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...
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| Format: | Article |
| Language: | Russian |
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NEICON ISP LLC
2018-02-01
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| Series: | Ведомости Научного центра экспертизы средств медицинского применения |
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| Online Access: | https://www.vedomostincesmp.ru/jour/article/view/122 |
| Summary: | 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. |
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| ISSN: | 1991-2919 2619-1172 |