蒲公英 - 制药技术的传播者 GMP理论的实践者

搜索
查看: 2010|回复: 2
收起左侧

[数据调查及管理] outlier test and USP<1010>, Number of retests in OOS

[复制链接]
药徒
发表于 2019-5-10 10:35:05 | 显示全部楼层 |阅读模式

欢迎您注册蒲公英

您需要 登录 才可以下载或查看,没有帐号?立即注册

x
[ 本帖最后由 08111832187 于 2019-5-10 10:38 编辑 ]\n\n[ 本帖最后由 08111832187 于 2019-5-10 10:37 编辑 ]\n\nQuestion 2:
There is a new General Chapter <1010> in the USP. Will the statisticalrecommendations in <1010> be acceptable for the agency if they were part ofan internal procedure?
Answer:It would be OK for a firm to incorporate the procedures of <1010> except inthe cases where they are in conflict with the recommendations of our (FDA)guidances. For instance, FDA guidance recommends that outlier testing has avery limited role for chemical analysis, while USP <1010> gives quite anextensive discussion of the use of outlier tests.
The principle in our guidance remains the same: a result that is identifiedas a statistical outlier should not in itself lead to excluding it orinvalidating the result. It can be used as supporting evidence, along withother evidence developed in the investigation, that the result is invalid.

Question 3:
What's the agency's position regarding the methodologies of <1010>?
Answer:
FDA guidance makes no recommendations about the choice of statisticaloutlier tests to be used. It only says that the use of outlier tests shouldbe specified in an SOP and should be scientifically sound.
Q&As are from ECA news: https://www.GMP-compliance.org/gmp-news/fda-representatives-conduct-q-a-session-on-oos-results

"The maximum number of retests to be performed on a sample shouldbe specified in advance in a written standard operating procedure (SOP).The number may vary depending upon the variability of the particulartest method employed, but should be based on scientifically soundprinciples. The number of retests should not be adjusted depending onthe results obtained."It is to be welcomed that the document does not require a fixed numberof retests. However, an example given at the end of the guidance showshow, in the case of an inexplicable OOS result, seven retests help toprove that the first result did not reflect the true quality of the batch.This passage clearly refers back to the footnote of the Barr case of 1993!
number of retest is from ECA news: https://www.gmp-compliance.org/gmp-news/new-oos-guidance-by-fda


回复

使用道具 举报

药士
发表于 2021-7-25 10:15:12 | 显示全部楼层
"It is often important for the predefined retesting plan to include retests performed by an analyst other that the one who performed the original test. A second analyst performing a retest should be at least as experienced and qualified in the method as the original analyst."
Obviously, the FDA has taken into account industry comments saying that retests cannot always be performed by a second analyst, even if the second analyst is still considered very important.
请问这句话想表述的是什么意思呢?


回复

使用道具 举报

药士
发表于 2021-7-25 10:29:36 | 显示全部楼层
Question 2:
There is a new General Chapter <1010> in the USP. Will the statistical recommendations in <1010> be acceptable for the agency if they were part of an internal procedure?
Answer:
It would be OK for a firm to incorporate the procedures of <1010> except in the cases where they are in conflict with the recommendations of our (FDA) guidances. For instance, FDA guidance recommends that outlier testing has a very limited role for chemical analysis, while USP <1010> gives quite an extensive discussion of the use of outlier tests.
The principle in our guidance remains the same: a result that is identified as a statistical outlier should not in itself lead to excluding it or invalidating the result. It can be used as supporting evidence, along with other evidence developed in the investigation, that the result is invalid.
Question 3:
What's the agency's position regarding the methodologies of <1010>?
Answer:
FDA guidance makes no recommendations about the choice of statistical outlier tests to be used. It only says that the use of outlier tests should be specified in an SOP and should be scientifically sound.
其实outlier testing适用范围有限,可以用,但是担心的很多企业真的能做好相关统计学的支持嘛?

回复

使用道具 举报

您需要登录后才可以回帖 登录 | 立即注册

本版积分规则

×发帖声明
1、本站为技术交流论坛,发帖的内容具有互动属性。您在本站发布的内容:
①在无人回复的情况下,可以通过自助删帖功能随时删除(自助删帖功能关闭期间,可以联系管理员微信:8542508 处理。)
②在有人回复和讨论的情况下,主题帖和回复内容已构成一个不可分割的整体,您将不能直接删除该帖。
2、禁止发布任何涉政、涉黄赌毒及其他违反国家相关法律、法规、及本站版规的内容,详情请参阅《蒲公英论坛总版规》。
3、您在本站发表、转载的任何作品仅代表您个人观点,不代表本站观点。不要盗用有版权要求的作品,转贴请注明来源,否则文责自负。
4、请认真阅读上述条款,您发帖即代表接受上述条款。

QQ|手机版|蒲公英|ouryao|蒲公英 ( 京ICP备14042168号-1 )  增值电信业务经营许可证编号:京B2-20243455  互联网药品信息服务资格证书编号:(京)-非经营性-2024-0033

GMT+8, 2024-11-28 08:13

Powered by Discuz! X3.4运维单位:苏州豚鼠科技有限公司

Copyright © 2001-2020, Tencent Cloud.

声明:蒲公英网站所涉及的原创文章、文字内容、视频图片及首发资料,版权归作者及蒲公英网站所有,转载要在显著位置标明来源“蒲公英”;禁止任何形式的商业用途。违反上述声明的,本站及作者将追究法律责任。
快速回复 返回顶部 返回列表