Transfer of methods, and parameters of validation/verification

Ведомости Научного центра экспертизы средств медицинского применения

卷:7

S. I. Kuleshova¹ 

[1] Scientific Centre for Expert Evaluation of Medicinal Products;

关键词: 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;   

DOI  :  

来源: DOAJ

【 摘 要 】

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.

【 授权许可】

Unknown