Objective To study how to ensure the quality of listed drugs by using quality risk management to control the risks in the drug collinear production because some pharmaceutical companies produce drugs with multiple dos...Objective To study how to ensure the quality of listed drugs by using quality risk management to control the risks in the drug collinear production because some pharmaceutical companies produce drugs with multiple dosage forms and specifications on the same line to save costs in China.Methods The application status of quality risk management in the production of drugs was analyzed by consulting literature,field investigation and research re-lated policies.Results and Conclusion When introducing co-line products,we should focus on combining prod-uct reality,establish a cross-professional team in comprehensive quality,R&D,equipment,and production.Then we can coordinate quality risk management to integrate with each other to avoid“shortcomings”in different links,which will affect the effectiveness of risk management.When a company conducts co-line production,it should rely on quality risk management theories to establish a scientific quality management system,reasonably use qual-ity risk assessment tools to evaluate the types of co-line production,and control key risk factors effectively.These methods can ensure the risk of co-production within an acceptable range.展开更多
文摘Objective To study how to ensure the quality of listed drugs by using quality risk management to control the risks in the drug collinear production because some pharmaceutical companies produce drugs with multiple dosage forms and specifications on the same line to save costs in China.Methods The application status of quality risk management in the production of drugs was analyzed by consulting literature,field investigation and research re-lated policies.Results and Conclusion When introducing co-line products,we should focus on combining prod-uct reality,establish a cross-professional team in comprehensive quality,R&D,equipment,and production.Then we can coordinate quality risk management to integrate with each other to avoid“shortcomings”in different links,which will affect the effectiveness of risk management.When a company conducts co-line production,it should rely on quality risk management theories to establish a scientific quality management system,reasonably use qual-ity risk assessment tools to evaluate the types of co-line production,and control key risk factors effectively.These methods can ensure the risk of co-production within an acceptable range.
