AOAC is examining a proposal to revise “Appendix J: AOAC INTERNATIONAL Methods Committee Guidelines for Validation of Microbiological Methods for Food and Environmental Surfaces” of the Official Methods of AnalysisSM (OMA) compendium. AOAC activities encompass new industries and techniques representing complex analytes and matrices, emergence of novel and highly virulent pathogens, and newly developed technologies since the guidelines were first developed in 2002. The document, which was last updated in February 2012, will be revised to reflect today’s environment and provide guidance on criteria and expectations for method authors developing methods for these new analytes and technologies.
“It’s been over a decade since the guidelines have been updated, and technologies have advanced enormously over the years,” said Patrick Bird of bioMérieux. “Today, AI and machine learning can impact validation processes. There is a need for modernization of the current microbiology guidelines.”
Appendix J is referenced in global validation standards, such as ISO 16140-2:2016. Study designs and statistical analysis found in Appendix J are harmonized with the U.S. Food and Drug Administration’s (FDA) requirements for validation of microbiological methods.
“ISO 16140-2 is up for revision, which is also good timing to revise and harmonize the AOAC microbiological validation guidelines to maintain its fitness-for-purpose and relevance to the global analytical community,” said Bird, a project leader for revising the appendix.
Revisions of Appendix J should focus on defining requirements for AOAC Performance Tested MethodsSM (PTM) and OMA programs, international harmonization (matrix categorization, inclusivity/exclusivity, confirmatory/identification methods, viruses and parasites), and method comparison updates (quantitative analysis, statistical analysis, semiquantitative methods, inclusivity/exclusivity).
In addition, it will be important to examine integration of technical bulletins, application of AOAC Standard Method Performance Requirements (SMPRs®), cannabis and emerging industry segments, advancements in technology, AI/machine learning, molecular biomarker analysis, and potentially verification guidelines.
If you are interested in supporting the initiative, contact scienceprograms@aoac.org.
