FDA将规划现场检查新方法

20150402 ECA新闻：FDA将规划现场检查新方法  

2015-04-04 18:04:37|  分类： ECA新闻

GMP News
02/04/2015

http://www.gmp-compliance.org/enews_04785_FDA-plans-a-new-approach-to-facility-inspections.html

FDA plans a new approach to facility inspections

FDA将规划现场检查新方法

The "FDA Voice" is a Blog which has been developed by the US Agency to post current initiatives, presentation and views. In a recent post published on March 24, 2014 Howard Sklamberg (FDA’s Deputy Commissioner for Global Regulatory Operations and Policy) and Cynthia Schedar (Director of the Office of Compliance at FDA’s Center for Drug Evaluation and Research) discuss ideas to improve the quality of inspections.

FDA之声是一个博客，它由美国国家机构建立，用于贴出新的活动、展示和观点。在2014年3月24日（译者：这里原文有误，应为2015年）有一个贴子里，HOWARD SKLABERG（FDA全球法规运作和政策中心执行委员）和CYNTHIA SCHEDAR（FDA CDER合规办公室主任）讨论了提高检查质量的建议。

The two high level agency representatives discuss a new approach to facility inspections, "one that will not only note problems, but will also allow our inspectors to document where a firm’s quality management system exceeds what would be required to meet regulatory compliance. To put it simply: the inspections can yield also carrots, and not just sticks."

这两位高层次代表人物讨论了一个工厂检查新方法。“检查不仅要关注问题，也要允许我们的检查员记录公司的质量管理体系中好于合规要求的内容。简而言之：检查也要有萝卜，不止有大棒”。

The new approach will consider the findings by using them to plan the frequency of FDA Inspections. In addition, a good overall quality management system and culture might even lead to more flexibility for post-approval manufacturing changes. This was also a goal of ICH Q10 but regulators did not implement this idea yet. The new FDA proposal could be a starting point for providing regulatory flexibility to those companies who do more than what is needed.

新方法将考虑将缺陷情况用于规划FDA的检查频次。另外，一个好的全面质量管理体系和文化可能会使得该公司的上市后生产变更有更多弹性空间。这也是ICH Q10的目标，只是目前法规机构还没有实施而已。新的FDA建议可能是对所做工作比法规要求更多更好的公司进行弹性执法的一个起始点。

FDA is currently preparing a questionnaire to standardize inspections with the goal of "uniformly harvesting the kind of data that supports accurate measures of quality." The authors go on by saying "We believe that by improving the inspection process in this way, future “metrics” that define quality will be understood and aspired to by manufacturers — no matter where they are in the world."

FDA现在正在准备一个问卷，对检查进行标准化，其目标是“统一收集该数据的方法，用以支持对质量的准确度量”。作者说道“我们相信，采用这种方法来提高检查程序，将来生产商一定会理解“度量”这些定义的质量，并受到鼓舞---不管他们在世界的哪个地方”。

The new inspection approach might complement the current initiative to develop a FDA Guideline on Quality Metrics which is an intensively discussed initiative. Also other regulators around the world might consider this idea. Just recently the MHRA has published an update on their risk based inspection model. According to the MHRA approach to inspections questionnaires will be used to define the frequency as well. But the MHRA intends also to use the questionnaire once between inspection cycles to define the frequency.

新的检查方法可能会补充现在创新活动，建立起“FDA质量度量指南”，这个主题现在已被提出并广泛讨论。世界其它国家的法规人员可能也会考虑这个建议。最近MHRA公布了其基于风险的检查模式更新文件。根据“MHRA检查方法”，MHRA将使用问卷来决定现场检查的频次。但MHRA也倾向于只是在两次检查之间使用一次问卷来决定检查频次。

来源：http://zhuyujiao1972.blog.163.com/blog/static/986947272015346437416/

Thank you for sharing this in time.