澳门医疗器械经营许可证现场核查重点：仓储与质量管理体系搭建

澳门医疗器械经营许可证现场核查重点：仓储与质量管理体系搭建

发表于 2025-04-09 16:30:09 浏览：0

医疗器械经营许可证现场核查是确保企业合规经营的关键环节，仓储管理与质量管理体系是两大核心审查内容。2024年《医疗器械经营监督管理办法》修订后，核查标准进一步细化。本文结合最新法规与实操案例，梳理现场核查要点及体系搭建策略，助力企业高效通过审核。

一、仓储管理现场核查重点

1. 场地合规性

分区管理：
- 必须设置待验区、合格品区、不合格品区、退货区（分区标识清晰，物理隔离）；
- 需配备专用冷链仓储区（冷库、冷藏车、保温箱等），温度实时监控并记录。
面积匹配：
- 仓储面积与经营规模匹配（如经营二类器械需≥50㎡，冷链产品需额外增加冷库面积）；
- 不得与非医疗器械产品混放（如药品与器械需分库或分区分架）。

2. 温湿度控制

设备要求：
- 配备温湿度自动监测设备（精度±0.5℃），数据存储≥3年；
- 冷库需双电路供电或备用发电机组（断电报警装置启动时间≤2分钟）。
监控记录：
- 温湿度数据每30分钟自动记录一次，异常波动需留存调查处理报告；
- 冷链产品需记录运输全程温度（从发货到收货，温度偏差≤2℃）。

3. 库存与效期管理

信息化系统：
- 使用医疗器械GSP管理软件（支持效期预警、近效期产品自动锁定）；
- 库存记录与实物一致（现场抽查误差率≤0.1%）。
近效期产品：
- 设置独立近效期专区，有效期≤6个月的产品需明显标识；
- 不得销售过期产品，销毁记录需留存（视频+纸质签字）。

二、质量管理体系核查重点

1. 制度文件完整性

核心文件清单：
- 《质量管理制度》（含采购、验收、储存、销售、售后服务全流程）；
- 《不合格医疗器械处理程序》《追溯与召回制度》《风险防控预案》。
文件管控要求：
- 制度文件需经法定代表人签批，修订后重新培训并记录；
- 现场随机抽查员工对制度的熟悉程度（回答正确率≥90%）。

2. 人员与培训

关键岗位资质：
- 质量负责人需具备医疗器械相关专业大专以上学历，3年以上从业经验；
- 验收、养护人员需接受省级药监部门培训并持证。
培训记录：
- 年度培训计划及执行记录（含GSP法规、产品知识、操作技能）；
- 培训考核试卷存档（得分≥80分为合格）。

3. 采购与验收流程

供应商管理：
- 供应商档案需包含《医疗器械生产/经营许可证》《产品注册证》；
- 首次采购需签署质量协议（明确质量责任与退换货条款）。
验收标准：
- 到货查验产品标签、说明书、合格证、运输温度记录；
- 冷链产品需在30分钟内完成入库验收（留存开箱视频）。

4. 追溯与风险控制

追溯系统：
- 使用UDI（医疗器械唯一标识）系统，实现“一物一码”追溯；
- 销售记录需包含产品名称、规格、批号、生产企业和购货者信息。
风险处置：
- 建立《不良事件监测与报告制度》，发现风险产品24小时内上报；
- 每季度模拟召回演练，记录响应时间与处置效果。

三、常见问题与整改方案

仓储分区不达标
- 问题：合格区与不合格区仅用标识牌区分，无物理隔离。
- 整改：加装隔断墙或货架隔离，设置独立门禁系统。
温湿度数据造假
- 问题：手工记录代替自动监测，数据不连续。
- 解决：采购合规温湿度监测设备（推荐品牌：德图、欧姆龙）。
质量文件缺失
- 问题：未建立追溯与召回制度，无法提供演练记录。
- 整改：委托第三方机构（如SGS、华测）编制体系文件并辅导实施。
人员资质不符
- 问题：质量负责人学历或经验不达标。
- 解决：招聘持证人员或安排现有人员参加学历提升课程。

