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...
Main Authors: | , |
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Format: | Article |
Language: | Russian |
Published: |
NEICON ISP LLC
2020-12-01
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Series: | Ведомости Научного центра экспертизы средств медицинского применения |
Subjects: | |
Online Access: | https://www.vedomostincesmp.ru/jour/article/view/316 |