The Risk Management And Control Of The Injection

Injection as a dosage form that is injected into the body directly, the safety requirements of injection is higher than other dosage forms. Several typical safety events about injections occurred during recent years because some enterprises lack of risk awareness of quality, the fact shows that it is necessary to conduct the risk management.The risk management of medicine quality is still at the primary stage in China, still lack of guidance documents and scientific method. Taking small volume injections for example in this text, according to the safety events occurred and quality problems in quality announcement, take material and supplier management, foreign matter and sterility control as the object for risk management, establish risk control measures about production process.1Methods and Results1.1Risk control of material and supplierBased on the definition of membrane Filters for bacterial retention. Established reference for in-house standard of materials Microbial Limits and established related calculation method, also established a risk assessment model of material supplier based on process capability, quantify the quality risk of supplier by the data collection, calculation of critical quality attributes and risk coefficient, easy to control and take action.1.2Risk control of visible particleBy analyzing the type of visible particle in injections, glass debris is studied in this text which has maximum ratio in the visible particle. Analyze the risk factors in terms of glass materials, glass and drug compatibility, ampoule processing, equipment, check methods, and develop control measures for each factor.1.3The Quality Risk Control of sterilitySterility assurance level of the injection is studied in this text, analyzing the personnel impact on the environment, environmental factors that can purify the personnel impact and the risk of equipment changing specifications, according to the propagation characteristics of microbe in materials, the liquid should control the time after degerming to sterilization to reduce the risk, it is effective to adopt the method of controlling heat-resisting bacterium in the process of non-final sterilization process on the flow of steam sterilization, the sterile risk of injection can be reduced through the above measures.2The significance of this study(1) Provides a theoretical foundation and scientific basis for enterprises to establish in-house standards of the materials, it’s helpful to establish a correct and reasonable quality standards from the perspective of risk. Establish a mathematical model for assessment of suppliers which is more scientific and accurate to assess the risk of suppliers, provides a theoretical basis for the selection of suppliers.(2) Find out the root cause about unqualified visible particle and provides a method and guide for selection of packaging materials of injections, it is helpful to solve the visible particle fundamentally. Meanwhile, proposed the use of advanced light inspection equipment to reduce the missing rate of visible particle, and reduce the quality risk.(3)Analyze influence factors of injection sterility from some unique angle, and proposed problem which are easily to ignore but have big risk and control measures. It’s helpful to improve assurance level of injection sterility.