432.3pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; height: 19.85pt; background-color: transparent"> <div style="line-height: 15pt"><span style="font-size: 10pt">企业负责人应具有大专以上学历，熟悉国家有关药品管理的法律、法规、规章和所经营药品的知识。</span></div> </td> </tr> <tr style="height: 19.85pt"> <td width="49" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ece9d8; padding-left: 5.4pt; padding-bottom: 0cm; border-left: windowtext 1pt solid; width: 37.1pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; height: 19.85pt; background-color: transparent"> <div style="line-height: 16pt" align="center"><span style="font-size: 10pt">6</span></div> </td> <td nowrap="nowrap" width="576" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ece9d8; padding-left: 5.4pt; padding-bottom: 0cm; border-left: #ece9d8; width: 432.3pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; height: 19.85pt; background-color: transparent"> <div style="line-height: 15pt"><span style="font-size: 10pt">企业质量负责人必须是执业药师。</span></div> </td> </tr> <tr style="height: 23.3pt"> <td width="49" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ece9d8; padding-left: 5.4pt; padding-bottom: 0cm; border-left: windowtext 1pt solid; width: 37.1pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; height: 23.3pt; background-color: transparent"> <div style="line-height: 16pt" align="center"><span style="font-size: 10pt">7</span></div> </td> <td width="576" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ece9d8; padding-left: 5.4pt; padding-bottom: 0cm; border-left: #ece9d8; width: 432.3pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; height: 23.3pt; background-color: transparent"> <div style="line-height: 15pt"><span style="font-size: 10pt">企业质量管理机构负责人应是执业药师，并有三年以上（含三年）药品经营质量管理工作经验。</span></div> </td> </tr> <tr style="height: 48.15pt"> <td width="49" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ece9d8; padding-left: 5.4pt; padding-bottom: 0cm; border-left: windowtext 1pt solid; width: 37.1pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; height: 48.15pt; background-color: transparent"> <div align="center"><span style="font-size: 10pt">8</span></div> </td> <td width="576" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ece9d8; padding-left: 5.4pt; padding-bottom: 0cm; border-left: #ece9d8; width: 432.3pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; height: 48.15pt; background-color: transparent"> <div style="line-height: 15pt"><span style="font-size: 10pt">企业从事药品质量管理工作的人员，应具有药师或中药师（含）以上技术职称，或者具有大专（含）以上药学或相关专业的学历，并经相应的专业培训合格，取得岗位合格证书后方可上岗。以上人员应在职在岗，不得为兼职人员。</span></div> </td> </tr> <tr style="height: 32.2pt"> <td width="49" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ece9d8; padding-left: 5.4pt; padding-bottom: 0cm; border-left: windowtext 1pt solid; width: 37.1pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; height: 32.2pt; background-color: transparent"> <div align="center"><span style="font-size: 10pt">9</span></div> </td> <td width="576" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ece9d8; padding-left: 5.4pt; padding-bottom: 0cm; border-left: #ece9d8; width: 432.3pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; height: 32.2pt; background-color: transparent"> <div style="line-height: 15pt"><span style="font-size: 10pt">企业从事药品验收、养护工作的人员，应具有高中或中专（均含）以上文化程度或药师以上职称，并经岗位培训合格，取得岗位合格证书后方可上岗，上述人员营业期间应在岗。</span></div> </td> </tr> <tr style="height: 32.2pt"> <td width="49" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ece9d8; padding-left: 5.4pt; padding-bottom: 0cm; border-left: windowtext 1pt solid; width: 37.1pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; height: 32.2pt; background-color: transparent"> <div align="center"><span style="font-size: 10pt">10</span></div> </td> <td width="576" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ece9d8; padding-left: 5.4pt; padding-bottom: 0cm; border-left: #ece9d8; width: 432.3pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; height: 32.2pt; background-color: transparent"> <div style="line-height: 15pt"><span style="font-size: 10pt">企业应配备1名以上计算机专业大学学历的计算机管理人员，维护企业计算机管理系统，</span><span style="font-size: 10pt">并能处理常见的计算机软、硬件故障。</span></div> </td> </tr> <tr style="height: 31.8pt"> <td width="49" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ece9d8; padding-left: 5.4pt; padding-bottom: 0cm; border-left: windowtext 1pt solid; width: 37.1pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; height: 31.8pt; background-color: transparent"> <div align="center"><span style="font-size: 10pt">11</span></div> </td> <td width="576" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ece9d8; padding-left: 5.4pt; padding-bottom: 0cm; border-left: #ece9d8; width: 432.3pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; height: 31.8pt; background-color: transparent"> <div style="line-height: 15pt"><span style="font-size: 10pt; color: black">企业质量管理、验收、养护、保管、营业等直接接触药品岗位的人员，</span><span style="font-size: 10pt">应在二级以上医疗机构或者疾病预防控制机构进行岗前及年度常规健康检查，并建立完整的健康查体档案。