Project Quality Management For Code Assignment System Installation Of Drug Traceability Code In Pharmaceutical Company

Pharmaceutical enterprises as drug traceability system,the main body responsible for the assignment of how scientific and rational management code system installation,is a need to study for the pharmaceutical enterprise project management issues.Based on the actual case of assigned a code system for the installation,in view of the quality management code assignment system installation,conducted a preliminary study.In this paper,firstly systematically introduces the characteristics of the project and operation process,ways of working and the specific requirements of the stakeholders.On this basis,with the requirement of GMP basic demand,with PDCA cycle mode in the project life cycle management are studied,in Planning phase,on the basis of quality validation of V model,prepared Validation Master Plan(VMP)as validation work guideline,set up the framework,including all the validation plan of the entire project,organization,project plan,process,the next step of work has been clear about the work.In Phase D,implementation stage,set quality control process,combined with the GMP requirements and user needs,using a variety of ways to ensure execution of the project,such as visual management to strengthen the team members' participation and the sense of responsibility,using PDCA cycle to solve problems,to use 5 w or fishbone diagram to discover the root reasons of the problem.Using tools and techniques of quality management planning,design quality management plan of production,namely through code assignment system design qualification(DQ),installation qualification(IQ),operational qualification(OQ)for quality control.In Phase C,through the performance qualification(PQ)and production validation(PV),deviation management,quality control methods,such as,to examine the system installation project,but ensure the quality of project execution to meet the needs of practical production,finally complete the validation report and summary report.Base on the project quality management study of code assignment system installation,utilizing the theories of project management,exploration and study,according to the pharmaceutical enterprise's characteristic,summarized a set of simple and feasible way for the pharmaceutical enterprises of project quality management,avoid mistakes and reduce the loss caused.