Roadmap for Quality by Design Implementation for Dietary Supplements

Area of Science:

• Dietary Supplements and Nutraceuticals
• Quality by Design (QbD) Principles
• Botanical Raw Material Characterization

Background:

• Growing adoption of Quality by Design (QbD) in the dietary supplements industry.
• QbD implementation faces challenges due to botanical raw material variability and defining critical quality attributes (CQAs).

Purpose of the Study:

• To address challenges in QbD implementation for herbal drugs and dietary supplements.
• To provide an overview of techniques for identifying and characterizing botanical raw materials.

Main Methods:

• Review of various techniques for botanical raw material identification.
• Review of methods for characterization of botanical raw materials.
• Analysis of the relationship between manufacturing processes, CQAs, and raw material variability.

Main Results:

• Identified numerous techniques applicable to botanical raw material analysis.
• These techniques support the successful implementation of QbD for botanicals and dietary supplements.
• Understanding CQA relationships with supplement properties and manufacturing is crucial.

Conclusions:

• Effective QbD implementation requires addressing botanical quality variations and CQA definition.
• Collaboration between academia, industry, and regulatory bodies is essential for integrating QbD into current regulations.
• Further research and discussion are needed to refine QbD strategies for dietary supplements.