</span><span style="font-size: 10pt">患有精神病、传染病和其他可能污染药品疾病的人员，<span style="color: black">不得从事直接接触药品的工作。</span></span></div> </td> </tr> <tr style="height: 25.5pt"> <td width="49" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ece9d8; padding-left: 5.4pt; padding-bottom: 0cm; border-left: windowtext 1pt solid; width: 37.1pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; height: 25.5pt; background-color: transparent"> <div align="center"> </div> </td> <td width="576" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ece9d8; padding-left: 5.4pt; padding-bottom: 0cm; border-left: #ece9d8; width: 432.3pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; height: 25.5pt; background-color: transparent"> <div style="line-height: 15pt" align="center"><b><span style="font-size: 12pt">第二部分设施与设备</span></b></div> </td> </tr> <tr style="height: 22.7pt"> <td width="49" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ece9d8; padding-left: 5.4pt; padding-bottom: 0cm; border-left: windowtext 1pt solid; width: 37.1pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; height: 22.7pt; background-color: transparent"> <div style="line-height: 15pt" align="center"><span style="font-size: 10pt">12</span></div> </td> <td nowrap="nowrap" width="576" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ece9d8; padding-left: 5.4pt; padding-bottom: 0cm; border-left: #ece9d8; width: 432.3pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; height: 22.7pt; background-color: transparent"> <div style="line-height: 15pt"><span style="font-size: 10pt">企业应有与经营规模相适应的办公、辅助用房。</span></div> </td> </tr> <tr style="height: 51pt"> <td width="49" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ece9d8; padding-left: 5.4pt; padding-bottom: 0cm; border-left: windowtext 1pt solid; width: 37.1pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; height: 51pt; background-color: transparent"> <div style="line-height: 15pt" align="center"><span style="font-size: 10pt">13</span></div> </td> <td width="576" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ece9d8; padding-left: 5.4pt; padding-bottom: 0cm; border-left: #ece9d8; width: 432.3pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; height: 51pt; background-color: transparent"> <div style="line-height: 15pt"><span style="font-size: 10pt">企业应具有符合《药品经营质量管理规范》（以下简称GSP）设置条件的仓库，仓库面积应与其经营品种和规模相适应。企业应配备符合药品特性要求的常温库、阴凉库、冷库（柜）。常温库温度为</span><span style="font-size: 10pt">0</span><span style="font-size: 10pt">～</span><span style="font-size: 10pt">30</span><span style="font-size: 10pt">℃，阴凉库温度为0～</span><span style="font-size: 10pt">20</span><span style="font-size: 10pt">℃</span><span style="font-size: 10pt">，冷库（柜）温度为</span><span style="font-size: 10pt">2</span><span style="font-size: 10pt">～</span><span style="font-size: 10pt">10</span><span style="font-size: 10pt">℃；各库房相对湿度应保持在</span><span style="font-size: 10pt">45</span><span style="font-size: 10pt">～</span><span style="font-size: 10pt">75%</span><span style="font-size: 10pt">之间。</span></div> </td> </tr> <tr style="height: 31.2pt"> <td width="49" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ece9d8; padding-left: 5.4pt; padding-bottom: 0cm; border-left: windowtext 1pt solid; width: 37.1pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; height: 31.2pt; background-color: transparent"> <div style="line-height: 15pt" align="center"><span style="font-size: 10pt">14</span></div> </td> <td width="576" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ece9d8; padding-left: 5.4pt; padding-bottom: 0cm; border-left: #ece9d8; width: 432.3pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; height: 31.2pt; background-color: transparent"> <div style="line-height: 15pt"><span style="font-size: 10pt">企业经营的药品实施委托配送的，应选择一家取得GSP认证证书，并与其经营品种相适应的药品法人批发企业委托配送，并签订包含质量保证等内容的委托配送协议。</span></div> </td> </tr> <tr style="height: 23.25pt"> <td width="49" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ece9d8; padding-left: 5.4pt; padding-bottom: 0cm; border-left: windowtext 1pt solid; width: 37.1pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; height: 23.25pt; background-color: transparent"> <div style="line-height: 15pt" align="center"><span style="font-size: 10pt">15</span></div> </td> <td width="576" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ece9d8; padding-left: 5.4pt; padding-bottom: 0cm; border-left: #ece9d8; width: 432.3pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; height: 23.25pt; background-color: transparent"> <div style="line-height: 15pt"><span style="font-size: 10pt">库区环境整洁、地面平整，无积水和杂草，无粉尘、有害气体等污染源。