Design Management Of The Design Phase Of The Antibody Drug Clean Workshop Based On Party A

Because of the strict control, high input and high cost of antibody drug, the design project of the pharmaceutical clean workshop has some special characteristics, which determines that only the pharmaceutical enterprises themselves to solve the problem. Also in recent years, there are frequent flaws in the GMP certification in China in clean workshop. pharmaceutical companies are only from the cleanroom design stage on the introduction of the necessary design management, in order to make the pharmaceutical enterprises through in the GMP certification and improve the antibody drug competitive. And the current pharmaceutical enterprises widespread design management awareness is not strong, lack of the cognition and the reference of pharmaceutical enterprises design management content; heavy light industry design, the lack of comprehensive analysis and overall consideration of factors which influence the cost of; lack of the design part of the decision-making, to pharmaceutical companies involved in the field put to the test.In this thesis, the problem of the design of the clean room of the antibody drug is set up, and the main research contents are finished, which are important references for the design and management of pharmaceutical enterprises.(1) Through the WBS decomposition method, the design and management of pharmaceutical enterprises in the design stage and design stage are decomposed, and the design of the clean plant is based on the content of the design management. In order to solve the problem of the design and management of Party A to provide support and design management content reference.(2) On the basis of Party A’s design and management, the most important part of the design and management of Party A, that is, the risk identification is carried out, which is also the problem of "lack of comprehensive analysis and the overall consideration" of Party A’s face. Through the rigid and flexible aspects, the factors of the cost of the clean room of the antibody drug are comprehensively identified, and then the cost of the key influencing factors is obtained.(3) On the basis of the design and management of Party A, the most important design management of Party A’s scheme design stage, namely, the design scheme decision-making, is studied. Through case analysis, using the method of value engineering, the design scheme is optimized, and the optimal scheme is obtained. In order to solve the problem of the design scheme of the Party A, provide theory and method basis and application reference.