21 CFR part 11求翻译，求指点

药半仙

在21 CFR part11 中，有一个词始“predicate rule”终不懂，不知道翻译成中文是什么意思。

这个rule到底指的是哪些rule？

求大神指点。

radiopharm

Predicate rules are the requirements that can be found in part 21 CFR Food and Drugs regulations. They are basically promulgated under the authority of the Food Drug and Cosmetic Act or under the authority of the Public Health Service Act. The most well-known FDA regulations are the GMP regulations.

预知子

没有上下文，很难判断啊

eCTD-Collietech

新手来学习

药半仙

linbinbin 发表于 2018-2-27 08:17
没有上下文，很难判断啊

D:\yanyongdong\Desktop\微信图片编辑_20180227104538.jpg

药半仙

请查看图片。

jaysun

意思是，参考GMP中用于纸质文档要求

cnosema

goldenhawk 发表于 2018-2-27 10:49
请查看图片。

2楼是这个词的完整定义

beiwei5du

我个人的理解是关于记录要求的所有法规（除了Part 11）都可以叫做predicate rules（主要是颁布这些法规的时候，前期主要是适用于纸质记录的）.

Predicate Rules: Definition
A predicate rule is any FDA regulation that requires companies to maintain certain records and submit information to the agency as part of compliance. Examples can be found in in GxP regulations such as GLP (Good Laboratory Practices), GCP (Good Clinical Practices), and CGMP (Current Good Manufacturing Practices).

Although predicate rules were originally meant to apply to paper records (which required handwritten signatures), these rules remain applicable even when you use electronic records and signatures. In this case, 21 CFR 11 then becomes an additional requirement for e-records and signatures. Part 11 requirements are not meant to replace or override other FDA (GxP, GLP, GCP, CGMP) regulations pertaining to signatures and records.

Understanding Predicate Rules Found in GxP, GLP, GCP, CGMP, Key to Compliance with FDA 21 CFR Part 11

月色血风暴

非常好，谢谢！

月色血风暴

非常好，谢谢！

小金库

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