</span></div> </td> </tr> <tr style="height: 19.85pt"> <td width="49" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ece9d8; padding-left: 5.4pt; padding-bottom: 0cm; border-left: windowtext 1pt solid; width: 37.1pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; height: 19.85pt; background-color: transparent"> <div style="line-height: 15pt" align="center"><span style="font-size: 10pt">16</span></div> </td> <td width="576" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ece9d8; padding-left: 5.4pt; padding-bottom: 0cm; border-left: #ece9d8; width: 432.3pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; height: 19.85pt; background-color: transparent"> <div style="line-height: 15pt"><span style="font-size: 10pt">库区有符合规定要求的消防、安全设施。</span></div> </td> </tr> <tr style="height: 31.2pt"> <td width="49" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ece9d8; padding-left: 5.4pt; padding-bottom: 0cm; border-left: windowtext 1pt solid; width: 37.1pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; height: 31.2pt; background-color: transparent"> <div style="line-height: 15pt" align="center"><span style="font-size: 10pt">17</span></div> </td> <td width="576" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ece9d8; padding-left: 5.4pt; padding-bottom: 0cm; border-left: #ece9d8; width: 432.3pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; height: 31.2pt; background-color: transparent"> <div style="line-height: 15pt"><span style="font-size: 10pt">药品储存作业区、辅助作业区、办公生活区应分开一定距离或有隔离措施，</span><span style="font-size: 10pt">室外装卸、搬运、发运药品时应有防止天气影响的措施。</span></div> </td> </tr> <tr style="height: 19.85pt"> <td width="49" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ece9d8; padding-left: 5.4pt; padding-bottom: 0cm; border-left: windowtext 1pt solid; width: 37.1pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; height: 19.85pt; background-color: transparent"> <div style="line-height: 15pt" align="center"><span style="font-size: 10pt">18</span></div> </td> <td width="576" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ece9d8; padding-left: 5.4pt; padding-bottom: 0cm; border-left: #ece9d8; width: 432.3pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; height: 19.85pt; background-color: transparent"> <div style="line-height: 15pt"><span style="font-size: 10pt">库房内墙壁、顶棚和地面光洁、平整，门窗结构严密。</span></div> </td> </tr> </tbody> </table> </div> <p><span style="font-size: 10pt"><br clear="all" /> </span> <table cellspacing="0" cellpadding="0" width="626" border="1" style="border-right: medium none; border-top: medium none; margin: auto auto auto -4.7pt; border-left: medium none; width: 469.4pt; border-bottom: medium none; border-collapse: collapse"> <tbody> <tr style="height: 47.25pt"> <td width="49" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: windowtext 1pt solid; padding-left: 5.4pt; padding-bottom: 0cm; border-left: windowtext 1pt solid; width: 37.1pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; height: 47.25pt; background-color: transparent"> <div style="line-height: 15pt" align="center"><span style="font-size: 10pt">19</span></div> </td> <td width="576" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: windowtext 1pt solid; padding-left: 5.4pt; padding-bottom: 0cm; border-left: #ece9d8; width: 432.3pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; height: 47.25pt; background-color: transparent"> <div style="line-height: 15pt"><span style="font-size: 10pt">仓库内药品应</span><span style="font-size: 10pt">按质量状态</span><span style="font-size: 10pt">对待验药品、合格药品、发货药品、不合格药品、</span><span style="font-size: 10pt">购进退出药品、销后退回</span><span style="font-size: 10pt">药品</span><span style="font-size: 10pt">实行色标管理：待验药品和购进退出药品、销后退回</span><span style="font-size: 10pt">药品</span><span style="font-size: 10pt">为黄色，合格药品、</span><span style="font-size: 10pt">发货药品</span><span style="font-size: 10pt">为绿色，不合格药品为红色。</span><span style="font-size: 10pt">经营中药饮片者应设置零货称取区。</span></div> </td> </tr> <tr style="height: 24.75pt"> <td width="49" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ece9d8; padding-left: 5.4pt; padding-bottom: 0cm; border-left: windowtext 1pt solid; width: 37.1pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; height: 24.75pt; background-color: transparent"> <div style="line-height: 15pt" align="center"><span style="font-size: 10pt">20</span></div> </td> <td width="576" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ece9d8; padding-left: 5.4pt; padding-bottom: 0cm; border-left: #ece9d8; width: 432.3pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; height: 24.75pt; background-color: transparent"> <div style="line-height: 15pt"><span style="font-size: 10pt">非药品与药品、内服与外用药品应分开存放；中药饮片以及药品中的易燃等危险品种应专库存放。