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[Risk control system construction of Shenfu injection]
Da-Li Tian1, Ke Li, Jun-Jie Jiang
1Ya'an SanJiu Pharmaceutical Co., Ltd., Ya'an 625000, China. tiandali@ya999.com
Summary
A risk-control system for Shenfu injection was established to ensure stable quality and minimize potential damage. Future efforts will focus on strategy, organizational structure, and interdepartmental collaboration for traditional Chinese medicine injections.
Area of Science:
- Pharmacovigilance and Quality Management in Traditional Chinese Medicine (TCM) Products.
Context:
- Shenfu injection, a key TCM product, requires robust quality control measures.
- Potential risks exist across its lifecycle, from production to clinical application.
Purpose:
- To establish a comprehensive risk-control system for Shenfu injection.
- To ensure the stable quality and safety of Shenfu injection.
- To mitigate risks associated with TCM injection production and use.
Summary:
- A systematic risk assessment was conducted across various stages including production, Good Agricultural Practices (GAP), research and development, circulation, clinical application, intellectual property, and emergency treatment.
- A preliminary risk-control system for Shenfu injection has been developed.
- The study identified key areas for ongoing risk management.
Impact:
- The developed system provides a foundational framework for risk management in Shenfu injection.
- This initiative holds significant implications for establishing similar risk-control systems for other traditional Chinese medicine injections.
- Recommendations for future risk control include strategic planning, organizational refinement, and enhanced interdepartmental collaboration.