四、体系搭建与优化建议

仓储设计策略
- 布局优化：按“出入库动线最短”原则设计货架位置，减少搬运损耗；
- 技术赋能：使用AGV无人搬运车、智能拣货系统提升效率。
质量管理工具
- 信息化系统：选择与药监局数据接口兼容的GSP软件（如用友、金蝶）；
- 风险预警：设置近效期、高投诉产品自动预警阈值。
持续改进机制
- 内审管理：每半年开展一次内部审核，留存《不符合项整改报告》；
- 管理评审：年度评审会由法定代表人主持，评估体系有效性。

结语

医疗器械经营现场核查的核心是“硬件合规、数据可溯、体系健全”。企业需重点关注：

硬件兜底：仓储分区、温湿度设备等必须100%达标；
数据真实：杜绝手工篡改，全程自动化记录；
动态合规：定期更新制度文件，匹配法规变化。

政策依据与工具：

《医疗器械经营质量管理规范》（2024年修订）
国家药监局GSP信息化系统对接标准
UDI数据库查询平台：http://udi.nmpa.gov.cn

（附：现场核查自检表可私信获取，含100项核查要点与评分标准。）

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pageid	1
params	array ( 'catid' => '33', )
parent	array ( 'id' => '5', 'pid' => '0', 'pids' => '0', 'name' => '财务百科', 'dirname' => 'caiwubaike', 'pdirname' => '', 'child' => 1, 'disabled' => '0', 'ismain' => 1, 'childids' => '5,31,32,33,34,35,36', 'thumb' => '', 'show' => '1', 'setting' => array ( 'disabled' => '0', 'linkurl' => '', 'getchild' => '0', 'notedit' => '0', 'seo' => array ( ), 'template' => array ( 'pagesize' => '20', 'mpagesize' => '20', 'page' => '', 'list' => 'list.html', 'category' => 'category.html', 'search' => 'search.html', 'show' => 'show.html', ), 'cat_field' => NULL, 'module_field' => NULL, 'html' => 1, 'urlrule' => 0, ), 'displayorder' => '0', 'tid' => '1', 'content' => '', 'mid' => 'fenzhan', 'pcatpost' => 0, 'topid' => '5', 'catids' => array ( 0 => '5', 1 => '31', 2 => '32', 3 => '33', 4 => '34', 5 => '35', 6 => '36', ), 'is_post' => 0, 'url' => 'http://www.58lecaihui.com/index.php?s=fenzhan&c=category&id=5', 'total' => '请使用count标签查询', 'field' => array ( ), )
related	array ( 31 => array ( 'id' => '31', 'pid' => '5', 'pids' => '0,5', 'name' => '公司注册', 'dirname' => 'gongsizhuce', 'pdirname' => 'caiwubaike/', 'child' => 0, 'disabled' => '0', 'ismain' => 1, 'childids' => 31, 'thumb' => '', 'show' => '1', 'setting' => array ( 'disabled' => '0', 'linkurl' => '', 'getchild' => '0', 'notedit' => '0', 'seo' => array ( ), 'template' => array ( 'pagesize' => '20', 'mpagesize' => '20', 'page' => '', 'list' => 'list.html', 'category' => 'category.html', 'search' => 'search.html', 'show' => 'show.html', ), 'cat_field' => NULL, 'module_field' => NULL, 'html' => 1, 'urlrule' => 0, ), 'displayorder' => '0', 'tid' => '1', 'content' => '', 'mid' => 'fenzhan', 'pcatpost' => 0, 'topid' => '5', 'catids' => array ( 0 => '31', ), 'is_post' => 1, 'url' => 'http://www.58lecaihui.com/index.php?s=fenzhan&c=category&id=31', 