</span></div> </td> </tr> <tr style="height: 19.85pt"> <td width="49" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ece9d8; padding-left: 5.4pt; padding-bottom: 0cm; border-left: windowtext 1pt solid; width: 37.1pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; height: 19.85pt; background-color: transparent"> <div style="line-height: 15pt" align="center"><span style="font-size: 10pt">21</span></div> </td> <td width="576" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ece9d8; padding-left: 5.4pt; padding-bottom: 0cm; border-left: #ece9d8; width: 432.3pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; height: 19.85pt; background-color: transparent"> <div style="line-height: 15pt"><span style="font-size: 10pt">仓库应有避光、通风的设施设备；有符合药品</span><span style="font-size: 10pt">储存作业和</span><span style="font-size: 10pt">安全用电要求的照明设施。</span></div> </td> </tr> <tr style="height: 19.85pt"> <td width="49" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ece9d8; padding-left: 5.4pt; padding-bottom: 0cm; border-left: windowtext 1pt solid; width: 37.1pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; height: 19.85pt; background-color: transparent"> <div style="line-height: 15pt" align="center"><span style="font-size: 10pt">22</span></div> </td> <td width="576" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ece9d8; padding-left: 5.4pt; padding-bottom: 0cm; border-left: #ece9d8; width: 432.3pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; height: 19.85pt; background-color: transparent"> <div style="line-height: 15pt"><span style="font-size: 10pt">仓库应有检测和调节温、湿度的设施。</span></div> </td> </tr> <tr style="height: 19.85pt"> <td width="49" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ece9d8; padding-left: 5.4pt; padding-bottom: 0cm; border-left: windowtext 1pt solid; width: 37.1pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; height: 19.85pt; background-color: transparent"> <div style="line-height: 15pt" align="center"><span style="font-size: 10pt">23</span></div> </td> <td width="576" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ece9d8; padding-left: 5.4pt; padding-bottom: 0cm; border-left: #ece9d8; width: 432.3pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; height: 19.85pt; background-color: transparent"> <div style="line-height: 15pt"><span style="font-size: 10pt">仓库应有防尘、防潮、防霉、防污染以及防虫、防鼠、防鸟等设施。</span></div> </td> </tr> <tr style="height: 19.85pt"> <td width="49" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ece9d8; padding-left: 5.4pt; padding-bottom: 0cm; border-left: windowtext 1pt solid; width: 37.1pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; height: 19.85pt; background-color: transparent"> <div style="line-height: 15pt" align="center"><span style="font-size: 10pt">24</span></div> </td> <td width="576" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ece9d8; padding-left: 5.4pt; padding-bottom: 0cm; border-left: #ece9d8; width: 432.3pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; height: 19.85pt; background-color: transparent"> <div style="line-height: 15pt"><span style="font-size: 10pt">仓库应有适宜拆零及拼箱发货的工作场所和包装物料等的储存场所和设备。</span></div> </td> </tr> <tr style="height: 19.85pt"> <td width="49" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ece9d8; padding-left: 5.4pt; padding-bottom: 0cm; border-left: windowtext 1pt solid; width: 37.1pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; height: 19.85pt; background-color: transparent"> <div style="line-height: 15pt" align="center"><span style="font-size: 10pt">25</span></div> </td> <td width="576" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ece9d8; padding-left: 5.4pt; padding-bottom: 0cm; border-left: #ece9d8; width: 432.3pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; height: 19.85pt; background-color: transparent"> <div style="line-height: 15pt"><span style="font-size: 10pt">经营中药饮片的应设置中药标本（样本）室（柜）。</span></div> </td> </tr> <tr style="height: 19.85pt"> <td width="49" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ece9d8; padding-left: 5.4pt; padding-bottom: 0cm; border-left: windowtext 1pt solid; width: 37.1pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; height: 19.85pt; background-color: transparent"> <div style="line-height: 15pt" align="center"><span style="font-size: 10pt">26</span></div> </td> <td nowrap="nowrap" width="576" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ece9d8; padding-left: 5.4pt; padding-bottom: 0cm; border-left: #ece9d8; width: 432.3pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; height: 19.85pt; background-color: transparent"> <div style="line-height: 15pt"><span style="font-size: 10pt">企业应在库区设置符合要求的验收养护室。