Discussion On Application Of Risk Management In Management Of Small Volume Injection Production

The drug as a special commodity, its quality and patient’s life, along with the progress of the society, gradually improving the people’s living standards, understanding of drug quality risk has gradually improved, in this case, the primary task is to strengthen the pharmaceutical production enterprises to control all aspects of production, reduce the level of risk, to ensure drug quality.The small volume parenteral solutions of sterile preparations, belongs to the high risk of dosage form, the production process is complicated, the risk control points, the hardware, software, wetware have strict requirements, how to ensure safety, effective, stable, uniform and small capacity injection, to prevent phytotoxicity events occur, reduce the production process of various risks to the acceptable level, is one of the problems and challenges faced by sterile drug production enterprise, is a research topic of continuous improvement.This paper mainly uses some of the commonly used risk management tools for small volume injection workshop from the2010version of the GMP regulations reform design to the production process quality control of risk assessment, identification, analysis, evaluation of the risks in the production process, the unacceptable risk to take appropriate measures to control, to reduce risk, guarantee quality of products, the issue of the use of risk management tools have fishbone diagram method, failure mode effect analysis (FMEA) and the hazard analysis critical control point (HACCP), require the transformation of hardware factory, workshop equipment, air purification system, use the tool of risk assessment, Determine the reconstruction scheme, implementation, through the2010version of GMP certification.On the basis of our company through the2010version of the GMP certification of small volume injection workshop as an example, visible foreign matter generated to determine small volume injection production process is still continuing existence risk, the use of fish bone diagram to find out the causes of risks, analysis and study, find out the control measures are implemented, to minimize the risk of the visible foreign matter.With the application of2010version of the GMP in the reconstruction of the small volume injection workshop through risk management, so that our company small volume injection workshop smoothly through the national GMP certification of version2010, and then applied the risk management theory to find out the risk point of control in the production process through the GMP certification workshop, the visible foreign matter in the production process has been further control. In the small volume injection production process continuously using risk management concepts and tools to evaluate the risk of the production process, making the risk control measures, improve production efficiency, ensure product quality.