Comparative overview of European Pharmacopoeia and United States Pharmacopoeia requirements for validation of alternative microbiological methods
Pharmacopoeial microbiological methods, foundational to the functioning of the pharmaceutical facilities, are limited by the time required for analysis, which is associated with significant costs. To overcome this limitation, alternative (rapid) microbiological methods (ARMMs) are encouraged due t...
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| Main Authors: | , , , |
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| Format: | Article |
| Language: | English |
| Published: |
University Ss Cyril and Methodius in Skopje, Faculty of Pharmacy and Macedonian Pharmaceutical Association
2025-06-01
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| Series: | Makedonsko Farmacevtski Bilten |
| Subjects: | |
| Online Access: | https://bulletin.mfd.org.mk/volumes/Volume%2071_1/71_1_010.pdf |
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| Summary: | Pharmacopoeial microbiological methods, foundational to the functioning of the pharmaceutical facilities, are limited by the time
required for analysis, which is associated with significant costs. To overcome this limitation, alternative (rapid) microbiological methods
(ARMMs) are encouraged due to faster execution, easier monitoring and automation while improving accuracy, specificity, sensitivity, and
precision. This article presents an overview of the requirements for demonstrating equivalency or superiority of ARMMs to the established
Pharmacopoeia methods, as recommended by Ph. Eur. and USP. Steps that should be taken to evaluate candidate alternative methods, from
selection of analytical technology to qualification of the method with actual product are described. Special emphasis is given on the validation process for the ARMMs and the validation criteria that need to be evaluated in order to prove method suitability and equivalency
to Pharmacopoeia methods. |
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| ISSN: | 1409-8695 1857-8969 |