验收养护室应有防尘、防潮、温湿度控制设备。</span></div> </td> </tr> <tr style="height: 43.5pt"> <td width="49" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ece9d8; padding-left: 5.4pt; padding-bottom: 0cm; border-left: windowtext 1pt solid; width: 37.1pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; height: 43.5pt; background-color: transparent"> <div style="line-height: 15pt" align="center"><span style="font-size: 10pt">27</span></div> </td> <td width="576" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ece9d8; padding-left: 5.4pt; padding-bottom: 0cm; border-left: #ece9d8; width: 432.3pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; height: 43.5pt; background-color: transparent"> <div style="line-height: 15pt"><span style="font-size: 10pt">企业应建立专用的计算机信息管理系统，并运用该系统对药品的购进、入库验收、在库养护、配送、出库复核进行自动关联控制，能全程覆盖药品购进、储存、门店销售等经营环节质量。制定的制度规定、工作程序、工作记录等应与企业计算机管理系统相融合。</span><span style="font-size: 10pt">具备实现接受药品监督管理部门电子监管的条件。</span></div> </td> </tr> <tr style="height: 19.85pt"> <td width="49" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ece9d8; padding-left: 5.4pt; padding-bottom: 0cm; border-left: windowtext 1pt solid; width: 37.1pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; height: 19.85pt; background-color: transparent"> <div style="line-height: 15pt" align="center"><span style="font-size: 10pt">28</span></div> </td> <td nowrap="nowrap" width="576" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ece9d8; padding-left: 5.4pt; padding-bottom: 0cm; border-left: #ece9d8; width: 432.3pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; height: 19.85pt; background-color: transparent"> <div style="line-height: 15pt"><span style="font-size: 10pt">企业使用的计量器具应符合国家有关规定。</span></div> </td> </tr> <tr style="height: 19.85pt"> <td width="49" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ece9d8; padding-left: 5.4pt; padding-bottom: 0cm; border-left: windowtext 1pt solid; width: 37.1pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; height: 19.85pt; background-color: transparent"> <div style="line-height: 15pt" align="center"><span style="font-size: 10pt">29</span></div> </td> <td nowrap="nowrap" width="576" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ece9d8; padding-left: 5.4pt; padding-bottom: 0cm; border-left: #ece9d8; width: 432.3pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; height: 19.85pt; background-color: transparent"> <div style="line-height: 15pt"><span style="font-size: 10pt">企业或接受委托配送企业应具备符合药品特性要求，与经营规模相适应的运载车辆和设施。</span></div> </td> </tr> <tr style="height: 19.85pt"> <td width="49" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ece9d8; padding-left: 5.4pt; padding-bottom: 0cm; border-left: windowtext 1pt solid; width: 37.1pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; height: 19.85pt; background-color: transparent"> <div style="line-height: 15pt" align="center"><span style="font-size: 10pt">　</span></div> </td> <td nowrap="nowrap" width="576" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ece9d8; padding-left: 5.4pt; padding-bottom: 0cm; border-left: #ece9d8; width: 432.3pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; height: 19.85pt; background-color: transparent"> <div style="line-height: 15pt" align="center"><b><span style="font-size: 12pt">第三部分制度与管理</span></b></div> </td> </tr> <tr style="height: 26.15pt"> <td width="49" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ece9d8; padding-left: 5.4pt; padding-bottom: 0cm; border-left: windowtext 1pt solid; width: 37.1pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; height: 26.15pt; background-color: transparent"> <div style="line-height: 15pt" align="center"><span style="font-size: 10pt">30</span></div> </td> <td nowrap="nowrap" width="576" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ece9d8; padding-left: 5.4pt; padding-bottom: 0cm; border-left: #ece9d8; width: 432.3pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; height: 26.15pt; background-color: transparent"> <div style="line-height: 15pt"><span style="font-size: 10pt">企业及其门店应统一商号、统一采购、统一储存、统一配送、统一管理。门店不得自行采购药品。</span></div> </td> </tr> <tr style="height: 29.6pt"> <td width="49" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ece9d8; padding-left: 5.4pt; padding-bottom: 0cm; border-left: windowtext 1pt solid; width: 37.1pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; height: 29.6pt; background-color: transparent"> <div style="line-height: 15pt" align="center"><span style="font-size: 10pt">31</span></div> </td> <td width="576" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ece9d8; padding-left: 5.4pt; padding-bottom: 0cm; border-left: #ece9d8; width: 432.3pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; height: 29.6pt; background-color: transparent"> <div style="line-height: 15pt"><span style="font-size: 10pt">企业应定期开展药品法律、法规、规章和专业技术、药品知识、职业道德等内容的培训。