Quality Assurance versus Quality Control in Herbal Manufacture

Quality assurance and quality control are related but conceptually distinct functions within herbal drug manufacture. Quality assurance encompasses the entire systematic framework of policies, procedures, and organisational culture designed to ensure that a herbal product will consistently meet its required specifications, spanning supplier qualification, Good Agricultural and Collection Practice compliance at the raw material stage, Good Manufacturing Practice compliance during processing, and comprehensive documentation and traceability throughout the supply chain. Quality control, by contrast, refers specifically to the analytical testing activities — pharmacognostic evaluation, chromatographic standardisation, microbial testing, and contaminant analysis — performed on raw materials, in-process samples, and finished products to verify that they meet their predefined specifications before release. Quality assurance is therefore the broader, preventive, system-level function, while quality control is the narrower, detective, testing-based function that generates the specific data quality assurance relies upon to certify product release.