FDA对于留样和委托检验的要求

楠人K2已苍孙

各位老师，最近在比对生产质量规范和指导原则与820的关系，发现820没有对留样、委托检验进行规定，哪位老师指点一下，感恩

机智鼠

在药学和医疗器械领域，关于留样和委托检验的要求，FDA的21 CFR 320.38 (c)条款提供了明确的指导。该条款规定了生物利用度（BA）和生物等效性（BE）研究中样品的保留数量和处理方式。尽管820部分没有直接提及留样和委托检验，但21 CFR 320.38 (c)的规定为相关活动提供了必要的法规遵循。此外，药品生产企业应确保其质量管理体系符合FDA的全面要求，包括适当的留样和委托检验程序，以保证产品质量和合规性。

【鼠鼠还在学习中，内容仅供参考（药搭GMP软件提供技术支持）】

楠人K2已苍孙

机智鼠 发表于 2025-1-15 09:49
在药学和医疗器械领域，关于留样和委托检验的要求，FDA的21 CFR 320.38 (c)条款提供了明确的指导。该条款规 ...

谢谢老师，感恩

wolflee11

(c) Each reserve sample shall consist
of a sufficient quantity to permit FDA
to perform five times all of the release
tests required in the application or
supplemental application.
(d) Each reserve sample shall be adequately
identified so that the reserve
sample can be positively identified as
having come from the same sample as
used in the specific bioavailability
study.
(e) Each reserve sample shall be
stored under conditions consistent
with product labeling and in an area
segregated from the area where testing
is conducted and with access limited to
authorized personnel. Each reserve
sample shall be retained for a period of
at least 5 years following the date on
which the application or supplemental
application is approved, or, if such application
or supplemental application
is not approved, at least 5 years following
the date of completion of the
bioavailability study in which the sample
from which the reserve sample was
obtained was used.

conansxy

楠人K2已苍孙 发表于 2025-1-15 10:10
谢谢老师，感恩

320是药品的，不是器械的；器械应该是没有明确关于留样的要求，你可以自己定义

楠人K2已苍孙

conansxy 发表于 2025-1-15 11:00
320是药品的，不是器械的；器械应该是没有明确关于留样的要求，你可以自己定义

我之前查的也是好像是药品，就是没找到针对医疗器械的说法，还在找