'total' => '请使用count标签查询', 'field' => array ( ), ), 32 => array ( 'id' => '32', 'pid' => '5', 'pids' => '0,5', 'name' => '记账报税', 'dirname' => 'jizhangbaoshui', 'pdirname' => 'caiwubaike/', 'child' => 0, 'disabled' => '0', 'ismain' => 1, 'childids' => 32, 'thumb' => '', 'show' => '1', 'setting' => array ( 'disabled' => '0', 'linkurl' => '', 'getchild' => '0', 'notedit' => '0', 'seo' => array ( ), 'template' => array ( 'pagesize' => '20', 'mpagesize' => '20', 'page' => '', 'list' => 'list.html', 'category' => 'category.html', 'search' => 'search.html', 'show' => 'show.html', ), 'cat_field' => NULL, 'module_field' => NULL, 'html' => 1, 'urlrule' => 0, ), 'displayorder' => '0', 'tid' => '1', 'content' => '', 'mid' => 'fenzhan', 'pcatpost' => 0, 'topid' => '5', 'catids' => array ( 0 => '32', ), 'is_post' => 1, 'url' => 'http://www.58lecaihui.com/index.php?s=fenzhan&c=category&id=32', 'total' => '请使用count标签查询', 'field' => array ( ), ), 33 => array ( 'id' => '33', 'pid' => '5', 'pids' => '0,5', 'name' => '财务代理', 'dirname' => 'caiwudaili', 'pdirname' => 'caiwubaike/', 'child' => 0, 'disabled' => '0', 'ismain' => 1, 'childids' => 33, 'thumb' => '', 'show' => '1', 'setting' => array ( 'disabled' => '0', 'linkurl' => '', 'getchild' => '0', 'notedit' => '0', 'seo' => array ( ), 'template' => array ( 'pagesize' => '20', 'mpagesize' => '20', 'page' => '', 'list' => 'list.html', 'category' => 'category.html', 'search' => 'search.html', 'show' => 'show.html', ), 'cat_field' => NULL, 'module_field' => NULL, 'html' => 1, 'urlrule' => 0, ), 'displayorder' => '0', 'tid' => '1', 'content' => '', 'mid' => 'fenzhan', 'pcatpost' => 0, 'topid' => '5', 'catids' => array ( 0 => '33', ), 'is_post' => 1, 'url' => 'http://www.58lecaihui.com/index.php?s=fenzhan&c=category&id=33', 'total' => '请使用count标签查询', 'field' => array ( ), ), 34 => array ( 'id' => '34', 'pid' => '5', 'pids' => '0,5', 'name' => '常见问题', 'dirname' => 'changjianwenti', 'pdirname' => 'caiwubaike/', 'child' => 0, 'disabled' => '0', 'ismain' => 1, 'childids' => 34, 'thumb' => '', 'show' => '1', 'setting' => array ( 'disabled' => '0', 'linkurl' => '', 'getchild' => '0', 'notedit' => '0', 'seo' => array ( ), 'template' => array ( 'pagesize' => '20', 'mpagesize' => '20', 'page' => '', 'list' => 'list.html', 'category' => 'category.html', 'search' => 'search.html', 'show' => 