Transfer of Analytical Procedures (Review)
Introduction. This article reviews main steps of the transfer of analytical procedures following the recommendations of the Russian and foreign regulatory bodies. Each step provides thorough evaluation of an analytical procedure, checks its current validation status and readiness of the receiving la...
| Main Authors: | , , |
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| Format: | Article |
| Language: | Russian |
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LLC Center of Pharmaceutical Analytics (LLC «CPHA»)
2020-08-01
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| Series: | Разработка и регистрация лекарственных средств |
| Subjects: | |
| Online Access: | https://www.pharmjournal.ru/jour/article/view/786 |
| _version_ | 1797874998092759040 |
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| author | Yu. A. Starchak M. V. Gavrilin N. V. Shineva |
| author_facet | Yu. A. Starchak M. V. Gavrilin N. V. Shineva |
| author_sort | Yu. A. Starchak |
| collection | DOAJ |
| description | Introduction. This article reviews main steps of the transfer of analytical procedures following the recommendations of the Russian and foreign regulatory bodies. Each step provides thorough evaluation of an analytical procedure, checks its current validation status and readiness of the receiving laboratory. Each step of the process is crucial for a reliable transfer. The article contains examples of formatting of analytical procedures to be revalidated, characteristics of test samples, reference standards of impurities. The authors described procedures to be transferred depending on the dosage form.Text. The aim of this article is to review possible types of the transfer, including a transfer waiver, and main components of a transfer protocol following the information from the Russian and foreign literature sources.Conclusion. Reliability and reproducibility of analytical method data are crucial as they form the basis for a decision-making process. Therefore a procedure should be capable of producing consistent data. |
| first_indexed | 2024-04-10T01:39:43Z |
| format | Article |
| id | doaj.art-f083fe20fc334876968cf6671018c576 |
| institution | Directory Open Access Journal |
| issn | 2305-2066 2658-5049 |
| language | Russian |
| last_indexed | 2024-04-10T01:39:43Z |
| publishDate | 2020-08-01 |
| publisher | LLC Center of Pharmaceutical Analytics (LLC «CPHA») |
| record_format | Article |
| series | Разработка и регистрация лекарственных средств |
| spelling | doaj.art-f083fe20fc334876968cf6671018c5762023-03-13T09:14:01ZrusLLC Center of Pharmaceutical Analytics (LLC «CPHA»)Разработка и регистрация лекарственных средств2305-20662658-50492020-08-019318218710.33380/2305-2066-2020-9-3-182-187761Transfer of Analytical Procedures (Review)Yu. A. Starchak0M. V. Gavrilin1N. V. Shineva2ФГБУ «Научный центр экспертизы средств медицинского применения» Минздрава России (ФГБУ «НЦЭСМП» Минздрава России)ФГБУ «Научный центр экспертизы средств медицинского применения» Минздрава России (ФГБУ «НЦЭСМП» Минздрава России)ФГБУ «Научный центр экспертизы средств медицинского применения» Минздрава России (ФГБУ «НЦЭСМП» Минздрава России)Introduction. This article reviews main steps of the transfer of analytical procedures following the recommendations of the Russian and foreign regulatory bodies. Each step provides thorough evaluation of an analytical procedure, checks its current validation status and readiness of the receiving laboratory. Each step of the process is crucial for a reliable transfer. The article contains examples of formatting of analytical procedures to be revalidated, characteristics of test samples, reference standards of impurities. The authors described procedures to be transferred depending on the dosage form.Text. The aim of this article is to review possible types of the transfer, including a transfer waiver, and main components of a transfer protocol following the information from the Russian and foreign literature sources.Conclusion. Reliability and reproducibility of analytical method data are crucial as they form the basis for a decision-making process. Therefore a procedure should be capable of producing consistent data.https://www.pharmjournal.ru/jour/article/view/786трансферперенос аналитических методикгосударственная фармакопеясравнительное испытаниетрансферпротокол трансфераотчет трансфера |
| spellingShingle | Yu. A. Starchak M. V. Gavrilin N. V. Shineva Transfer of Analytical Procedures (Review) Разработка и регистрация лекарственных средств трансфер перенос аналитических методик государственная фармакопея сравнительное испытание трансфер протокол трансфера отчет трансфера |
| title | Transfer of Analytical Procedures (Review) |
| title_full | Transfer of Analytical Procedures (Review) |
| title_fullStr | Transfer of Analytical Procedures (Review) |
| title_full_unstemmed | Transfer of Analytical Procedures (Review) |
| title_short | Transfer of Analytical Procedures (Review) |
| title_sort | transfer of analytical procedures review |
| topic | трансфер перенос аналитических методик государственная фармакопея сравнительное испытание трансфер протокол трансфера отчет трансфера |
| url | https://www.pharmjournal.ru/jour/article/view/786 |
| work_keys_str_mv | AT yuastarchak transferofanalyticalproceduresreview AT mvgavrilin transferofanalyticalproceduresreview AT nvshineva transferofanalyticalproceduresreview |