20140917 ECA新闻：客诉和召回：新EU-GMP第8章公布

20140917 ECA新闻：客诉和召回：新EU-GMP第8章公布  

2014-09-19 21:08:47|  分类： ECA新闻 |  
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GMP News
17/09/2014

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Complaints and Recalls: new EU-GMP Chapter 8 published

客诉和召回：新EU-GMP第8章公布

The European Commission has published the final Chapter 8 of the EU Guidelines for GMP (Complaints, Quality Defects and Product Recalls). The chapter has been revised completely. Whereas the current one has less than two pages focusing on complaints and recalls only, the revision is six pages long, defining expectations for:

欧洲委员会已公布了EU GMP指南的第8章最终版（客诉、质量缺陷和产品召回）。该章已进行了完全的修订。目前的版本用了不止2页的篇幅关注了投诉和召回的问题，修订版本共有6页，给出了以下要求：

Personnel and Organisation 人员和机构 Procedures for handling and investigating complaints including possible quality defects 处理和调查客诉，包括可能的质量缺陷，的程序 Investigation and Decision Making 调查和做出决定 Root Cause Analysis and Corrective and Preventative Actions 根本原因分析和纠正和预防措施 Product Recalls and other potential risk-reducing actions
• 产品召回和其它潜在降低风险的措施
  

Throughout its chapters, the new version of Chapter 8 introduces Quality Risk Management principles and appropriate root cause analysis work when investigating quality defects and complaints. The scope includes complaints including quality defects (this is also new) and recall issues with respect to marketed medicinal products and investigational medicinal products (IMPs) that have been released to clinical trials. The new chapter 8 is better aligned with the wording of Directive 2003/94/EC with regard to when a quality defect/complaint should be reported to the competent authority.

在整个章节中，新版本的第8章在质量缺陷调查和客诉中引入了质量风险管理原则，和适当的根本原因分析工作。范围包括客诉及质量缺陷（这也是新引入的）及与上市销售药品和放行用于临床试验的临床试验用药品（IMP）的召回问题。新的第8章更好地反映了指令2003/94/EC中关于质量缺陷/客诉应向药监当局报告的要求。

Besides investigating and determining the cause(s) of quality defects/complaints, the revised chapter 8 also wants to ensure that appropriate corrective and preventative actions are put in place to avoid recurrence of the issue. CAPA has already been introduced in the revision of chapter 1 and is now also be recognised in chapter 8. The effectiveness "should be monitored and assessed".

除了调查和决定质量缺陷/客诉原因外，修订后的第8章还希望保证适当的纠正和预防措施，并实施以避免问题的重复发生。第1章修订时，已引入了CAPA的概念，现在在第8章中也提及了，谈到其有效性“应进行监控和评估”。

When it comes to product recalls, the new chapter also addresses risk mitigation and risk-based thinking into the recall decision-making process. In this context, the Manufacturer and Marketing Authorisation Holder shall ensure continuity of supply for critical medicinal products where alternative products may not be readily available. Consultation with the Competent Authority is inevitable.

在讲到产品召回时，新的第8章里也说明了在做出召回决定的过程中，应考虑风险转移和根据风险的思维。在此处，如果可替代的药品可能不容易获得时，生产商和上市许可持有人应保证关键药品的持续供应，这时不可避免地要与听取药监当局的意见。

The Qualified Person (QP) who is involved in the certification for release of the concerned product will play an important role. If the QP is not directly responsible for managing complaint and quality defect investigations and for deciding the measures to be taken, he or she "should be made formally aware of any investigations, any risk-reducing actions and any recall operations, in a timely manner". For all respective actions like for example handling, reviewing and investigating complaints, sufficient personnel and resources should be made available.

负责放行相关产品的授权人（QP）要起到重要作用。如果QP不直接负责管理客诉和质量缺陷调查，及决定所需采取的措施，则他或她“应被及时地正式告知所有调查和降低风险的措施，以及所有召回操作”。应有足够的人手和资源用于所有相关措施，例如处理、审核和调查客诉。

The revised chapter details the requirements for written procedures like SOPs. They should at least address the following:

修订后的第8章对书面程序如SOP给出了详细要求。其中应至少包括以下内容：

The description of the reported quality defect. 所报告的质量缺陷的描述 The determination of the extent of the quality defect. 质量缺陷范围的确定 Handling of samples 样品处理 The assessment of the risk(s) posed by the quality defect. 质量缺陷所带来风险的评估 How decisions and assessments are made 如何做出决定和评估 Notification to the relevant authorities and other internal and external communications 通知相关药监当局和其它内部和外部沟通 Root cause analysis and CAPAs.   
• 根本原因分析和CAPA
  

There should also be established written procedures in relation to recall activities or the implementation of any other risk-reducing actions, so that recall operations can be initiated promptly and at any time.

还要建立与召回活动和实施所有其它降低风险措施的书面程序，这样召回操作方可在任何时间及时启动。

So called Mock Recalls are now also described in more detail. Evaluations of the effectiveness "should extend to both within office-hour situations as well as out-of-office hour situations and, when performing such evaluations, consideration should be given as to whether mock-recall actions should be performed. This evaluation should be documented and justified. "

所谓的“模拟召回”现在也描述的更详细了。有效性评估“应延伸至工作时间内情形以及工作时间外的情形，如果进行这样的评估，还要考虑是否需要实施模拟召回。该评估应书面记录并论述其合理性”。

Overall, the goal is to achieve information-based and scientific decisions in relation to risk-mitigating actions. It should also be highlighted that there may be more than one cause associated with a quality defect/complaint. However all likely causes should be thoroughly investigated leading to more effective preventative actions being identified and put in place.

总体来说，修订的目的是根据信息，做出与风险转移措施相关的科学决定。还要强调的是一个质量缺陷/客诉可能会有不止一个原因。但是，所有可能的原因均应进行彻底调查，以制订并实施更多有效的预防措施。

To find more details please see the final Chapter 8: Complaints, Quality Defects and Product Recalls.

更多细节参见EU GMP第8章：客诉、质量缺陷和产品召回最终版。

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