当前位置:首页>考研真题>多家药企被检查:培训无考核试卷、温湿度记录不规范、内审人员评审自己工作……

多家药企被检查:培训无考核试卷、温湿度记录不规范、内审人员评审自己工作……

  • 2026-07-13 21:43:29
多家药企被检查:培训无考核试卷、温湿度记录不规范、内审人员评审自己工作……

编辑 | 三耳
整理 | GSP办公室

630日,某市市场监督管理发布检查情况,部分检查结果如下:

1.****大药房连锁有限公司:1.制定的操作规程未涵盖经营管理与质量控制的各个环节2.未对新进人员进行岗前培训;3.计算机系统无法实现运输环节的药品可追溯;4.培训记录不全5.个别人员健康记录不全。(检查类别:日常检查;处理意见:限期整改

2.****大药房中药饮片库现场检查时不能正常使用(检查类别:回头看检查;处理意见:移交县区责令限期整改

3.****大药房连锁有限公司1.2026年培训计划不全,未包含转岗及新进人员的培训内容 2.更换前的计算机系统未关闭门店请货、仓库发货等功能,更换后的计算机系统不能覆盖经营全过程,无法实现运输环节的药品可追溯。3.各岗位人员计算机系统权限审批不符合制度要求。(检查类别:日常检查;处理意见:限期整改

4.****药房连锁有限公司第二十八分店1.阴凉区域处方药销售存在开架风险;2.工作人员计算机系统登录密码设置过于简单;3.“中药饮片(仅销售药食同源且单味独立预包装的中药饮片)专区标识不正确(检查类别:日常检查;处理意见:限期整改

5.*****大药房连锁有限公司1.抽查****店养护员兼收货员王*,营业员兼收货员贾**岗前培训,培训内容未包含岗位制服及操作规程2. 企业的网络销售制服与实际操作不符3.抽查****北门店,无收货记录的查询权限。(检查类别:日常检查;处理意见:限期整改

6.*******大药房连锁有限公司**1.设施设备档案不全;2.2026年度培训无考核试卷3.个别药品未附说明书计算机系统处方药数据未及时更新。(检查类别:符合性检查;处理意见:限期整改

7.*******大药房连锁有限公司***镇分公司1.缺少药品避光设备、无遮光帘;2.阴凉区域处方药与非处方药未有效隔离;3.部分需阴凉保存法人药品未放置在阴凉区域;4.拆零工具不全5.未凭处方销售处方药。(检查类别:符合性检查;处理意见:责令改正)

8.*******大药房连锁有限公司**社区店1.计算机系统销售处方药时无执业药师审核拦截功能,各岗位人员登陆时采取下拉菜单;2.温湿度记录不规范3.未凭处方销售处方药;4.未建立健康档案;5.培训效果不佳。(检查类别:符合性检查;处理意见:责令改正)

9.*******大药房连锁有限公司凤台东湖新城店1.计算机系统销售处方药时无执业药师审核拦截功能;2.温湿度记录不规范3.阴凉区处方药与非处方药混放;4.未建立健康档案;6.培训效果不佳7.未凭处方销售处方药。(检查类别:符合性检查;处理意见:责令改正)

10.****大药房零售连锁有限公司1.培训效果不佳,如康发分店执业药师对计算机系统查询含麻制剂登记操作不熟悉;2.未按照年度计划开展培训3.总部人员未建立培训档案,未见质量负责人培训记录4.企业制定的药品网络销售管理制度与实际不符 ;5.计算机系统操作人员授权与实际不符;6.企业委托运输无委托运输记录;7.企业委托快递公司运输药品,未对委托运输单位进行审计。(检查类别:日常检查;处理意见:限期整改

11.******大药房连锁有限公司1.2025年年度内审无审批,存在内审人员评审自己工作的情况2.专项内审计划及方案未审批;3.2026培训计划不全,如缺少《**省药品经营和使用质量监督管理办法实施细则》未列入培训计划4 .未对门店网络销售委托配送单位进行审计,签订的质保协议已过期(检查类别:日常检查;处理意见:限期整改

12.****大药房连锁有限公司1.未针对岗位特点开展培训,如开展第三方平台网络销售的开发区分店,岗前培训未包含网络销售制度及操作规程的培训;2 .总部药品网络销售质量安全制度未明确委托配送的相关管理内容;3.抽查开发区分店,调拨药品就收货未验收,即入库上架。抽查凤台二店,销售处方药无执业药师审核拦截;4.企业未对网络销售委托配送企业开展年度审计工作。(检查类别:日常检查;处理意见:限期整改

13.****大学第一附属医院1.北区麻精库未配备温湿度监测设备;2.南区破损药品、需退库药品储存在门诊药房办公室;3.南区药品周转库未配置地架;4.南区静配中心阴凉区未配备温湿度监测设备。(检查类别:专项检查;处理意见:限期整改

14.****医院1. 药库近效期药品管理不规范,个别近效期药品无提示。门诊药房避光保存药品未按照规定储存。2. 清斗记录不准确。3. 住院药房二精药品拆零未建立专门台账。4.药库不合格区、待验区缺少地架,待验区标识不足;门诊中药房、住院药房阴凉设施设备不足。(检查类别:日常检查;处理意见:限期整改

15.**站后社区卫生服务站:1.非药品储存区域存放有药品;2.首营资料收集不全3.未留存冷链运输交接单4.拆零药品未进行拆零记录。(检查类别:飞行检查;处理意见:限期整改)

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  1. CONNECT:[ UseTime:0.000810s ] mysql:host=127.0.0.1;port=3306;dbname=www_sjds;charset=utf8mb4
  2. SHOW FULL COLUMNS FROM `fenlei` [ RunTime:0.000895s ]
  3. SELECT * FROM `fenlei` WHERE `fid` = 0 [ RunTime:0.000325s ]
  4. SELECT * FROM `fenlei` WHERE `fid` = 63 [ RunTime:0.000283s ]
  5. SHOW FULL COLUMNS FROM `set` [ RunTime:0.000497s ]
  6. SELECT * FROM `set` [ RunTime:0.000205s ]
  7. SHOW FULL COLUMNS FROM `article` [ RunTime:0.000590s ]
  8. SELECT * FROM `article` WHERE `id` = 507165 LIMIT 1 [ RunTime:0.000516s ]
  9. UPDATE `article` SET `lasttime` = 1784049639 WHERE `id` = 507165 [ RunTime:0.013750s ]
  10. SELECT * FROM `fenlei` WHERE `id` = 65 LIMIT 1 [ RunTime:0.000284s ]
  11. SELECT * FROM `article` WHERE `id` < 507165 ORDER BY `id` DESC LIMIT 1 [ RunTime:0.000451s ]
  12. SELECT * FROM `article` WHERE `id` > 507165 ORDER BY `id` ASC LIMIT 1 [ RunTime:0.000356s ]
  13. SELECT * FROM `article` WHERE `id` < 507165 ORDER BY `id` DESC LIMIT 10 [ RunTime:0.000699s ]
  14. SELECT * FROM `article` WHERE `id` < 507165 ORDER BY `id` DESC LIMIT 10,10 [ RunTime:0.000682s ]
  15. SELECT * FROM `article` WHERE `id` < 507165 ORDER BY `id` DESC LIMIT 20,10 [ RunTime:0.000564s ]
0.116792s