“供应商确认”常出现的缺陷

一沙一叶

供应商确认是检查中的一个热门。MHRA曾经公布一份报告，它表明质量系统的缺陷是目前在检查中发现最多的。在这份报告中，共涉及630个缺陷，其中供应商审计的缺陷位列前五。这些缺陷几乎涵盖了供应商审计的所有方面，比如审计、审计计划、审计报告、供应合同、未批准的供应商管理等：

1.       没有为供应商审计制定单独的审计报告；

2.       批准供应商的决定没有充分的依据；

3.       审计报告上的供应商的地址与实际的供应商生产地址不符；

4.       对批准的供应商的维护和控制并不是有效的；

5.       尽管审计明确不再批准该供应商，但是还是接受了其提供的API；

6.       审计计划没有基于风险确定最长的审计频率；

7.       质量保证协议没有及时更新；

8.       质量保证协议没有足够的描述运输的条件。

9.       批准的供应商清单不全面，有些没有在清单上，有些不应该在清单上。

10.   供应商审计SOP没有全面涵盖API供应商和其它服务。

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.
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:

The respective audit report was not available.

There was no evidence upon which to base the approved manufacturer decision

The address of a supplier site differed from the address on the audit report

In the audit reports it was not apparent what had actually been audited

The maintenance and control of the approved supplier list was not robust

API was received although an audit specified that the supplier was no longer approved

Risk based audit planning defines no maximum time frequency

Quality Assurance Agreement was not kept up to date.

Quality Assurance Agreement failed to adequately describe transportation conditions

Approved supplier list was inadequate, e.g. not all suppliers were listed and some suppliers were listed that should not have been.

Supplier audit SOP did not cover API suppliers and other services.

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.

           http://www.gmp-compliance.org/enews_04595_Frequent-Findings-in-Supplier-Qualification.html

东岳红旗飘

学习一下，很条理。

彩虹

收藏了

sd2789390

谢谢翻译与分享，学习中！检查真的很细致，包括协议内容都查，看来任何行为都要有文件支持，而文件中任何决定都要有数据、评估来证明呀！哎！需要进步！

xhf123456

谢谢分享。

syhorchid

学习一下

davidcone

国内企业有时候也很难做，比如你使用有机溶剂，每年5吨。但是石化类企业每年不止这个数量，要大得多，根本不配合你的审计。还有海外供应商的审计也是一个难题。

从目前的趋势来看，企业真的要认真做一个风险管理计划了，确定到底有哪些内容需要进行风险管理，并且及时更新这个计划和回顾。

davidcone 发表于 2015-2-4 10:56
国内企业有时候也很难做，比如你使用有机溶剂，每年5吨。但是石化类企业每年不止这个数量，要大得多，根本不 ...

理想很丰满，现实很骨感。

一沙一叶

davidcone 发表于 2015-2-4 10:56
国内企业有时候也很难做，比如你使用有机溶剂，每年5吨。但是石化类企业每年不止这个数量，要大得多，根本不 ...

是啊，店大欺客啊

yangjin7309

谢谢分享，学习中

1159298971

很给力!很给力!很给力!很给力!