20150325 ECA新闻：MHRA公布检查前符合性文件

20150325 ECA新闻：MHRA公布检查前符合性文件  

2015-03-26 08:29:09|  分类： ECA新闻

来源：http://zhuyujiao1972.blog.163.com/blog/static/9869472720152268299999/

GMP News
25/03/2015

http://www.gmp-compliance.org/enews_04765_Pre-Inspection-Compliance-Documents-published-by-MHRA.html

Pre-Inspection Compliance Documents published by MHRA

MHRA公布检查前符合性文件

The MHRA has published a revised set of documents which are part of the risk based inspection system of the GMP Inspectorates in the UK. The MHRA has established a system in which companies have to fill out documents about their current compliance status. These documents are intended to help MHRA to get information prior to an inspection (in order to make a risk based decision about the frequency of performing GMP inspections) and in order to get information from the companies if any major changes take place at the manufacturing site. The two documents are called

MHRA公布了一系列修订后的文件，这些文件是英国GMP检查组织基于风险的检查系统的一部分。MHRA已建立了一套系统，在这套系统中，公司必须填写一些关于其当前合规状态的文件。这些文件意在帮助MHRA在检查前获取信息（为了做出基于风险的关于GMP检查频次的决策），也是为了从公司获取信息是否生产场所有重大变更。这2份文件题为：

- Pre-Inspection Compliance Report and

检查前符合性报告
- Interim Compliance Report

期间符合性报告

In the Pre-Inspection Compliance Report the MHRA asks for specific information prior to a GMP Inspection while the Interim Compliance Report should be submitted by sites between inspections following significant changes or in case the inspector requests and Interim Compliance Report from the manufacturing site. The Inspector will use the provided information to decide on the frequency of the inspections. The revision of the Pre-Inspection Report and Interim Compliance Report Guidance published in March 2015 will introduce two new requirements. A section on Data Integrity and a requirement to list molecules handled have been added. Interestingly, the MHRA asks in the above mentioned documents whether the manufacturing site has a policy on data integrity/governance. In addition the MHRA asks for any major changes made to the IT systems and for new IT systems in use. Moreover, the document requires to list all "principal" computerized systems (e.g. ERP, LIMS, MES). The agency asks for the type of IT system, the area in which the IT software is used, the name of the product and supplier, the version of the software and even the last qualification date and any modification, updates and patches performed.

在检查前符合性报告中，MHRA要求公司在检查之前提供特定的信息，而期间符合性报告则要由工厂在发生重大变更时在两次检查之间的时间段提交，或在检查员要求时提交。检查员将利用所提供的信息来决定检查的频次。在2015年3月公布的“检查前报告和期间符合性报告”的修订将引入2个新的要求。一部分是关于数据完整性的，另一个是要求列出所增加的分子清单。有意思的是，MHRA在上述文件中询问生产场所是否有一个关于数据完整性的方针/管理。另外，HMRA询问是否对IT系统有重大变更，是否使用了新的IT系统。还有文件要求列出所有的“基本”计算机化系统（例如，ERP，LIMS，MES）。药监局询问IT系统的类型，IT软件所使用的领域，产品和供应商名称，软件版本，甚至最迟确认日期及所有实施的修订、更新和补丁。

The Interim Compliance Report must be reported by any site which has been inspected by MHRA since 1 April 2009. The reports should be completed by each site holding or named on a UK manufacturing license, sites holding a Blood Establishment Authorisation, API sites, or non UK sites that are named on a UK Product License. The document has to be sent to the inspector who has performed the last inspection of the concerned site. Any failure to submit the Interim Compliance notification of change may lead to a higher risk ranking by MHRA.

所有被MHRA在2009年4月1日后审计过的工厂，必须提交期间符合性报告。该报告应由英国生产许可持有人或冠名人、持有血液场所许可的工厂、原料药工厂，以及非英国本土但在英国药品许可证上被列出名称的工厂完成。文件必须送达对该工厂进行最后一次检查的检查员。未能提交期间符合性变更通知可能会导致MHRA列为更高风险场所。

Source: MHRA Webpage (GMP and GDP Information)

来源：MHRA网站（GMP和GDP信息）

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