'show.html', ), 'cat_field' => NULL, 'module_field' => NULL, 'html' => 1, 'urlrule' => 0, ), 'displayorder' => '0', 'tid' => '1', 'content' => '', 'mid' => 'fenzhan', 'pcatpost' => 0, 'topid' => '5', 'catids' => array ( 0 => '34', ), 'is_post' => 1, 'url' => 'http://www.58lecaihui.com/index.php?s=fenzhan&c=category&id=34', 'total' => '请使用count标签查询', 'field' => array ( ), ), 35 => array ( 'id' => '35', 'pid' => '5', 'pids' => '0,5', 'name' => '财务政策', 'dirname' => 'caiwuzhengce', 'pdirname' => 'caiwubaike/', 'child' => 0, 'disabled' => '0', 'ismain' => 1, 'childids' => 35, 'thumb' => '', 'show' => '1', 'setting' => array ( 'disabled' => '0', 'linkurl' => '', 'getchild' => '0', 'notedit' => '0', 'seo' => array ( ), 'template' => array ( 'pagesize' => '20', 'mpagesize' => '20', 'page' => '', 'list' => 'list.html', 'category' => 'category.html', 'search' => 'search.html', 'show' => 'show.html', ), 'cat_field' => NULL, 'module_field' => NULL, 'html' => 1, 'urlrule' => 0, ), 'displayorder' => '0', 'tid' => '1', 'content' => '', 'mid' => 'fenzhan', 'pcatpost' => 0, 'topid' => '5', 'catids' => array ( 0 => '35', ), 'is_post' => 1, 'url' => 'http://www.58lecaihui.com/index.php?s=fenzhan&c=category&id=35', 'total' => '请使用count标签查询', 'field' => array ( ), ), 36 => array ( 'id' => '36', 'pid' => '5', 'pids' => '0,5', 'name' => '最新资讯', 'dirname' => 'zuixinzixun', 'pdirname' => 'caiwubaike/', 'child' => 0, 'disabled' => '0', 'ismain' => 1, 'childids' => 36, 'thumb' => '', 'show' => '1', 'setting' => array ( 'disabled' => '0', 'linkurl' => '', 'getchild' => '0', 'notedit' => '0', 'seo' => array ( ), 'template' => array ( 'pagesize' => '20', 'mpagesize' => '20', 'page' => '', 'list' => 'list.html', 'category' => 'category.html', 'search' => 'search.html', 'show' => 'show.html', ), 'cat_field' => NULL, 'module_field' => NULL, 'html' => 1, 'urlrule' => 0, ), 'displayorder' => '0', 'tid' => '1', 'content' => '', 'mid' => 'fenzhan', 'pcatpost' => 0, 'topid' => '5', 'catids' => array ( 0 => '36', ), 'is_post' => 1, 'url' => 'http://www.58lecaihui.com/index.php?s=fenzhan&c=category&id=36', 'total' => '请使用count标签查询', 'field' => array ( ), ), )
urlrule	'/index.php?s=fenzhan&c=show&id=1796&page=[page]'
fix_html_now_url	''
my_web_url	'http://zhuzhou.58lecaihui.com/index.php?c=show&id=1796'
get	array ( 'c' => 'show', 'id' => '1796', 's' => 'fenzhan', )

