Quality Risk Management in Traditional Chinese Medicine Preparations: A Comprehensive Analysis of Hazards, Control Points, and Effectiveness

• QRM significantly improves the quality and safety of TCM preparations by systematically identifying and controlling hazards. • Critical control points in the production process are essential for mitigating risks such as contamination and adulteration. • Integration of QRM with traditional quality control methods enhances regulatory compliance and patient safety. • The study provides a framework for implementing QRM in TCM manufacturing, applicable to both small and large-scale producers.