Risk Management In Biological Vaccine Production Process

This thesis is about risk management in the process of biological vaccine production. Biological vaccine is to obtain microorganisms, cells and the organization of all kinds of animals and anthropogenic and liquid preparation of biological materials from normal used or to genetic engineering, cell engineering, protein engineering, fermentation engineering and biotechnology, which is use for medicine for prevention, treatment and diagnosis of human disease. However, there are many uncertainty factors in the process of biological vaccine production, which will lead to poor quality of biological vaccine production. There is not only waste the enterprise production time and cost, but also harm to the health the person in vaccination caused Therefore, research of risk management in the process of biological vaccine production is great significance process for enterprises production.This thesis is focused on the risk management in the process of biological vaccine production from three aspects, risk identification, risk evaluation and risk control.Firstly, the production process will be mainly divided into the preparation, fermentation, purification, preparation and verification in combination with the characteristics and production technology of biological vaccine production. According to experts’consultation and research and the methods of brainstorming method, Delphi method, the tree of risk in biological vaccine production will build to indenfity five categories, the person, material, environment, technology and equipment. These risks can subdivide into 59 kinds of risk and deeply analyze all of them.Secondly,59 kind of risk is assigned one by one from three dimensions ("severity""number offrequency", "testing") and experts’investigation. In addition, the consequences result will be analyzed from FMEA method (Failure Mode and Effective Analysis). Risk factor will divided into four levels in accordance with the size of the risk priority number, which is easy for further anylysis relating important degreein the process of biological vaccine production.Finally, risk control measures in the process of biological vaccine production will be formulated on the basis of risk analysis and risk evaluation; Depending on different risk factors, risk avoidance, risk transfer and risk mitigation will be respectively adopted, which can be used to formulate quality risk management policy("comprehensive evaluation system, to reduce the quality risk, ensure the safety of medicines, and reflect the enterprise value") and anylze the each risk.