The Difference and Connections between Management Review and Self-inspection of Vaccine Manufacturers
Objective:To achieve the purpose of improving the quality management level by identifying and exploring the differences and connections between management review and self-inspection in the quality management of vaccine manufacturers,and guide manufacturers to effectively implement management review and self-inspection in production and operation process.Methods:Compared with ISO 9001 and Good Manufacturing Practice(revised in 2010),the gap analysis method was used to analyze the differences and connections between management review and self-inspection of vaccine manufacturers.Results:There were differences between the management review and self-inspection of vaccine manufacturers in terms of audit subjects,audit elements and basis,organization and implementation personnel,report content and output content,but at the same time,both were important aspects of manufacturers quality management,which should be promoted and complemented each other.Conclusion:Management review and self-inspection are important measures for manufacturers self-supervision or self-improvement.By effectively combining the two in management activities,manufacturers can enhance the level of quality management in a multi-level and in all aspects.
vaccinemanagement reviewself-inspectionquality management systemsystem construction
NETL
NSTL
万方数据
