Alternative Microbiological Methods for Drug Quality Testing and their Implementation in Pharmacy Practice

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 metho...

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Bibliographic Details
Published in:Pharmaceutical chemistry journal 2020-11, Vol.54 (8), p.834-837
Main Authors: Roshchina, M. V., Gunar, O. V.
Format: Article
Language:English
Subjects:
Drugs
Medicine
Methods
Methods of Analysis and Process Control
Microbiology
Organic Chemistry
Pharmacology/Toxicology
Pharmacy
Quality management
Structure of Chemical Compounds
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Summary: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.
ISSN:0091-150X
1573-9031
DOI:10.1007/s11094-020-02283-y