Foods Program Methods Validation Processes and Guidelines

FDA Foods Program Analytical Laboratory Methods are governed by processes outlined in the Methods Development, Validation, and Implementation Program (MDVIP) Standard Operating Procedures. The processes were developed under the former Office of Foods and Veterinary Medicine (OFVM) and are now managed by the FDA Foods Program Regulatory Science Steering Committee (RSSC), which is made up of members of FDA’s Center for Food Safety and Applied Nutrition (CFSAN), Office of Regulatory Affairs (ORA), Center for Veterinary Medicine (CVM), and National Center for Toxicological Research (NCTR). The MDVIP commits its members to collaborate on the development, validation, and implementation of analytical methods to support the Foods Program regulatory mission. One of the main goals of the MDVIP is to ensure that FDA laboratories use properly validated methods, and where feasible, methods that have undergone multi-laboratory validation (MLV). The process of generating, validating, and approving such methods is managed separately for the chemistry and microbiology disciplines through Research Coordination Groups (RCGs) and Method Validation Subcommittees (MVS). RCGs take overall leadership of the program and provide a coordinating role in developing and updating guidelines and posting methods. The MVSs are responsible for approving validation plans and evaluating validation results, as well as playing a major role in updating the validation guidelines. Validation guidelines for chemical, microbiological, and DNA-based methods have been developed under the MDVIP and are listed below. Acceptance criteria for confirmation of identity of chemical residues using exact mass data have also been developed by members of the MDVIP.