GMP审计过程中常见问题汇总ppt（英国药监局）

GMP审计过程中常见问题汇总ppt（英国药监局）2015-02-02[url=]GMP行业新闻[/url]

相对于其他药监局，英国药监局MHRA会不定期地将一些发现的质量问题做成ppt放官网公布，比如本次。

这个ppt是整个GMP检查的变更、分类、详细说明汇总。

在2013年MHRAS公布的630项GMP审计问题中，关于供应商及委托服务的问题，位于前5位。

详细信息如：

• The respective audit report was not available. 无审计报告
• There was no evidence upon which to base the approved manufacturer decision 无数据支持审批决定
• The address of a supplier site differed from the address on the audit report 供应商实际位置同报告位置不同
• In the audit reports it was not apparent what had actually been audited 具体审计内容不清
• The maintenance and control of the approved supplier list was not robust 合格供应商清单不确定
• API was received although an audit specified that the supplier was no longer approved 仍从未批准供应商处购买API
• Risk based audit planning defines no maximum time frequency 以风险管理为基础的审计未定义审计周期
• Quality Assurance Agreement was not kept up to date. QAA未及时更新
• Quality Assurance Agreement failed to adequately describe transportation conditions. QAA未描述运输要求
• Approved supplier list was inadequate, e.g. not all suppliers were listed and some suppliers were listed that should not have been. 供应商清单不充分，有些未列，有些多列
• Supplier audit SOP did not cover API suppliers and other services. 审计SOP未包括API及服务供应商
• After concluding that an API supplier was not suitable for the supply, the API already received and held on stock was not quarantined and rejected. 审计不合格的供应商，其API产品未受控制
  
  

http://webarchive.nationalarchives.gov.uk/20141205150130/http://www.mhra.gov.uk/home/groups/pl-a/documents/websiteresources/con464241.pdf

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