Development and Validation of Analytical Methods for Assessing Chemical and Biochemical Quality in Globally Marketed Consumer Products: Implications for Marketing and Regulatory Policy

Abstract

Globalisation of markets for consumer products has enhanced the requirement for reliable analytical methods for assessing the chemical and biochemical quality of a wide range of product types, such as foods, herbal products, pharmaceuticals, cosmetics and new products utilising nanotechnology. The study looks at the development and validation of analytical methods for identification, quantification, monitoring of product constituents, contaminants, adulterants, degradation products and biological markers. It emphasizes on the most important validation parameters such as accuracy, precision, specificity, sensitivity, linearity, detection limit, quantification limit, robustness and reproducibility. The study also examines the use of chromatographic, spectroscopic, molecular, instrumental and sensor-based methods for the production of reliable quality evidence. In addition to their laboratory performance, the study examines the impact of analytical results on product labeling, quality claims, consumer confidence, market access and regulatory decision making in world markets. The importance of harmonised validation practices, laboratory quality assurance, analytical traceability and transparent communication of information about product quality is given special consideration. The study suggests a new paradigm, in which scientific evidence is validated and used for both consumer protection and responsible marketing. Enhanced analytical method validation can further increase the analytical comparability from one market to another, support regulatory submissions as well as minimize the risk of adulterated or contaminated product and allow for a more robust quality assurance basis for marketing claims.