FDA已经准备好实施"质量衡量矩阵"(Quality Metrics Measures)

Michael-Hsu

Michael：FDA最新消息，与蒲友们分享。

小编按：经过两年的准备，FDA即将在今年底发布"质量衡量矩阵"的指南草案，在2015年正式生效，并在2016年开始对监管的药企要求提供质量数据，包括年度批量拒绝/接受率；第一时间正确率；产品质量的投诉，稳定性失败率，CAPA有效性比率。若没有质量管理信息化系统的帮助，是很难追踪分析如此大量的数据。您，准备好了吗？

After almost two years of discussion and analysis, the Food and Drug Administration is finalizing a proposal for collecting data from manufacturers to help measure the performance of manufacturing operations and the quality of resulting drugs and biologics. The agency hopes to issue draft guidance by the end of the year that will outline a set of metrics indicative of a company’s ability to produce high quality products consistently. FDA sees quality metrics as supporting a range of initiatives for addressing drug shortages and recalls and for assisting manufacturers in preventing situations that could undermine quality operations.

经过近两年的讨论和分析，FDA最终完成了确定为从制造商收集数据来衡量生产绩效和药品(包括生物制品)质量的方案。FDA希望在今年底能发布相关的指南草案，并在草案中列出一组能表示制药企业是否能持续性生产高质量产品的能力度量矩阵。FDA把质量矩阵作为后续一系列举措，包括解决药品短缺和召回和协助制造商在防止可能损害产品质量，的重要支撑。

The initial proposal is considering collection of data from manufacturers on annual lot rejection/acceptance rate; right-first-time rate; complaints received related to product quality; and invalidated out-of-specification results. To gain a broader measure of a manufacturer’s quality system, the draft plan also may examine on-time rate for annual product reviews, what level of management signs off on annual product reviews, whether an establishment calculates a process capability or performance index for critical quality attributes; and how an establishment’s  Corrective and Preventive Action (CAPA) program operates.

最初的草案是考虑从制造商采集下列数据：

• 年度批量拒绝/接受率；
• 一次正确率；
• 产品质量的投诉，
• 及OOS的发生率。
  
  

为了能更广泛的衡量一个制造商的质量体系，草案还可能检查：

• 年度产品回顾的准时率，
• 年度产品回顾是由哪一层级的主管签核，
• 是否建立工艺能力或性能指标的关键质量属性；
• 以及CAPA实施结果。
  
  

(小编按：试想，若没有稳定运行的质量管理信息化系统，如何能实时提供这些量化数据？？)

FDA aims to publish a draft guidance outlining this program by the end of the year, according to Russ Wesdyk, scientific coordinator at the Office of Strategic Programs in the Center for Drug Evaluation and Research (CDER), which has headed up this initiative under OSP director Theresa Mullin since it was announced in February 2013. An agency working group, which includes staff from OSP, the Office of Pharmaceutical Science, the Office of Compliance and FDA’s Office of Regulatory Affairs, is developing the program and will review comments on the draft guidance and hold public meetings to gain further input. The aim is to publish final guidance by the end of 2015 and initiate data collection in 2016. Manufacturers will have a year grace period to comply, but could face regulatory action after that.

药物评价和研究中心的战略计划办公室(CDER)的科学协调员Russ wesdyk表示，FDA计划在今年底发布指南草案。从2013年2月份宣布此计划以来，CDER就在OSP总监Theresa Mullin的领导下主持开展了线管工作。一组工作小组，成员来自OSP，the Offce of Pharmaceutical Science，the the Office of Compliance，和FDA's Office of Regulatory Affairs，一直在撰写草案，审查对于草案的意见，并举行公开的会议来获取更多的意见。最终目的是在20145发布正式的指南，并从2016年开始进行数据采集。制造商将有一年的宽限期，但之后就可能面临监管行动。

(小编按：剩不到两年的时间了，要出口产品到美国的药企们，您准备好了吗？)

Data will be collected for manufacturing sites and by products, Wesdyk explained at last week’s FDA/PQRI conference on evolving product quality. FDA will issue overall results for industry, and also provide each manufacturer with a confidential score that then can be compared to industry averages – somewhat similar to SAT scores, in that the individual will see a specific score and also how it fits overall results.

数据将由生产车间依照产品来采集，Wesdyk在上周FDA/PQRI的产品质量演化会议上表示：FDA将发步行业的整体结果，并提供各制造商保密分数，用于比对行业的平均水平 – 这一做法有些类似SAT成绩，个别制造商将看到自己的得分，和在行业里的位置。

In developing the program, the FDA working group has solicited and reviewed white papers from manufacturers on what data they currently collect and what metrics they consider most valuable. In submitting proposals to FDA, the International Society for Pharmaceutical Engineers (ISPE), the Parenteral Drug Association (PDA), the Pharmaceutical Research and Manufacturers of America (PhRMA), the Biotechnology Industry Organization (BIO) and the Generic Pharmaceutical Association (GPhA) have addressed different aspects of this broad initiative, clarified definitions of key terms, and emphasized the need to take a balanced approach to assessing quality production. A second PDA workshop in December will further examine the attributes and measures of a “quality culture.”  Ideally, this initial set of metrics will lay the basis for further harmonization of quality standards on a global basis.

在撰写草案的过程中，FDA工作组也听取和审查来自制造商的白皮书，以了解目前制造商已经在采集什么样的数据，和哪些是制造商认为最有价值的数据。国际制药工程协会(ISPE)，注射药物协会（PDA），美国药品研究与制造商协会（PhRMA），生物技术产业组织（BIO）和仿制药协会（GPHA）在提交给FDA的建议书中已经提出计划的各个需考虑的层面，阐明了关键术语的定义，并强调需要采取一个平衡的方式来评估产品质量。在12月份举办的PDA研讨会将进一步检视“质量文化“的属性和度量方法。在理想情况下，这组质量矩阵的度量指标将会成为未来协调统一全球药品质量标准的基础。

石头968

矩阵是很好的管理模式

一沙一叶

名头很大，静观其变

道路漫长黑暗

学习一席啊

红茶.

从上面看的，需要提供的数据来看，也没什么吧？这些数据药厂都没有？

胜利者

是否可以理解为关键质量参数的趋势统计、分析？

愚公想改行

正在关注此动态！欢迎楼主老师能及时上传相关动态信息。

leehwadong

中心思想是通过统计发现深层次问题。过程能力分析、时间序列分析等高级的统计方法应用有助于发现深层次的问题。

冰城

acmilanhm 发表于 2014-11-5 09:42
从上面看的，需要提供的数据来看，也没什么吧？这些数据药厂都没有？

造假的位数也不少

冰城

这个国内很多企业已经有做过的了，虽然没有非常专业化，不过数据的统计分析一直在进行

liuqygood2005

学习学习

怀谷

学习了，谢谢！

Michael-Hsu

FDA-质量量度计划中提到的量度，很多药厂都有做，问题是这些都是事后的统计分析，等分析出来问题都已经发生了，如何能够做到实时的监控，类似仪表板的方式，能即时看到这些量度的变化，及早进行预防措施，这是难度所在。

北重楼

学习了，看来以后得多学习一下统计学知识了

彩虹

学习了{:soso_e181:}

yanzhengren

谢谢分享。

lenovol421

谢谢分享，学习学习

浪漫童话

谢谢老师的分享