| Risk management is a scientific method aimed at preventing and controlling risk factors,and has been applied effectively in many fields.All countries in the world are combining their own situation,committed to continuously explore the law of drug management,so as to establish a more perfect and more effective management system to protect product quality.The implementation of drug risk management,the first to have a certain understanding of it;secondly,to meet its own unique situation,develop a more reasonable management system,which affect the quality of the drug by minimizing the risk.First of all,according to the State Food and Drug Administration statistics,according to the 1998 revision of the drug GMP certification,certification scope of freeze-dried powder enterprises a total of 1468 households,according to the 2010 Revision of the drug GMP certification,certification within the scope of the freeze dried powder enterprises have 480 households.With the implementation of the new GMP certification,the demand for freeze-dried powder needles is more stringent,enterprises are not easy to reach standards,through GMP.In these 480 enterprises,Jilin has only 7 enterprises through the new version of GMP certification,while Yanbian has only one.This paper introduces the unique characteristics of freeze-dried powder injection.As a new dosage form,the product has good stability and can be preserved for a long time.After adding the corresponding solvent,it can dissolve quickly and recover the characteristics of the drug.However,the use of problematic freeze-dried powder products may result in problems such as thrombosis,which can directly affect the health of human beings.Therefore,in order to avoid visible foreign products,will be applied to the risk management of freeze-dried powder production process,reduce the failure mode in the production process of the level of risk to an acceptable level,so as to produce safe and effective,stable and uniform products.Therefore,the application of scientific methods and techniques of quality risk management to prevent,control,reduce or eliminate risks has become an important problem faced by the manufacturers of freeze-dried powder injection.Secondly,this paper introduces the theory of risk management in detail.Starting from the process of risk management,from risk assessment to risk control,and then to risk communication are outlined.In the risk management tool,failure mode effect analysis(FMEA)method by calculating the risk priority number analysis can be qualitative or quantitative,more intuitive to see the change of the level of risk,so the risk management of the use of FMEA tools.Finally,the specific application of FMEA method in the production process of A X freeze-dried powder injection,analysis of freeze-dried powder in the production process of water injection system,air conditioning system,flow and logistics,vial cleaning and sterilization,the rubber plug and the aluminum cover processing,liquid preparation,filling,freeze-drying,capping,labeling and packaging sectors.The potential failure mode of the risk assessment in the existing control measures,the use of measures to control the risks unacceptable.Using FMEA method and risk point of high risk level of freeze-dried powder production water injection system,air conditioning system,in the process of production logistics,compounding,washing,cleaning,plug filling,freeze drying,light inspection,packaging and other sectors are the risk control after the implementation of the re evaluation,RPN data show that of these,effective measures to reduce the risk to an acceptable level,so as to achieve the purpose of ensuring product quality.Freeze dried powder injection of sterile preparations belongs to non final sterilization,must take effective measures to control the pollution of dust particles,microorganisms and bacterial endotoxin drugs and other risks,to minimize the risk of contamination of the products,to ensure the production of medicines in accordance with the intended use. |
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