Roadmap for Quality by Design Implementation for Dietary Supplements

Abstract

Abstract Background: Recently, there is a growing interest in quality by design (QbD) in the dietary supplements industry. Objective: Effective QbD implementation necessitates a comprehensive understanding of multiple factors such as; the relationship between the critical qualities attributes (CQAs) and the scientific properties of the dietary supplement, the relationship between the manufacturing process, CQAs and the variability in raw materials. There are still two critical challenging concerns to be addressed in the implementation of QbD for herbal drugs. First, the quality variation of botanical raw materials and second, the difficulty in defining the satisfactory ranges of CQAs. Method: In order to tackle these challenges, this review provides a snapshot of the numerous techniques that can be used in the identification and characterization of the botanical raw materials, therefore, will help in the successful QbD implementation for botanicals and dietary supplements. Conclusions: In order to implement this approach and to be considered in the current dietary supplement regulations, fruitful discussions and collaborations between academia, industry and regulatory agencies are required.