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Greater certainty in monitoring 3 therapeutic medications is facilitated by new CRMs
Date:11/18/2009

es for determining compliance with USP compendial quality standards remain unchanged since, as stated on the Certificates of Analysis, the associated uncertainties are not used as part of the calculation value for quantitative USPNF applications.

The new CRMs will be used by the in vitro diagnostic device industry, which manufactures medical devices that examine specimens derived from the human body (e.g., blood or tissue donations) to provide information related to a physiological or pathological state or to monitor therapeutic measures. Requirements in Europe state that all measurements should be traceable to standards of a "higher metrological order," that is, more certain measurements. The International Organization for Standardization (ISO) states that, where possible, such standards should be CRMs. USP is the first global pharmacopeia to be ISO-certified as a producer of chemical CRMs.

"In releasing these three new CRMs, USP is meeting the needs of the multi-national in vitro diagnostic device industry," said William Koch, Ph.D., USP's chief metrology officer. "For these three products, a higher degree of certainty in measurement is extremely important. In Europe specifically, regulations support use of CRMs for in vitro diagnostic devices. However, this is useful for manufacturers of these medicines worldwide."


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Contact: Francine Pierson
fp@usp.org
301-816-8588
US Pharmacopeia
Source:Eurekalert

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