MHRA GMP检查关于供应商管理的缺陷

一沙一叶

供应商资格和外包活动中的单独的协议经常是检查的热门。从检察官们对于发现项的摘要中看来事情并不总是像预期那样。

最近英国当局MHRA在2015年MHRA GMP检查缺陷数据分析中公布了非常有意思和详细的数据，共涵盖了2015年进行的303次GMP检查。

这份报告针对EU-GMP的所有相关的章节和附录都举了例子，这样可以使相关组织可以对照发现的缺陷进行自己的评估，作为自查和持续改进的一部分内容。

当看到为第七章（外包活动）所举的例子的时候，大家可以发现在供应商资格确认的整个领域，例如审计、足够的协议和评价供应商方面都出现问题：

• 没有对协议方适用性进行程序化的评估
• 没有对协议方适用性进行有记录的评估
• 对于很多供应商，技术协议和审计并不存在
• 没有外包活动的技术协议的清单，没有审核周期
• 对于外包服务商能否胜任的评估经常是不完整的
  

EU-GMP第五章指南（生产）也提供了关于审计和供应商确认方面的指南。并且检察官经常并不满意他们看到的：

• API供应商被批准了，但是没有证据证明已经对厂区进行审计
• 对HDPE瓶子供应商进行了审计，但是审计没有回复
• 技术协议没有包含足够的细节
• 批准的供应商清单里面没有包含所有供应商的地址
  

Supplier Qualification and the respective contracts in outsourcing activities are always hot topics in inspections. The inspectorates' summaries of their observations show that things do not always work as desired. Recently, the U.K. authority MHRA (Medicines and Healthcare Products Regulatory Agency) published some very interesting and comprehensive information in their MHRA GMP Inspection Deficiency Data Trend 2015, covering 303 GMP inspections performed in 2015.

The report lists examples for all relevant chapters and annexes of the EU-GMP Guidelines, allowing stakeholders to "perform their own assessment against the deficiency findings as part of self-inspection and continuous improvement".

When it comes to Chapter 7 for example (Outsourced Activities), one can see that problems arise in the whole area of supplier qualification like auditing, adequate contracts and assessing suppliers:

• There was no proceduralised assessment of the suitability of the Contract Acceptor
• There had been no documented assessment of the suitability of Contract Acceptor
• Technical Agreements and audits were not in place for a number of suppliers
• There was no inventory of Technical Agreements for outsourced activities and no review period
• Assessment of the competence of outsourced service providers was not always completed
  

But also Chapter 5 of the EU GMP Guidelines (Production) gives some guidance on auditing and supplier qualification. And the inspectors were not always happy with what they saw:

• API supplier had been approved without any evidence of audit of the facility
• An audit of the HDPE bottle supplier had been performed; however no response to the audit was available.
• The Technical Agreement did not include sufficient details
• The approved vendor list did not include addresses for all suppliers
  

zysx01234

其实GMP条款规定都有，只是企业在对进行供应商管理上投入和重视不足，问题很多是应付性的，依然关注价格便宜就好

静水蓝心

利益驱动

xqliu

现在的供应商审计，一般进行的都不是很到位，浮在表面，没有系统，没有细化，深究起来有很多缺陷。还需不断地完善。

一沙一叶

xqliu 发表于 2017-2-18 17:42
现在的供应商审计，一般进行的都不是很到位，浮在表面，没有系统，没有细化，深究起来有很多缺陷。还需不断 ...

深究起来没有供应商可以用了