App.php	FCPATH/CodeIgniter72/Config/App.php
Auto.php	FCPATH/App/Module/Config/Auto.php
Autoload.php	FCPATH/CodeIgniter72/Config/Autoload.php
Cache.php	FCPATH/CodeIgniter72/Config/Cache.php
Cache.php	FCPATH/CodeIgniter72/Extend/Cache.php
Cache.php	FCPATH/Fcms/Library/Cache.php
Category.php	FCPATH/App/Module/Action/Category.php
CodeIgniter.php	FCPATH/CodeIgniter72/Extend/CodeIgniter.php
Constants.php	FCPATH/CodeIgniter72/Config/Constants.php
Content.php	APPPATH/Models/Content.php
Content.php	FCPATH/App/Module/Models/Content.php
Content.php	FCPATH/Fcms/Model/Content.php
ContentSecurityPolicy.php	FCPATH/CodeIgniter72/Config/ContentSecurityPolicy.php
Controller.php	FCPATH/CodeIgniter72/Extend/Controller.php
Database.php	FCPATH/CodeIgniter72/Config/Database.php
Date.php	FCPATH/Fcms/Field/Date.php
Editor.php	FCPATH/Fcms/Field/Editor.php
Exceptions.php	FCPATH/CodeIgniter72/Config/Exceptions.php
Exceptions.php	FCPATH/CodeIgniter72/Extend/Exceptions.php
Field.php	FCPATH/Fcms/Library/Field.php
File.php	FCPATH/Fcms/Field/File.php
Filters.php	FCPATH/CodeIgniter72/Config/Filters.php
Helper.php	FCPATH/Fcms/Core/Helper.php
Hook.php	FCPATH/CodeIgniter72/Extend/Hook.php
Hooks.php	FCPATH/App/Chtml/Config/Hooks.php
Hooks.php	FCPATH/App/Module/Config/Hooks.php
Hooks.php	FCPATH/Fcms/Core/Hooks.php
Init.php	APPPATH/Config/Init.php
Init.php	FCPATH/CodeIgniter72/Init.php
Init.php	FCPATH/Fcms/Init.php
Input.php	FCPATH/Fcms/Library/Input.php
Kint.php	FCPATH/CodeIgniter72/Config/Kint.php
Lang.php	FCPATH/Fcms/Library/Lang.php
Linkages.php	FCPATH/Fcms/Field/Linkages.php
Logger.php	FCPATH/CodeIgniter72/Config/Logger.php
Member.php	FCPATH/Fcms/Model/Member.php
Model.php	FCPATH/CodeIgniter72/Extend/Model.php
Model.php	FCPATH/Fcms/Core/Model.php
Module.php	FCPATH/App/Module/Action/Module.php
Module.php	FCPATH/App/Module/Extends/Home/Module.php
Modules.php	FCPATH/CodeIgniter72/Config/Modules.php
Mwhere.php	APPPATH/Config/Mwhere.php
Paths.php	FCPATH/CodeIgniter72/Config/Paths.php
Phpcmf.php	FCPATH/Fcms/Core/Phpcmf.php
Request.php	FCPATH/CodeIgniter72/Extend/Request.php
Router.php	FCPATH/Fcms/Library/Router.php
Routes.php	APPPATH/Config/Routes.php
Routes.php	FCPATH/CodeIgniter72/Config/Routes.php
Routes.php	FCPATH/CodeIgniter72/Extend/Routes.php
Routes.php	FCPATH/Fcms/Config/Routes.php
Security.php	FCPATH/Fcms/Library/Security.php
Seo.php	FCPATH/Fcms/Library/Seo.php
Service.php	FCPATH/Fcms/Core/Service.php
Services.php	FCPATH/CodeIgniter72/Config/Services.php
Show.php	APPPATH/Controllers/Show.php
Text.php	FCPATH/Fcms/Field/Text.php
Textarea.php	FCPATH/Fcms/Field/Textarea.php
Toolbar.php	FCPATH/CodeIgniter72/Config/Toolbar.php
UserAgents.php	FCPATH/CodeIgniter72/Config/UserAgents.php