</span></div> </td> </tr> <tr style="height: 49.05pt"> <td width="49" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ece9d8; padding-left: 5.4pt; padding-bottom: 0cm; border-left: windowtext 1pt solid; width: 37.1pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; height: 49.05pt; background-color: transparent"> <div style="line-height: 15pt" align="center"><span style="font-size: 10pt">32</span></div> </td> <td width="576" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ece9d8; padding-left: 5.4pt; padding-bottom: 0cm; border-left: #ece9d8; width: 432.3pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; height: 49.05pt; background-color: transparent"> <div style="line-height: 15pt"><span style="font-size: 10pt">企业应具有与经营类别、品种相适应，保证药品质量的规章制度及工作程序，并严格执行。内容包括</span><span style="font-size: 10pt">：</span></div> <div style="line-height: 15pt"><span style="font-size: 10pt">（1）质量管理文件的制定与管理；</span></div> <div style="line-height: 15pt"><span style="font-size: 10pt">（</span><span style="font-size: 10pt">2</span><span style="font-size: 10pt">）质量方针和目标管理；</span></div> <div style="line-height: 15pt"><span style="font-size: 10pt">（</span><span style="font-size: 10pt">3</span><span style="font-size: 10pt">）质量体系的审核；</span></div> <div style="line-height: 15pt"><span style="font-size: 10pt">（4）质量管理检查考核制度；</span></div> <div style="line-height: 15pt"><span style="font-size: 10pt">（</span><span style="font-size: 10pt">5</span><span style="font-size: 10pt">）有关部门、组织和人员的质量责任；</span></div> <div style="line-height: 15pt"><span style="font-size: 10pt">（</span><span style="font-size: 10pt">6</span><span style="font-size: 10pt">）质量否决的规定；</span></div> <div style="line-height: 15pt"><span style="font-size: 10pt">（</span><span style="font-size: 10pt">7</span><span style="font-size: 10pt">）质量信息管理；</span></div> <div style="line-height: 15pt"><span style="font-size: 10pt">（</span><span style="font-size: 10pt">8</span><span style="font-size: 10pt">）供货单位资质审核和药品资质审核管理；</span></div> <div style="line-height: 15pt"><span style="font-size: 10pt">（</span><span style="font-size: 10pt">9</span><span style="font-size: 10pt">）药品采购管理；</span></div> <div style="line-height: 15pt"><span style="font-size: 10pt">（</span><span style="font-size: 10pt">10</span><span style="font-size: 10pt">）质量验收管理；</span></div> <div style="line-height: 15pt"><span style="font-size: 10pt">（</span><span style="font-size: 10pt">11</span><span style="font-size: 10pt">）仓储保管、养护和出库复核的管理；</span></div> <div style="line-height: 15pt"><span style="font-size: 10pt">（</span><span style="font-size: 10pt">12</span><span style="font-size: 10pt">）门店销售和售后服务的管理；</span></div> <div style="line-height: 15pt"><span style="font-size: 10pt">（</span><span style="font-size: 10pt">13</span><span style="font-size: 10pt">）有关记录和凭证的管理；</span></div> <div style="line-height: 15pt"><span style="font-size: 10pt">（</span><span style="font-size: 10pt">14</span><span style="font-size: 10pt">）特殊管理药品的管理；</span></div> <div style="line-height: 15pt"><span style="font-size: 10pt">（</span><span style="font-size: 10pt">15</span><span style="font-size: 10pt">）近效期药品、不合格药品和退货药品的管理；</span></div> </td> </tr> <tr style="height: 49.05pt"> <td width="49" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ece9d8; padding-left: 5.4pt; padding-bottom: 0cm; border-left: windowtext 1pt solid; width: 37.1pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; height: 49.05pt; background-color: transparent"> <div style="line-height: 15pt" align="center"> </div> </td> <td width="576" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ece9d8; padding-left: 5.4pt; padding-bottom: 0cm; border-left: #ece9d8; width: 432.3pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; height: 49.05pt; background-color: transparent"> <div style="line-height: 15pt"><span style="font-size: 10pt">（</span><span style="font-size: 10pt">16</span><span style="font-size: 10pt">）质量事故、质量查询和质量投诉的管理；</span></div> <div style="line-height: 15pt"><span style="font-size: 10pt">（</span><span style="font-size: 10pt">17</span><span style="font-size: 10pt">）药品不良反应报告的规定；</span></div> <div style="line-height: 15pt"><span style="font-size: 10pt">（</span><span style="font-size: 10pt">18</span><span style="font-size: 10pt">）卫生和人员健康状况的管理；</span></div> <div style="line-height: 15pt"><span style="font-size: 10pt">（</span><span style="font-size: 