Revised Out of Specification (OOS) Guidance | USFDA Guidance | OOS Guidance May 2022

Описание к видео Revised Out of Specification (OOS) Guidance | USFDA Guidance | OOS Guidance May 2022

USFDA has published a revised version of Guidance for Out of specification investigation in May 2022.
The USFDA Guidance provides details regarding steps for investigation the OOS including the Phase-I Laboratory Investigation, Phase-II Full Scale Investigation, responsibility of analyst, responsibility of supervisor.
The Guidance also provides details regarding retesting, resampling and averaging of test results with their appropriate and inappropriate use.

Комментарии

Информация по комментариям в разработке

Похожие видео