An informational-analytical review of alternative microbiological methods for quality testing of pharmaceutical products is presented. The expediency and peculiarities of implementing these methods in pharmacy practice for routine testing are considered. General approaches to validation of new methods are described. The new methods are compared with classical methods in all implementation stages. Foreign regulations on the selection of validation parameters and their acceptance criteria are analyzed.
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The work was performed in the framework of State Task No. 056-00003-20-00 to SCEEMP, Ministry of Health of Russia for applied scientific research (State Acct. No. NIR AAAA-A18-118021590049-0).
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Translated from Khimiko-Farmatsevticheskii Zhurnal, Vol. 54, No. 8, pp. 35 – 39, August, 2020.
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Roshchina, M.V., Gunar, O.V. Alternative Microbiological Methods for Drug Quality Testing and their Implementation in Pharmacy Practice. Pharm Chem J 54, 834–837 (2020). https://doi.org/10.1007/s11094-020-02283-y
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DOI: https://doi.org/10.1007/s11094-020-02283-y