MHRA现场检查中最常发现的供应商审计缺陷项

[GMP] MHRA现场检查中最常发现的供应商审计缺陷项2015-01-22[url=]洛施德GMP咨询[/url]

                               
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Supplier Qualification is a hot topic in inspections. The inspectorates' summaries of their observations show that things do not always work as desired. In a presentation published by the end of last year by the U.K. authority MHRA (Medicines and Healthcare Products Regulatory Agency), it is stated that "deficiencies relating to 'Quality Systems' are by far the most prevalent observed during inspections". The report "GMP Inspection Deficiencies 2013" covers 630 inspections performed in 2013. According to the report, deficiencies in supplier and contractor audits are amongst the top 5.

供应商审计在现场检查时一直是个热议的主题。检察官的检查结果显示了，很多供应商审计的实施与原先的目标并不相符。在2014年底英国MHRA的一份报告中提到，质量体系审计的相关缺陷是在检查过程中最普遍存在的，而根据这份报告，MHRA在2013年的现场检查中共发现了630个缺陷项，而与供应商审计相关的缺陷比例是高居前五名。

Taking a closer view at the examples of the observations, one can see that problems arise and the whole area of supplier qualification like auditing, audit plan, audit report, adequate contracts and managing unapproved suppliers:

再仔细研究与供应商审计相关的缺陷内容，可以发现审计过程，审计计划，设计报告，合同，和对于未通过审计供应商的管理，是最常发生缺陷的地方，细节如下：

• The respective audit report was not available.
• 没有相关的供应商审计报告
• There was no evidence upon which to base the approved manufacturer decision
• 没有如何判断供应商是否通过审计的依据
• The address of a supplier site differed from the address on the audit report
• 审计报告中明列的供应商地址与供应商实际的地址不同
• In the audit reports it was not apparent what had actually been audited
• 审计报告中并未明列到底审计了哪些内容
• The maintenance and control of the approved supplier list was not robust
• 关于合格供应商的管理措施不够严谨
• API was received although an audit specified that the supplier was no longer approved
• 仍然向未合格供应商继续购买原料药
• Risk based audit planning defines no maximum time frequency
• 基于风险评估的审计计划中没有规定最长的再审计周期
• Quality Assurance Agreement was not kept up to date.
• 供应商提供的质量保证声明并不是最新的版本
• Quality Assurance Agreement failed to adequately describe transportation conditions.
• 供应商提供的质量保证声明未能合适的描述运输的条件
• Approved supplier list was inadequate, e.g. not all suppliers were listed and some suppliers were listed that should not have been.
• 合格供应商的名单是不准确的
• Supplier audit SOP did not cover API suppliers and other services.
• 供应商审计的SOP并未覆盖所有的原料供应商和其他的服务供应商
• 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.
• 在某原料药供应商被判定为不合格后，此供应商已经提供的原料药在仓库内并未被隔离，也未进行拒绝收货的处理。
  
  

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