Design And Application Of GMP Compliant MES For Health Food And Drug Factory

Based on the study of technological process of health food and drug production, GMP,MES theories and other relevant concepts, this thesis analyzes the health food and drugproduction compliance with GMP, the common requirement of manufacturing executionsystem, and common MES characteristics under the influence of GMP.On this basis, this thesis firstly establishes a common business model applicable to thewhole health food and drug industry and in compliance with GMP because it is the basis of amanufacturing execution system in compliance with GMP. The business model of apharmaceutical factory completes the MES virtual framework, including physical model,process model, and execution model. In detail, physical model, fundamental information ofthe factory information model, represents the physical parts of a factory, including factory,production line, organization and resources, etc. Process model represents the control parts ofan information model, including the container level, operation, specification, product family,product, recipe and technical process, etc. Execution model, which is based on physical modeland process model, includes all aspects of an information model during the productionactivity, such as tracing the product and resource status and history on the manufacturing field,and making all production activities visualized in real time.Secondly, this thesis also analyzes how to supervise drug production according to GMPby means of bar code information and relevant regulations. Since most unqualified productscan be traced back according to key production data, quality data, and input and outputinformation during the production process, a comprehensive manufacturing processsupervision in compliance with GMP can be realized by recording relevant information ofraw materials, goods in process, end-products, packaging, in the manufacturing executionsystem, and labeling all the information with time, place, person-in-charge, and other relevantdetails. On this basis, making use of the bar code and association rule, further query andtrace-back can be realized by certain software system. At last, a comprehensivemanufacturing process supervision in compliance with GMP can be realized. Based on an analysis and model establishment of the production management process,this thesis integrates the technical process with GMP, makes a normative analysis andconclusion on the production management process, and finally extracts the functionalmodules within the manufacturing execution system that are suitable for secondarydevelopment and reuse in the health food and drug enterprises, so that they can establish acorresponding manufacturing execution system rapidly.By the application detail, a conclusion can be drawn that in order to apply MESsuccessfully and make it a powerful tool in production management, the appropriate hardwareand an experienced development team must be selected.Generally speaking, this project is oriented to deal with relevant problems andrequirements on production process management and real-time workshop supervision, andintegrates the advanced corporate information management concepts with managementstandard like GMP. This thesis focuses on studying the integrated framework and functionframework of a MES that is in conformity with GMP, and finally designs an appropriate one.This MES realizes several production management functions including production operationcontrol, batch recording management, equipment and environment monitoring,bar-code-based material batch tracing and trace-back, etc.The result of this study is going to satisfy the production management demand in thehealth food and drug enterprises with quality management as the core. The result can alsohelp enterprises in realizing a normalized, standard, and information-based production processmanagement, and furthermore promote the development of information technology in thefield of health food and drug products in our country.