10pt">19</span><span style="font-size: 10pt">）计量器具、设施设备管理；</span></div> <div style="line-height: 15pt"><span style="font-size: 10pt">（</span><span style="font-size: 10pt">20</span><span style="font-size: 10pt">）质量方面的教育、培训及考核的规定；</span></div> <div style="line-height: 15pt"><span style="font-size: 10pt">（</span><span style="font-size: 10pt">21</span><span style="font-size: 10pt">）药品配送管理；</span></div> <div style="line-height: 15pt"><span style="font-size: 10pt">（</span><span style="font-size: 10pt">22</span><span style="font-size: 10pt">）门店之间药品调配管理；</span></div> <div style="line-height: 15pt"><span style="font-size: 10pt">（23）计算机系统操作及管理；</span></div> <div style="line-height: 15pt"><span style="font-size: 10pt">（</span><span style="font-size: 10pt">24</span><span style="font-size: 10pt">）药品委托配送管理制度、程序。等。</span></div> </td> </tr> <tr style="height: 192pt"> <td width="49" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ece9d8; padding-left: 5.4pt; padding-bottom: 0cm; border-left: windowtext 1pt solid; width: 37.1pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; height: 192pt; background-color: transparent"> <div style="line-height: 15pt" align="center"><span style="font-size: 10pt">33</span></div> </td> <td width="576" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ece9d8; padding-left: 5.4pt; padding-bottom: 0cm; border-left: #ece9d8; width: 432.3pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; height: 192pt; background-color: transparent"> <div style="line-height: 15pt"><span style="font-size: 10pt">企业应制定门店质量管理制度或工作程序，并严格执行。内容包括：</span></div> <div style="line-height: 15pt"><span style="font-size: 10pt">（1）有关业务和管理岗位的质量责任；</span></div> <div style="line-height: 15pt"><span style="font-size: 10pt">（2）药品验收的管理规定；</span></div> <div style="line-height: 15pt"><span style="font-size: 10pt">（3）药品陈列的管理规定；</span></div> <div style="line-height: 15pt"><span style="font-size: 10pt">（4）药品养护的管理规定；</span></div> <div style="line-height: 15pt"><span style="font-size: 10pt">（5）药品销售凭证及处方管理的规定；</span></div> <div style="line-height: 15pt"><span style="font-size: 10pt">（6）拆零药品的管理规定；</span></div> <div style="line-height: 15pt"><span style="font-size: 10pt">（7）特殊管理药品的保管和销售的规定；</span></div> <div style="line-height: 15pt"><span style="font-size: 10pt">（8）质量事故的处理和报告的规定；</span></div> <div style="line-height: 15pt"><span style="font-size: 10pt">（9）质量信息管理的规定；</span></div> <div style="line-height: 15pt"><span style="font-size: 10pt">（10）药品不良反应报告的规定；</span></div> <div style="line-height: 15pt"><span style="font-size: 10pt">（11）各项卫生管理制度；</span></div> <div style="line-height: 15pt"><span style="font-size: 10pt">（12）人员健康状况的管理规定；</span></div> <div style="line-height: 15pt"><span style="font-size: 10pt">（13）服务质量的管理规定；</span></div> <div style="line-height: 15pt"><span style="font-size: 10pt">（14）中药饮片购、销、存管理规定。等。</span></div> </td> </tr> <tr style="height: 206.25pt"> <td width="49" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ece9d8; padding-left: 5.4pt; padding-bottom: 0cm; border-left: windowtext 1pt solid; width: 37.1pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; height: 206.25pt; background-color: transparent"> <div style="line-height: 15pt" align="center"><span style="font-size: 10pt">34</span></div> </td> <td width="576" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ece9d8; padding-left: 5.4pt; padding-bottom: 0cm; border-left: #ece9d8; width: 432.3pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; height: 206.25pt; background-color: transparent"> <div style="line-height: 15pt"><span style="font-size: 10pt">企业应按规定建立包括下列内容的药品质量管理记录（表式），内容应齐全、真实、完整。</span></div> <div style="line-height: 15pt"><span style="font-size: 10pt">（</span><span style="font-size: 10pt">1</span><span style="font-size: 10pt">）药品购进记录；</span></div> <div style="line-height: 15pt"><span style="font-size: 10pt">（</span><span style="font-size: 10pt">2</span><span style="font-size: 10pt">）购进药品验收记录；</span></div> <div style="line-height: 15pt"><span style="font-size: 10pt">（</span><span style="font-size: 10pt">3</span><span style="font-size: 10pt">）药品储存记录；</span></div> <div style="line-height: 15pt"><span style="font-size: 10pt">（</span><span style="font-size: 10pt">4</span><span style="font-size: 10pt">）库存药品质量养护、检查记录；</span></div> <div style="line-height: 15pt"><span style="font-size: 10pt">（</span><span style="font-size: 10pt">5</span><span style="font-size: 10pt">）药品出库复核、配送记录；</span></div> <div style="line-height: 15pt"><span style="font-size: 10pt">（</span><span style="font-size: 10pt">7</span><span style="font-size: 10pt">）药品质量查询、投诉、抽查情况记录；</span></div> <div style="line-height: 15pt"><span style="font-size: 10pt">（</span><span style="font-size: 10pt">8</span><span