FDA新的质量度量项目用来计划GMP检查

一沙一叶

美国食品药品管理局已经启动了一个新的检查体制。其中一个关键的亮点就是质量量度项目。
他们要求生产场地提供该场地“质量水平的数据”，这样FDA就可以通过这些数据看到他们质量体系的维护情况，并且判断他们的体系如何成功的影响医药产品的质量。
目前看来，FDA最关注的质量量度指标包括：
1.批次合格率
2.一次正确率=一年中至少有一个偏差的批次除以总的批次
3. 产品质量投诉率=工厂接到的总的投诉量除以总的生产批次
4. 无效的OOS率=最终无效的OOS测试除以测试总量
5. 产品年度审核及时率
6. 管理层参与-在年度审核报告上签字的最高级经理
  -性能问题1 产品APR中是否计算了关键质量属性的工艺能力或者性能指标
  -性能问题2 一些属性的工艺能力或者性能指标较差，是否要有CAPA
  -性能问题3 如果问题2是肯定的，那么什么工艺能力或者性能指标会导致CAPA？
7. CAPA率-根据APR启动的CAPA除以APR的数量。
FDA会用一年的时间学习试用质量量度。学习期后，如果不报告FDA的话，将是严重的合规问题。FDA在下个月将公布指南的草案。

The US Food and Drug Administration has initiated a comprehensive new organisation of its inspection activities. One of the key elements of this initiative is the Quality Metrics Program. This program will throw a complete new light on the compliance status of each manufacturing site. So far there were only two categories: GMP compliance or non-compliance. There was no benefit for industry to improve the overall quality as long as the manufacturing site was rated to be in GMP compliance.

The chances have been good that a non-compliance situation would not be discovered by FDA inspectors. The frequency of inspections - especially those in foreign countries - was not meeting internal FDA standards. Instead of inspections at least every two years, some facilities have not been inspected for a long period of time and thus have developed a "culture of non-compliance". When they finally were inspected, some major GMP deviations were discovered and caused comprehensive compliance actions such as FDA Warning Letters and Import Alerts. This has resulted in some serious drug shortages because medicinal products were only manufactured at very few manufacturing sites.

The FDA Quality Metrics initiative aims at asking each production site (APIs, medicinal products, Biotech, OTC etc) to provide data about the "quality level" in the manufacturing site. By this, FDA will be able to see from the data how well the quality system is maintained and how successful the quality system will affect the quality of the medicinal products.

At the 17th APIC Conference on APIs FDAs Russel Wesdyk presented details on how FDA will collect data from the companies. The Food and Drug Administration Safety and Innovation Act (FDASIA) Title VII, section 706 gives US FDA the authority to collect Quality Metrics. Over the last year a number of meetings have been organised in order to discuss potential Quality Metrics with stakeholders. As an outcome of these meetings the following Quality Metrics are of high interest for FDA:

Lot Acceptance Rate = the number of lots rejected by the establishment in a year divided by the number of lots attempted by the same establishment in the same year.

Right First Time Rate = the number of lots with at least one deviation by the establishment in a year divided by the number of lots attempted by the same establishment in the same year.

Product Quality Complaint Rate – the number of complaints received by the manufacturer of the product concerning any actual or potential failure of a unit of drug product to meet any of its specifications, divided by the total number of lots released by the manufacturer of the product in the same year.

Invalidated Out-of-Specification (OOS) Rate – the number of OOS test results invalidated by the establishment, or contracted establishment in a year divided by the total number of tests performed by the establishment in the same year.

Annual Product Review (APR) on Time Rate – the number of APRS generated within 30 days of annual due date at the establishment divided by the number of products produced at the establishment

Management Engagement – the most senior manager that signed each annual product review, reported as one of the following: (1) none specified, (2) line quality manager, (3) site operations manager, or (4) corporate executive manager.
- Performance Question 1 – A “yes” or “no” value of whether the establishment calculated a process capability or performance index for each critical quality attribute as part of that product’s APR.
- Performance Question 2 - A “yes” or “no” value of whether the establishment has policy requiring a CAPA at some lower process capability or performance index.
- Performance Question 3 – If “yes” to question 2 – what is the process capability or performance index that triggers a CAPA. If “no” to question 2 – please do not respond.

Corrective and Preventative Action (CAPA) Rate – the number of corrective or preventative actions that were initiated due to an APR, divided by the total number of APRs generated.

The FDA will use the Quality Metrics in a learning period of approx. one year. After that learning period serious compliance actions will be the consequence for not reporting to FDA. The next steps will happen very soon. The FDA is planning to publish the Draft Guide on Quality Metrics in the next months to come.
http://www.gmp-compliance.org/en ... MP-Inspections.html

yuansoul

又要疯了

yuansoul

又要疯了

绝恋亲纯

学习学习，

道路漫长黑暗

要求越来越严格了，等指南看看，谢谢沙版分享

一沙一叶

yuansoul 发表于 2015-1-22 21:29
又要疯了

疯什么啊  

syhorchid

谢谢分享

yuansoul

一沙一叶 发表于 2015-1-22 22:05
疯什么啊

风险评估的质量量度

沁人绿茶.

这些质量量度指标是建立的诚信的基础之上的，如果建立在技术处理或修饰、不体现的前提下，指标会非常的受看，上报也会皆大欢喜。但实际情况就不好说了。

一沙一叶

沁人绿茶 发表于 2015-1-23 08:00
这些质量量度指标是建立的诚信的基础之上的，如果建立在技术处理或修饰、不体现的前提下，指标会非常的受看 ...

确实，企业要骗你这些数据有什么用呢

凯普徐

企业具体应该怎么做呢？求解答

一沙一叶

凯普徐 发表于 2015-1-26 08:42
企业具体应该怎么做呢？求解答

下个月会出指南啊

海阳山山

重大进步，期望中国Cfda多学习，坐等指南。

海阳山山

补充一点，上报quality metrics比药品信息监管系统抓企业每日原辅料成品出入库等信息要靠谱多了

海阳山山

凯普徐 发表于 2015-1-26 08:42
企业具体应该怎么做呢？求解答

弄清楚每个指标的含义，按照要求准确上报数据。

小领主

逐步提升制药企业质量水平