Who inspects the Inspectors?
谁检查检查官？
As part of the Joint Audit Programme (JAP) for EEA GMP Inspectorates, EU inspectorates are audited by other competent authorities. It is run under the Heads of Medicines Agencies (HMA) and on behalf of HMA by the GMDP IWG. JAP aims at achieving and maintaining equivalence between Member States' national inspectorates responsible for GMP. It was established in October 2000 and is an important part of the quality system adopted by all GMP inspectorates in the EU. 作为EEA GMP检查组织联合审计计划（JAP）的一部分，EU检查组织是要接受其它有资质的机构的审计的。这个计划是由药物监管机构首脑（HMA）运行，由GMDP专家工作组代表HMA执行的。JAP的目标是达到并维持不同成员国负责GMP检查的国家检查组织之间的等同性。它于2000年10月建立，是EU内所有GMP检查组织所采纳的质量体系的一个重要部分。
JAP auditors are senior GMP inspectors, further qualified for auditing inspectorates through specific training. A list of qualified JAP auditors is maintained by the Compliance Group, which is a subgroup of the GMDP IWG. JAP auditors also provide technical advice and support to accession countries before they become EU Member States. Mutual Recognition Agreement and other international partners are invited on a case-by-case basis to join JAP audits of EU Member States inspectorates as observers.
JAP审计员都是资深的GMP检查员，经过特定的培训具备审计检查员的资质。法规符合工作组维护着一份有资质的JAP审计员清单，它是GMDP专家工作组的一个小组。JAP审计员在相关国家成为EU成员国之前也会为他们提供技术建议和支持。根据情况在各案基础上，会邀请互认协议和其它国家伙伴加入JAP对EU成员国审计中作为观察员。
Now the U.K. Medicines and Healthcare products Regulatory Agency has published a [url=]MHRA Inspectorate Blog "Who Inspects the Inspectors?"[/url] and gives some insight in such an audit. The information dates back to October 2015 when the MHRA was audited under the JAP. The audit was also observed by the U.S. FDA. Their focus was on the JAP process itself rather than the MHRA's systems. This FDA participation was part of the Mutual Reliance Initiative looking to establish equivalence between Europe and US GMPs. The audit also included two on-site MHRA GMP inspections being observed.
现在英国药监发布了一份MHRA检查博客“谁检查检查员？”并且给出了此类审计中的一些内幕。信息所署日期为2015年10月，那是MHRA接受JAP审计的时间。审计中有美国FDA作为观察员。他们主要关注JAP的流程本身，而不是MHRA的系统。这次FDA的参与是互认信赖倡议的一部分，寻求在欧洲和美国GMP之间建立等价性。审计还包括对2次MHRA的GMP现场检查的观察。
Interesting is the statement that the 6 month preparation period and the 5 day audit had "a significant interrogation of the systems". Maybe this helps inspectors to understand that the industry may have the same issue.
有意思的是关于6个月准备时间和5天的审计的声明“对系统有深入的讯问”。大概这有助于检查员理解受检查企业也会有相同的问题。
以下内容来自MHRA博客
Who Inspects the Inspectors?
谁检查检查员？
In October 2015 the MHRA was audited under the Joint Audit Programme (JAP) for EEA GMP Inspectorates.
2015年10月，MHRA接受了JAP对EEA的GMP检查组织的审计。
The audit programme is sponsored by the Heads of Medicines Agencies (HMA) and is focused solely on GMP, with management of the programme run by the Compliance Group which meets at the EMA and is supported by EMA staff.
审计计划是由HMA发起的，仅关注GMP方面，由法规符合组对计划进行管理，则EMA员工支持。
The two main drivers for the process are to verify equivalence and consistency of the implementation of European legislation and the practical application of GMP standards by national inspection agencies across the EEA and also to preserve confidence in the equivalence of EEA GMP systems to all member states and to EU Mutual Recognition Agreement (MRA) partner countries. The evaluation checklist adopted for the audit were borne out of the MRA with Health Canada, and these have been adopted by both HMA’s JAP and PIC/S (Pharmaceutical Inspection Cooperation Scheme) audit programme.
2个主要目的是核查EEA境内国家检查机构对欧洲法规实施和GMP标准实际应用的等同性和一致性，也保持EEA GMP体系在所有成员国和EU互认协议伙伴国等价性的置信度。审计中采用的评估检查表采纳的是加拿大MRA制订的，MHA的JAP和PIC/S检查组织也采纳的该表。
More details on the process can be found on the [url=]EMA website[/url]
更多详细的程序信息参见EMA网站。
European Medicines Agency, London 伦敦，EMAMHRA Audit 英国MHRA审计
The audit, from 12th to 16th October, was conducted by a team of 3 assessors; the assessment team consisting of senior inspectors from Finland, France and Spain. The audit was also observed by USFDA whose focus was on the JAP process itself rather than GMP systems within the MHRA. The observers were taking part under the Mutual Reliance Initiative looking to establish equivalence between Europe and US – more on this in a later blog post.
