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 |
| Subjects: | |
| Online Access: | https://www.vedomostincesmp.ru/jour/article/view/122 |
| _version_ | 1797199047784660992 |
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| author | S. I. Kuleshova |
| author_facet | S. I. Kuleshova |
| author_sort | S. I. Kuleshova |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-07T19:17:55Z |
| format | Article |
| id | doaj.art-3f0426e7937a4b5281963eec94400256 |
| institution | Directory Open Access Journal |
| issn | 1991-2919 2619-1172 |
| language | Russian |
| last_indexed | 2024-04-24T07:09:33Z |
| publishDate | 2018-02-01 |
| publisher | NEICON ISP LLC |
| record_format | Article |
| series | Ведомости Научного центра экспертизы средств медицинского применения |
| spelling | doaj.art-3f0426e7937a4b5281963eec944002562024-04-21T11:46:32ZrusNEICON ISP LLCВедомости Научного центра экспертизы средств медицинского применения1991-29192619-11722018-02-01727780120Transfer of methods, and parameters of validation/verificationS. I. Kuleshova0Scientific Centre for Expert Evaluation of Medicinal ProductsThe 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.https://www.vedomostincesmp.ru/jour/article/view/122аналитическая методикалекарственное средствоперенос (трансфер) методикивалидацияверификацияпередающая лабораторияпринимающая лабораторияпараметры валидации/верификацииanalytical proceduremedicinetransfer of methodvalidationverificationsharing laboratoryreceiving laboratoryvalidation/verification parameters |
| spellingShingle | S. I. Kuleshova Transfer of methods, and parameters of validation/verification Ведомости Научного центра экспертизы средств медицинского применения 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 |
| title | Transfer of methods, and parameters of validation/verification |
| title_full | Transfer of methods, and parameters of validation/verification |
| title_fullStr | Transfer of methods, and parameters of validation/verification |
| title_full_unstemmed | Transfer of methods, and parameters of validation/verification |
| title_short | Transfer of methods, and parameters of validation/verification |
| title_sort | transfer of methods and parameters of validation verification |
| topic | 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 |
| url | https://www.vedomostincesmp.ru/jour/article/view/122 |
| work_keys_str_mv | AT sikuleshova transferofmethodsandparametersofvalidationverification |