Tools for Assuring Data Quality in Natural Products Studies: The NIH/ODS Analytical Methods and Reference Materials Program (AMRM)

Assessing the quality of natural products can be a challenge. Most definitions of quality start with assurance that biomass has been properly identified and ranges through proper sanitation and absence of deleterious substances such as pesticides, toxic elements, natural toxins, and non-target plant material. Some quality systems set minimum and maximum content standards for desirable phytochemicals. Evaluation of the accuracy, precision and reproducibility of chemical measurements in natural products and biological specimens can be difficult. In 2002, the NIH Office of Dietary Supplements created a new program, the Analytical Methods and Reference Materials Program, to provide tools to address challenges inherent to analysis of natural products. The program is stakeholder driven, with participation by government agencies, non-governmental organizations, academic researchers, and the private sector. It provides tools for demonstrating the integrity of analytical data: 1) published methods that have undergone formal validation studies (useful for analysts just entering the field and for dispute resolution); 2) certified matrix reference materials for use as method development and method evaluation tools; 3) certified calibration standard solutions for use in compound identification and instrument calibration; 4) laboratory quality assurance programs to assist laboratories in evaluating and improving method, analyst, and laboratory performance. The poster describes the AMRM, provides an overview of accomplishments and resources made available by the program, and reviews suggestions for future program directions made by an external expert review panel charged with program evaluation.