Version.php	FCPATH/My/Config/Version.php
View.php	FCPATH/CodeIgniter72/Config/View.php
View.php	FCPATH/CodeIgniter72/Extend/View.php
View.php	FCPATH/Fcms/Core/View.php
custom.php	/www/wwwroot/www.58lecaihui.com/config/custom.php
database.php	/www/wwwroot/www.58lecaihui.com/config/database.php
domain_app.php	/www/wwwroot/www.58lecaihui.com/cache/config/domain_app.php
domain_client.php	/www/wwwroot/www.58lecaihui.com/cache/config/domain_client.php
hooks.php	/www/wwwroot/www.58lecaihui.com/config/hooks.php
index.php	/www/wwwroot/www.58lecaihui.com/fenzhan/pc/index.php
index.php	/www/wwwroot/www.58lecaihui.com/index.php
lang.php	/www/wwwroot/www.58lecaihui.com/api/language/zh-cn/lang.php
site.php	/www/wwwroot/www.58lecaihui.com/cache/config/site.php
system.php	/www/wwwroot/www.58lecaihui.com/cache/config/system.php
template_DS_pc_DS_jizhang_DS_home_DS_fenzhan_DS_fz_footer.html.cache.php	/www/wwwroot/www.58lecaihui.com/cache/template/template_DS_pc_DS_jizhang_DS_home_DS_fenzhan_DS_fz_footer.html.cache.php
template_DS_pc_DS_jizhang_DS_home_DS_fenzhan_DS_fz_header.html.cache.php	/www/wwwroot/www.58lecaihui.com/cache/template/template_DS_pc_DS_jizhang_DS_home_DS_fenzhan_DS_fz_header.html.cache.php
template_DS_pc_DS_jizhang_DS_home_DS_fenzhan_DS_show.html.cache.php	/www/wwwroot/www.58lecaihui.com/cache/template/template_DS_pc_DS_jizhang_DS_home_DS_fenzhan_DS_show.html.cache.php
AutoloadConfig.php	SYSTEMPATH/Config/AutoloadConfig.php
Autoloader.php	SYSTEMPATH/Autoloader/Autoloader.php
BaseBuilder.php	SYSTEMPATH/Database/BaseBuilder.php
BaseCollector.php	SYSTEMPATH/Debug/Toolbar/Collectors/BaseCollector.php
BaseConfig.php	SYSTEMPATH/Config/BaseConfig.php
BaseConnection.php	SYSTEMPATH/Database/BaseConnection.php
BaseHandler.php	SYSTEMPATH/Cache/Handlers/BaseHandler.php
BaseResult.php	SYSTEMPATH/Database/BaseResult.php
BaseService.php	SYSTEMPATH/Config/BaseService.php
Builder.php	SYSTEMPATH/Database/MySQLi/Builder.php
CacheFactory.php	SYSTEMPATH/Cache/CacheFactory.php
CacheInterface.php	SYSTEMPATH/Cache/CacheInterface.php
CliRenderer.php	SYSTEMPATH/ThirdParty/Kint/Renderer/CliRenderer.php
CodeIgniter.php	SYSTEMPATH/CodeIgniter.php
Common.php	SYSTEMPATH/Common.php
Config.php	SYSTEMPATH/Config/Config.php
Config.php	SYSTEMPATH/Database/Config.php
Connection.php	SYSTEMPATH/Database/MySQLi/Connection.php
ConnectionInterface.php	SYSTEMPATH/Database/ConnectionInterface.php
ContentSecurityPolicy.php	SYSTEMPATH/HTTP/ContentSecurityPolicy.php
Controller.php	SYSTEMPATH/Controller.php
Database.php	SYSTEMPATH/Database/Database.php
Database.php	SYSTEMPATH/Debug/Toolbar/Collectors/Database.php
DebugToolbar.php	SYSTEMPATH/Filters/DebugToolbar.php
DotEnv.php	SYSTEMPATH/Config/DotEnv.php
