Transfer of methods, and parameters of validation/verification

• Main Author: S. I. Kuleshova
• Format: Article
• Language: Russian
• Published: OOO “Vashe Tsifrovoe Izdatelstvo” 2018-02-01
• Series: Ведомости Научного центра экспертизы средств медицинского применения
• 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

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 dosage forms. The article gives examples of a successful analytical method transfer, describes ways of transferring analytical procedures, cases when the transfer of method is not needed, and validation/verification parameters that are used to check whether the method is suitable for a particular laboratory. It also gives examples of validation parameters that are used in verification of pharmacopoeial methods, which are chosen based on the type of method and the tested parameter.