Orthogonal validation of analytical and quality systems for botanical products

The widespread human use of botanical products for health benefits depends on a solid scientific foundation to document their safety, efficacy, chemical composition and manufacturing control. US FDA current good manufacturing practices (cGMP) for dietary supplements require established specifications and testing methods to ensure identity, purity, strength and consistency of supplement ingredients, including botanicals. As complex mixtures prone to natural variation due to climate, location of origin, and harvest methods, botanicals present unique challenges for traditional quality assurance systems. Further, validation of reference standards, methods and processes for botanical quality assurance are essential to conformance to GMPs. Using ICH, ISO and Total Quality Management principles, an orthogonal framework was established to address the quality issues often associated with commercial botanical extracts. This framework is essential to understanding the critical factors affecting botanical product quality, and provides valuable insights into the analytical methods and standards required to document and improve botanical product quality.