Application Of Risk Management In Chinese Traditional Medicinal (TCM) Injection Production

Due to a special commodity, drug’s quality is more closely related to patient’s life. Along with the development of economy and the improvement of living standards, people pay more attention to the drug quality. Up to date, the major tasks faced by drug manufacturers are to strengthen the process control of drug production,reduce the level of risk, and ensure the quality of drugs.As adverse events caused by Chinese traditional medicinal (TCM) injections happened frequently in recent years, the safety of TCM injection has gained high attention from supervision department and public. Pharmaceutical companies have been facing fatal challenges, and it is imperative to improve the safety and quality controllability of TCM injection. The State Food and Drug Administration (SFDA) has been reassessing the safety of TCM injection since 2010, which require pharmaceutical companies to study risk assessment and control of TCM injection on each stage from industry to pharmaceutical use. Good Manufacturing Practice (GMP) implemented on March 1st 2011 has proposed clear requirements for pharmaceutical company to manage risk. However, Chinese pharmaceutical companies are still in preliminary stage of risk management and need long time to establish the system to manage the risk in production and quality control.As high risk pharmaceuticals, TCM injections have complex components, complicated production processes, many risk control points, and strict requirements regarding hardware, software and wetware. Currently, using scientific methodology and technique of risk management to prevent, reduce, control, or spread risks is an important subject for pharmaceutical companies manufacturing TCM injections. How to make TCM injections safe, effective, stable, and uniform, to prevent drug misadventures, and to reduce risks in the process of production to an acceptable level are the issues and challenges for pharmaceutical companies manufacturing TCM injections. Therefore, it is a critical issue for pharmaceutical companies manufacturing TCM injections to improve quality and safety by risk management.In this paper, we elucidated the features of TCM injection, the domestic and international situation and problems of risk management, and the necessity and urgency to conduct risk management.Common risk management tools includes hazard analysis critical control point (HACCP), failure mode and effect analysis (FMEA), failure mode, effects and criticality analysis (FMECA). We used these risk management tools to conduct risk assessment of the production quality control of TCM injection X from company A, then identified, analyzed and evaluated the risks in the process of production, took appropriate measures to control unacceptable risk, and in the end ensured the quality of product.