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In this cooperation project, Gates foundation will fund China National Biotec Group in alternative ways to support building of new manufacture facilities for OPV. After building and WHO pre-qualification of the new campus, it is competent for interna...
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Chengdu Institute of Biological Products Co.,Ltd. Officially Submitted Application Documents to WHO for JE Vaccine Prequalification
After 4 years hard working and effort, on Jan 18th,2012, the subsidiary of China National Biotec Goup Co.,Ltd.(CNBG)Chengdu Institute of Biological Products Co.,Ltd.(CDIBP) officially submitted product summary files (PSF) and packaging samples to WHO for prequalification application of live Japanese encephalitis vaccine. This indicates the JE project has accomplished a critical milestone mission and initiates prequalification examination in the year of 2012.
In the past more than 4 years, according to ISO guideline and WHO GMP requirements, CDIBP reconstructed quality management system and updated more than 10 thousand SOP and documentation, built new JE vaccine facilities and renovated related equipment, finished the construction of 5 new facilities and their renovation, verification and validation. CDIBP has also finished training of more than 300 thousand people, achieved dramatic improvement on quality management, accomplished the goal of matching international standard and the quality of personnel has been comprehensively enhanced.
With their unchanged work enthusiasm, CDIBP will continuously improve its quality management system, get ready for WHO on site GMP examination and work hard to let JE vaccine become the first WHO prequalified vaccine in China.