Validation Parameters as Applied to Methods for Quantification of Microorganisms in Medicinal Products
Validation/verification of microbiological methods is a prerequisite for quality control of non-sterile drugs. However, the use of existing procedures for validation/verification of analytical methods is challenging, since a number of factors, such as microorganism distribution in the sample, cell m...
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| Main Authors: | , |
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| Format: | Article |
| Language: | Russian |
| Published: |
Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’)
2020-12-01
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| Series: | Регуляторные исследования и экспертиза лекарственных средств |
| Subjects: | |
| Online Access: | https://www.vedomostincesmp.ru/jour/article/view/316 |
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