style="font-size: 10pt">）不合格药品报废销毁记录；</span></div> <div style="line-height: 15pt"><span style="font-size: 10pt">（9）药品购进退出记录；</span></div> <div style="line-height: 15pt"><span style="font-size: 10pt">（</span><span style="font-size: 10pt">10</span><span style="font-size: 10pt">）药品销后退回验收记录；</span></div> <div style="line-height: 15pt"><span style="font-size: 10pt">（</span><span style="font-size: 10pt">11</span><span style="font-size: 10pt">）库房温湿度记录；</span></div> <div style="line-height: 15pt"><span style="font-size: 10pt">（</span><span style="font-size: 10pt">12</span><span style="font-size: 10pt">）计量器具检定记录；</span></div> <div style="line-height: 15pt"><span style="font-size: 10pt">（</span><span style="font-size: 10pt">13</span><span style="font-size: 10pt">）质量事故报告记录；</span></div> <div style="line-height: 15pt"><span style="font-size: 10pt">（</span><span style="font-size: 10pt">14</span><span style="font-size: 10pt">）质量管理制度执行情况检查和考核记录；</span></div> <div style="line-height: 15pt"><span style="font-size: 10pt">（</span><span style="font-size: 10pt">15</span><span style="font-size: 10pt">）处方留存和处方药销售记录；</span></div> <div style="line-height: 15pt"><span style="font-size: 10pt">（16）药品销售凭证；</span></div> <div style="line-height: 15pt"><span style="font-size: 10pt">（</span><span style="font-size: 10pt">17</span><span style="font-size: 10pt">）药品缺货记录；</span></div> <div style="line-height: 15pt"><span style="font-size: 10pt">（</span><span style="font-size: 10pt">18</span><span style="font-size: 10pt">）顾客意见簿。等。</span></div> </td> </tr> <tr style="height: 225.75pt"> <td width="49" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ece9d8; padding-left: 5.4pt; padding-bottom: 0cm; border-left: windowtext 1pt solid; width: 37.1pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; height: 225.75pt; background-color: transparent"> <div style="line-height: 15pt" align="center"><span style="font-size: 10pt">35</span></div> </td> <td width="576" style="border-right: windowtext 1pt solid; padding-right: 5.4pt; border-top: #ece9d8; padding-left: 5.4pt; padding-bottom: 0cm; border-left: #ece9d8; width: 432.3pt; padding-top: 0cm; border-bottom: windowtext 1pt solid; height: 225.75pt; background-color: transparent"> <div style="line-height: 15pt"><span style="font-size: 10pt">企业应按规定建立包括下列内容的药品质量管理档案（表格），内容应齐全、真实、完整。</span></div> <div style="line-height: 15pt"><span style="font-size: 10pt">（</span><span style="font-size: 10pt">1</span><span style="font-size: 10pt">）员工健康检查档案；</span></div> <div style="line-height: 15pt"><span style="font-size: 10pt">（</span><span style="font-size: 10pt">2</span><span style="font-size: 10pt">）员工培训档案；</span></div> <div style="line-height: 15pt"><span style="font-size: 10pt">（</span><span style="font-size: 10pt">3</span><span style="font-size: 10pt">）药品质量档案；</span></div> <div style="line-height: 15pt"><span style="font-size: 10pt">（</span><span style="font-size: 10pt">4</span><span style="font-size: 10pt">）药品养护档案；</span></div> <div style="line-height: 15pt"><span style="font-size: 10pt">（</span><span style="font-size: 10pt">5</span><span style="font-size: 10pt">）供货方档案；</span></div> <div style="line-height: 15pt"><span style="font-size: 10pt">（</span><span style="font-size: 10pt">6</span><span style="font-size: 10pt">）设施和设备及定期检查、维修、保养档案；</span></div> <div style="line-height: 15pt"><span style="font-size: 10pt">（</span><span style="font-size: 10pt">7</span><span style="font-size: 10pt">）计量器具管理档案；</span></div> <div style="line-height: 15pt"><span style="font-size: 10pt">（</span><span style="font-size: 10pt">8</span><span style="font-size: 10pt">）供货企业资质审批表；</span></div> <div style="line-height: 15pt"><span style="font-size: 10pt">（</span><span style="font-size: 10pt">9</span><span style="font-size: 10pt">）药品资质审批表；</span></div> <div style="line-height: 15pt"><span style="font-size: 10pt">（</span><span style="font-size: 10pt">10</span><span style="font-size: 10pt">）不合格药品报损审批表；</span></div> <div style="line-height: 15pt"><span style="font-size: 10pt">（</span><span style="font-size: 10pt">11</span><span style="font-size: 10pt">）药品质量信息汇总表；</span></div> <div style="line-height: 15pt"><span style="font-size: 10pt">（</span><span style="font-size: 10pt">12</span><span style="font-size: 10pt">）药品质量问题追踪表；</span></div> <div style="line-height: 15pt"><span style="font-size: 10pt">（</span><span style="font-size: 10pt">13</span><span style="font-size: 10pt">）近效期药品催销表；</span></div> <div style="line-height: 15pt"><span style="font-size: 10pt">（</span><span style="font-size: 10pt">14</span><span style="font-size: 10pt">）药品不良反应报告表。等。</span></div> </td> </tr> </tbody> </table> </p>

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