审计日期为10月12日至16日，由3位评审人员实施，评估团队由来自芬兰、法国和西班牙的资深检查员组成。美国FDA也作为观察员参与审计，其主要关注JAP流程本身，而不是MHRA的GMP体系。观察员在互认倡议下参与，主要是寻求在欧洲和美国之间建立等价性---稍迟有一份博客是关于此的。
This was a full scope re-audit, covering:
这是一次全范围再审计，包括：
1: legislative and regulatory: requirements and scope 法律和法规：要求和范围
2: regulatory directives and policies 法规指令和政策
3: GMP standards GMP标准
4: inspection resources 检查资源
5: inspection procedures 检查程序
6: inspection performance standards 检查实施标准
7: enforcement powers and procedures 实施能力和程序
8: alert and crisis systems 警戒和危机体系
9: analytical capability 分析能力
10: surveillance programme 监管计划
11: quality management system 质量管理体系
The detailed inspectorate processes and practices in the MHRA, associated with the headings above, were assessed with the aid of a checklist of 78 indicators plus an EC legislation transposition guide.
MHRA中详细的检查组织流程和规范，以及上述条款根据一份有78个以上指标的检查清单以及EC法律转化指南进行了评估。
The audit, as is normal practice, also included 2 on-site MHRA GMP inspections being observed, utilizing the JAP guidelines that describe the items normally necessary to initiate, plan, conduct, report upon and follow-up an observed inspection.
作为常规做法，审计还包括对2个现场MHRA的GMP审计进行观察，使用的是JAP指南，其中描述了一般启动、计划、实施、报告和跟踪一个检查所需的项目。
The 5 day audit required considerable resources from within the Agency, including the 2 on-site GMP inspection teams and those areas that support the inspectorate including Human Resources, Defective Medicines Report Centre, Inspectorate Policy, Inspection Action Group, Enforcement, the Licensing Authority, NIBSC, Medicines Testing scheme (including LGC)
该5天的审计调动了机构内可观的资源，包括2个现场GMP检查团队，以及支持检查组织的区域，包括人力资源、缺陷药品报告中心、检查方针、检查行动组、实施、持证机构、NIBSC、药品检测计划（包括LGC）。
How was it for you ? 对于你来说意味着什么？
It had been some time, 9 years, since the last JAP audit of the MHRA, and most of the current team were not directly involved last time around. So whilst we are very well aware of the responsibility we have when performing inspections, hosting an audit felt like a new experience. A negative outcome would have a significant impact on the functioning of the inspectorate and the reputation of the Agency. No pressure then!
自上次JAP审计MHRA以来已过了相当长的时间了，9年，目前大部分团队并没有直接参与上轮审计。因此尽管我们非常清楚我们实施检查的职责，但接受审计感觉像一种新经验。如果结果不好，会对检查组织的功能以及机构的声誉有很大影响。没有压力吧！
We had a 6 month preparation period, collecting the evidence, organising the inspections, and completing the self-assessment report that would be the basis of the audit. This included a significant amount of time mapping the EU Regulations and Directives to the UK medicines legislation to show that all had been transposed sufficiently.
我们有6个月的准备时间，收集证据、组织检查、完成自我评估报告，审计要依据这个报告。其中包括用了很多时间描绘EU法规和指令在英国药品法规中的表现，以显示所有法规都进行了足够的转换。
For the on-site audit, as hosts we wanted to ensure openness and transparency and so took the decision to present our evidence to the auditors by accessing our systems in the ‘live’ environment rather than downloading information and presenting offline. As the audit lasted 5 days there was a significant interrogation of the systems, and one or two ‘oops’ moments, but the lead auditor formally commending us for this approach.
对于现场审计，作为主人我们想要确保公开透明度，因此我们决定通过我们的体系在“直播”环境中呈交我们的证据给审计员，而不是下载信息然后离线呈交。由于审计持续了5天，因此对于系统是很深入的审问，一个或两个“哎哟”时刻，但主审官正式表扬了我们的这种方式。
Outcome 结论
At the close out meeting the assessment team confirmed that out of 78 indicators 73 were deemed to have been met with the other 5 deemed partially met. As a result of subsequent correspondence the assessment team concluded that ‘On the basis of the audit performed from October 12th to 16th, 2015, where equivalence has been demonstrated, the audit team is proposing that the Compliance Group considers the MHRA compliant with the JAP requirements.
在末次会议中，审计组确认78个指标中有73个是符合的，其它5个被判定为部分符合。通过后续的联系，审计组得出结论“根据2015年10月12-16日所实施的审计，证明具有等同性，审计组建议法规符合组考虑判定MHRA符合JAP要求。”
Based on this positive JAP outcome, the FDA started its assessment of MHRA. This was the first assessment of an EU member state for the Mutual Reliance Initiative. This assessment is now complete and the FDA’s outcome is awaited….
根据肯定的JAP结论，FDA开始对MHRA进行评估。这是第一次EU成员国进行互认倡议评估。此评估现在已完成，正等待FDA的结论……
来源：Julia Blog，感谢朱玉姣老师。
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发表于 2017-11-1 22:15:33
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