MHRA公布了检查前合规文件

一沙一叶

Pre-Inspection Compliance Documents published by MHRA
MHRA公布了检查前合规文件
The MHRA has published a revised set of documents which are partof the risk based inspection system of the GMP Inspectorates in the UK. The MHRAhas established a system in which companies have to fill out documents abouttheir current compliance status. These documents are intended to help MHRA to getinformation prior to an inspection (in order to make a risk based decisionabout the frequency of performing GMP inspections) and in order to getinformation from the companies if any major changes take place at themanufacturing site. The two documents arecalled - Pre-Inspection Compliance Report and - Interim Compliance Report
MHRA公布了一系列修订的文件，这些文件是英国GMP监察部门基于风险的检查系统的一部分内容。这些文件目的是帮助MHRA在检查前获得信息（以基于风险情况来确定实施GMP检查的频率），也能够从公司得到关于生产场地是否发生重大变更的信息。这两个文件叫做：检查前合规报告和中间期合规报告。
In the Pre-Inspection Compliance Report the MHRA asks for specificinformation prior to a GMP Inspection while the Interim Compliance Reportshould be submitted by sites between inspections following significant changesor in case the inspector requests and Interim Compliance Report from themanufacturing site. The Inspector will use the provided information todecide on the frequency of the inspections. The revision of the Pre-Inspection Report andInterim Compliance Report Guidance published in March 2015 will introduce twonew requirements. A section on Data Integrity and a requirement tolist molecules handled have been added. Interestingly, the MHRA asks in the abovementioned documents whether the manufacturing site has a policy on dataintegrity/governance. In addition the MHRA asks for any major changes made to the ITsystems 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, thearea 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 anymodification, updates and patches performed.
在检查前合规报告中，MHRA在GMP检查前索要一些具体的信息而中间期报告是要求生产场地在发生重大变更后或者检查官要求的时候提供。检查官将使用这些提供的信息来确定检查的频率。2015年3月新修订的检查前报告和中间期报告将引入两个新要求。一部分是关于数据完整性的并且要求列出处理的分子。有意思的是，MHRA在上述文件中询问生产场地是否具有关于数据完整性/管理的政策。另外，MHRA还询问IT系统的任何重大变更以及使用的新的IT系统。而且，文件要求列出主要的计算机系统（例如，ERP、LIMS、MES）。他们询问IT系统的类型，IT软件使用的范围，产品和供应商的名字，软件的版本号，甚至最后的确认日期以及任何修改、更新和补丁。
The Interim Compliance Reportmust be reported by any site which has been inspected by MHRA since 1 April2009. The reports should becompleted by each site holding or named on a UK manufacturing license, sitesholding a Blood Establishment Authorisation, API sites, or non UK sites thatare named on a UK Product License. The document has to be sent to the inspector whohas performed the last inspection of the concerned site. Any failure tosubmit the Interim Compliance notification of change may lead to a higher riskranking by MHRA.
自2009年4月1日起被MHRA检查的生产场地必须报告中间期合规报告。持有UK生产许可证或者名字列在上面的生产场地，持有血液产品许可的场地，API场地或者其它非UK场地但名字列在UK产品许可证上的都需要递交报告。这份文件应交给最近对相关场地检查的检查官。如果没有上交变更的中间期合规通知都有可能导致MHRA给予高风险评级。


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