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