The Research On The Quality Risk Managemengt Of Thevaccine Share-line Production In S Company

The bio-pharmaceutical industry has developed rapidly with the rapid development of our country's economy.At the same time,relevant regulations of the state are constantly being improved.The quality risk management is an important part in the introduction of new Good ManufacturingPractice.It's been widely used throughout the life cycle of drugs.Vaccine manufacturing is a crucial component of bio-pharmaceutical industry.In down-stream production of vaccine manufacturing,share-line production is usually used,but the risk assessment and control for share-line production is imperfect.To solve this problem,the author carried out a preliminary research on the quality risk management of share-line production and obtained the following results.(1)By researching on published papers,laws and regulations on vaccines in China and abroad as well as risk management in China and abroad are studied.Through the study,the feasibility evaluationassessment form,equipment suitability assessment form,failure mode and effect analysis(FMEA)and failure mode effects and criticality analysis(FMECA)of vaccine share-line productions are designed,and the quality risk management procedure for share-line production is established.(2)Apply the established risk management procedure to vaccine manufacturing company S.By using the feasibility and suitabilityassessment form to evaluate the products manufactured by company S,four vaccine products can share production line at final bulk preparation,final product filling and packaging stage.The share-line risk level dropped significantly by using risk assessment and control tools.(3)The share-line risk assessment index is established by social economic statistics theory.It is used for the evaluation of process application effect.There is a significant difference in risk control after the quality risk management process is used,because the chi-square testresult is p < 0.5.The chi-square test's data is form the establishment of the share-line risk assessment index.Comparing fixed asset investment of share-line production with single-line production,single-line production needs investment of 67.8261 million and share lie production needs investment of 91.7997 million.There are four share-line products in company S,the share-line productioncan reduce investment in fixed assets by 179.5047 million.The share-line production can reduce fixed asset investment effectively.The production quality risk management process of vaccine share-lineestablished in this thesis can systematically analyze the feasibility and the applicability of share-line of the vaccine,reduce the share-line risk level significantly,help enterprises make decisions,reduce the investment in fixed assetsand reduce the product cost.This process can provide reference for other vaccine enterprises or biopharmaceutical enterprises that have share-line productionand improve the quality risk management system of enterprises.