Transfer of methods, and parameters of validation/verification

Transfer of methods, and parameters of validation/verification

The article analyses foreign and national recommendations on transfer of methods. It substantiates the need to adequately reproduce test methods that introduce a specific analytical procedure in testing laboratories - in order to be able to give a reliable assessment of the quality of substances and...

Full description

Bibliographic Details
Main Author: S. I. Kuleshova
Format: Article
Language:Russian
Published: Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’) 2018-02-01
Series:Регуляторные исследования и экспертиза лекарственных средств
Subjects:
аналитическая методика
лекарственное средство
перенос (трансфер) методики
валидация
верификация
передающая лаборатория
принимающая лаборатория
параметры валидации/верификации
analytical procedure
medicine
transfer of method
validation
verification
sharing laboratory
receiving laboratory
validation/verification parameters
Online Access:https://www.vedomostincesmp.ru/jour/article/view/122

Internet

https://www.vedomostincesmp.ru/jour/article/view/122

Similar Items