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Does International Harmonization of the USP Microbial Limits Tests Require Re-Validation of Finished Product Tests? | IVT

The final versions change the requirement for validation to “verification of suitability of the method” The Microbial Limits Tests are a collection of tests and specifications.  United States Pharmacopeia (USP)-National Formulary (NF) chapter <61> looks to bioburden testing (total aerobic microbial count [TAMC] and total yeast and mold count [TYMC]) while USP <62> describes tests for the “absence of” seven different specified organisms.  USP <1111> is an informational chapter for setting microbial quality standards for non-NF materials. USP <61> describes...

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