USP Assays
Where applicable, Microtest tests pharmaceutical and biopharmaceutical products according to requirements set forth in the United States Pharmacopeia (USP).
Various other regulatory agencies — including the U.S. Food and Drug Administration (FDA), the International Organization for Standardization (usually called the ISO), and the Association for Advancement of Medical Instrumentation (AAMI) — recognize the USP method as, in effect, the highest standard. Certainly in the U.S.A., USP requirements make up regulators’ official first action method.
USP guidelines steer our testing of given samples from a production run of a pharmaceutical product or package; from a raw material; or from a pharmaceutical processing facility. The aim: to determine if these samples exhibit given properties that render the tested materials suitable or unsuitable for distribution to the public.
The Microtest staff of highly trained, experienced microbiologists provides the following USP assays:
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