Events.php	SYSTEMPATH/Debug/Toolbar/Collectors/Events.php
Events.php	SYSTEMPATH/Events/Events.php
Exceptions.php	SYSTEMPATH/Debug/Exceptions.php
Factories.php	SYSTEMPATH/Config/Factories.php
Factory.php	SYSTEMPATH/Config/Factory.php
FileHandler.php	SYSTEMPATH/Cache/Handlers/FileHandler.php
FileLocator.php	SYSTEMPATH/Autoloader/FileLocator.php
Files.php	SYSTEMPATH/Debug/Toolbar/Collectors/Files.php
FilterInterface.php	SYSTEMPATH/Filters/FilterInterface.php
Filters.php	SYSTEMPATH/Filters/Filters.php
Header.php	SYSTEMPATH/HTTP/Header.php
IncomingRequest.php	SYSTEMPATH/HTTP/IncomingRequest.php
Kint.php	SYSTEMPATH/ThirdParty/Kint/Kint.php
Logger.php	SYSTEMPATH/Log/Logger.php
LoggerInterface.php	SYSTEMPATH/ThirdParty/PSR/Log/LoggerInterface.php
Logs.php	SYSTEMPATH/Debug/Toolbar/Collectors/Logs.php
Message.php	SYSTEMPATH/HTTP/Message.php
MessageInterface.php	SYSTEMPATH/HTTP/MessageInterface.php
MessageTrait.php	SYSTEMPATH/HTTP/MessageTrait.php
Modules.php	SYSTEMPATH/Modules/Modules.php
Query.php	SYSTEMPATH/Database/Query.php
QueryInterface.php	SYSTEMPATH/Database/QueryInterface.php
Renderer.php	SYSTEMPATH/ThirdParty/Kint/Renderer/Renderer.php
RendererInterface.php	SYSTEMPATH/View/RendererInterface.php
Request.php	SYSTEMPATH/HTTP/Request.php
RequestInterface.php	SYSTEMPATH/HTTP/RequestInterface.php
RequestTrait.php	SYSTEMPATH/HTTP/RequestTrait.php
Response.php	SYSTEMPATH/HTTP/Response.php
ResponseInterface.php	SYSTEMPATH/HTTP/ResponseInterface.php
ResponseTrait.php	SYSTEMPATH/API/ResponseTrait.php
ResponseTrait.php	SYSTEMPATH/HTTP/ResponseTrait.php
Result.php	SYSTEMPATH/Database/MySQLi/Result.php
ResultInterface.php	SYSTEMPATH/Database/ResultInterface.php
RichRenderer.php	SYSTEMPATH/ThirdParty/Kint/Renderer/RichRenderer.php
RouteCollection.php	SYSTEMPATH/Router/RouteCollection.php
RouteCollectionInterface.php	SYSTEMPATH/Router/RouteCollectionInterface.php
Router.php	SYSTEMPATH/Router/Router.php
RouterInterface.php	SYSTEMPATH/Router/RouterInterface.php
Routes.php	SYSTEMPATH/Config/Routes.php
Routes.php	SYSTEMPATH/Debug/Toolbar/Collectors/Routes.php
Services.php	SYSTEMPATH/Config/Services.php
TextRenderer.php	SYSTEMPATH/ThirdParty/Kint/Renderer/TextRenderer.php
Timer.php	SYSTEMPATH/Debug/Timer.php
Timers.php	SYSTEMPATH/Debug/Toolbar/Collectors/Timers.php
Toolbar.php	SYSTEMPATH/Debug/Toolbar.php
URI.php	SYSTEMPATH/HTTP/URI.php
UserAgent.php	SYSTEMPATH/HTTP/UserAgent.php
Utils.php	SYSTEMPATH/ThirdParty/Kint/Utils.php
View.php	SYSTEMPATH/Config/View.php
View.php	SYSTEMPATH/View/View.php
Views.php	SYSTEMPATH/Debug/Toolbar/Collectors/Views.php
init.php	SYSTEMPATH/ThirdParty/Kint/init.php
init_helpers.php	SYSTEMPATH/ThirdParty/Kint/init_helpers.php
url_helper.php	SYSTEMPATH/Helpers/url_helper.php

