Special Project Method Development and Method Validation Analytical Track

提高…的能力和容量

Increasing the Capability and Capacity of Microbiological and Chemical Testing to Support an Integrated Food Defense and Food Safety System Special Projects Discipline, Method Development and Method Validation Analytical Track Project Summary / Abstract Method development and method validation are vital to the production of new testing assays and providing defensible methods to support any corresponding regulatory action, respectively. Common prohibitors of successful single laboratory validation (SLV) and multi-laboratory validation (MLV) studies are that of poor design of experiment leading to unusable validation data or the high cost of coordinating multiple laboratories and standardizing the method across national or even international lines. In both cases these studies require a large investment of time for each participating laboratory. Nevertheless, the benefits of a validated study are worth the costs involved. The Ohio Department of Agriculture (ODA) Consumer Protection Laboratory (CPL) thus proposes in the first project period to participate in a multi-laboratory validation (MLV) study for the FDA Elemental Analysis Manual method EAM 4.12, “Mass Spectrometric Determination of 18 Elements in Bottled Water.” ODA-CPL will supply all necessary reagents, experienced personnel and logistical support to ensure their laboratory portion of work is complete. ODA-CPL will participate in any communications related to the MLV. In future project periods, ODA-CPL intends to continue method development and method validation activities and applying to perform studies for microbiological or chemical methods depending on FDA’s priorities so long as ODA-CPL’s assets and workflow are compatible.