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Provincial Food and Drug Administration "black box" special team to Pukang biological research service information construction and "black box" upgrade work

Release time: 2022-03-24

On March 23, the "black box" special team of the Provincial Food and Drug Administration went to Zhejiang Pukang Biotechnology Co., Ltd. to investigate the service information construction and the iterative upgrade of the "black box" application。The person in charge of the drug production department and service center of the Provincial Drug Administration, the person in charge of the drug production department of the Hangzhou Municipal Bureau and the relevant personnel of the special class participated in the research service。



Zhejiang Pukang Biotechnology Co., Ltd. is a vaccine manufacturer, mainly producing lyophilized live attenuated hepatitis A vaccine。The research team listened to the construction of Pukang WMS, MES, LIMIS and other information systems, and the application upgrade of "black box" 2.01 version and data through the work, to understand the main difficulties in the process of information construction of Pukang, the relevant problems were discussed and answered on site。 

The person in charge of the "black box" special class put forward the requirements for the information construction of Pukang in the next stage and clarified the time node。First, it is necessary to speed up the confirmation and verification progress of the MES system and LIMIS system to ensure that the electronic production records and inspection records are fully realized before July 1。Second, it is necessary to accelerate the upgrade of the "black box" application system and data import, and ensure that the system upgrade and data interconnection are basically completed before April 3。Third, the service center should strengthen guidance and services, and timely solve the problems and difficulties encountered in the upgrade of the enterprise system。