澳门医疗器械经营许可证现场核查重点：仓储与质量管理体系搭建

一、仓储管理现场核查重点

1. 场地合规性

2. 温湿度控制

3. 库存与效期管理

二、质量管理体系核查重点

1. 制度文件完整性

2. 人员与培训

3. 采购与验收流程

4. 追溯与风险控制

三、常见问题与整改方案

四、体系搭建与优化建议

结语

Database (8 Queries across 0 Connection)

Views

运行时间：0.31ms

模板文件

引用提示

模板变量

Files ( 155 )

Routes

Events

History

View Data

Session User Data

Request ( HTTP/1.1 )

$_GET

Headers

Response ( 200 - OK )

Headers

System Configuration

File:	/www/wwwroot/www.58lecaihui.com/dayrui/App/Fenzhan/Controllers/Show.php
App:	fenzhan
Controller:	show
Method:	index
URI:	fenzhan/show/index
URL:	http://zhuzhou.58lecaihui.com/index.php?c=show&id=1796

Datetime	Status	Method	URL	Content-Type	Is AJAX?
2025-04-18 20:50:03	200	GET	http://handan.58lecaihui.com/	text/html; charset=UTF-8	No
2025-04-18 20:50:02	200	GET	http://zhuzhou.58lecaihui.com/	text/html; charset=UTF-8	No
2025-04-18 20:50:01	200	GET	http://taizhou.58lecaihui.com/	text/html; charset=UTF-8	No
2025-04-18 20:50:00	200	GET	http://panzhihua.58lecaihui.com/	text/html; charset=UTF-8	No
2025-04-18 20:49:59	200	GET	http://lanzhou.58lecaihui.com/	text/html; charset=UTF-8	No
2025-04-18 20:49:58	200	GET	http://yubeiqu.58lecaihui.com/	text/html; charset=UTF-8	No
2025-04-18 20:49:57	200	GET	http://liaoyang.58lecaihui.com/	text/html; charset=UTF-8	No
2025-04-18 20:49:56	200	GET	http://wuyishan.58lecaihui.com/	text/html; charset=UTF-8	No
2025-04-18 20:49:55	200	GET	http://xuchang.58lecaihui.com/	text/html; charset=UTF-8	No
2025-04-18 20:49:54	200	GET	http://xuchang.58lecaihui.com/	text/html; charset=UTF-8	No
2025-04-18 20:49:53	200	GET	http://dongfang.58lecaihui.com/	text/html; charset=UTF-8	No
2025-04-18 20:49:52	200	GET	http://yunfu.58lecaihui.com/	text/html; charset=UTF-8	No
2025-04-18 20:49:51	200	GET	http://shizuishan.58lecaihui.com/	text/html; charset=UTF-8	No
2025-04-18 20:49:50	200	GET	http://shizuishan.58lecaihui.com/	text/html; charset=UTF-8	No
2025-04-18 20:49:49	200	GET	http://shizuishan.58lecaihui.com/	text/html; charset=UTF-8	No
2025-04-18 20:49:48	200	GET	http://renhuai.58lecaihui.com/	text/html; charset=UTF-8	No
2025-04-18 20:49:47	200	GET	http://yunfu.58lecaihui.com/	text/html; charset=UTF-8	No
2025-04-18 20:49:46	200	GET	http://shizuishan.58lecaihui.com/	text/html; charset=UTF-8	No
2025-04-18 20:49:45	200	GET	http://guangzhou.58lecaihui.com/	text/html; charset=UTF-8	No
2025-04-18 20:49:44	200	GET	http://nanchuanqu.58lecaihui.com/	text/html; charset=UTF-8	No

User-Agent	Mozilla/5.0 (compatible; SemrushBot/7~bl; +http://www.semrush.com/bot.html)
Connection	close
Accept-Encoding	gzip,deflate
Accept	text/html, application/rss+xml, application/atom+xml, text/xml, text/rss+xml, application/xhtml+xml
Host	zhuzhou.58lecaihui.com

CodeIgniter Version:	4.0.5
PHP Version:	7.4.33
PHP SAPI:	fpm-fcgi
Environment:	development
Base URL:	http://zhuzhou.58lecaihui.com/
Timezone:	PRC
Locale:	en
Content Security Policy Enabled:	No

Time	Event Name	Times Called
28.89 ms	pre_system	1
0.77 ms	dbquery	8

澳门医疗器械经营许可证现场核查重点：仓储与质量管理体系搭建

​​一、仓储管理现场核查重点​​

​​1. 场地合规性​​

​​2. 温湿度控制​​

​​3. 库存与效期管理​​

​​二、质量管理体系核查重点​​

​​1. 制度文件完整性​​

​​2. 人员与培训​​

​​3. 采购与验收流程​​

​​4. 追溯与风险控制​​

​​三、常见问题与整改方案​​

​​四、体系搭建与优化建议​​

​​结语​​

4.0.5

Database (8 Queries across 0 Connection)

Views

运行时间：0.31ms

模板文件

引用提示

模板变量

Files ( 155 )

Routes

Events

History

View Data

Session User Data

Request ( HTTP/1.1 )

$_GET

Headers

Response ( 200 - OK )

Headers

System Configuration

一、仓储管理现场核查重点

1. 场地合规性

2. 温湿度控制

3. 库存与效期管理

二、质量管理体系核查重点

1. 制度文件完整性

2. 人员与培训

3. 采购与验收流程

4. 追溯与风险控制

三、常见问题与整改方案

四、体系搭建与优化建议

结语