Study On Risk Assessment And Control Of Z Cephalosporin Powder Injection Product Line Production

With the continuous improvement and intensification of relevant laws and policies in the pharmaceutical industry,especially the adjustment of GMP on-site inspection from regular to flying inspection mode,the pressure on the production and operation of pharmaceutical enterprises is increasing year by year.It is in this context that pharmaceutical enterprises,especially high-risk cephalosporin injection enterprises,actively improve their quality management system,especially the introduction and application of quality risk management.This paper studies the risk assessment of co-production at home and abroad by searching literature.According to the actual situation of co-production of cephalosporin injection products in Z enterprise,a group of people who can complete a professional work,task or have some special skills in the organization can show high performance,called SME(Subject Mattered Expert)team,using quality risk management tools.Firstly,the feasibility of collinear production and the applicability of facilities and equipment in collinear production workshop are evaluated.Then,the hazards of multi-product collinear production are identified and effective control measures are put forward.The following research results are obtained.(1)In view of the possible interaction between multi-product collinearity,SME team members were organized to brainstorm the risk identification of equipment and facilities,plant design,production management,personnel operation,material management,production process quality control and other aspects,and finally confirmed that collinearity production mainly exists the following hazards: Cross contamination,confusion and human error.(2)To evaluate the risk of co-production,FMEA method is used to evaluate the risk,and the appropriate acceptable risk limits are selected according to the SME team's recommendations.The severity S,probability P and detectability D are multiplied together to calculate the RPN risk priority.RPN = S *P *D,RPN is an important indicator of FMEA,determines the priority of risk,the greater the value,the higher the risk,to take priority risk control measures.(3)Propose control measures for identified risks and conduct a second assessment until the risk is reduced to an acceptable level.Finally,ensure the quality of products produced on the same line and enhance the medication safety of patients.