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- W2383884201 abstract "OBJECTIVE:To provide reference for the improvement of Good Manufacturing Practice(GMP)document management of pharmaceutical enterprises. METHODS:Introducing GMP document lifecycle management model,according to research and practice of the model,the problems about GMP document lifecycle management of the enterprises were analyzed to propose appropriate measures. RESULTS:The problems about GMP document of pharmaceutical enterprises included absence of systematic, integrate,operable and scalable drafting,formalized documentation review,unsatisfactory staff training,inadequate operation and unsuitable disposal,etc. According to GMP document lifecycle management model,it was suggested to design the GMP documents on the top level;define the responsibilities and reinforce the documents approval;strengthen training and management and improve the effects of training;improve the mechanism of rewards and punishments,and enforce the implementation of documents;store documents scientifically and carry out document changes control. CONCLUSIONS:It has very important function to enhance the quality of enterprise management level and promote the effective implementation of new GMP by establishing a systematic,scientific and practical document management system and implementing the GMP document lifecycle management effectively." @default.
- W2383884201 created "2016-06-24" @default.
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- W2383884201 date "2014-01-01" @default.
- W2383884201 modified "2023-09-26" @default.
- W2383884201 title "Survey on the GMP Document Lifecycle Management of Pharmaceutical Enterprises" @default.
- W2383884201 hasPublicationYear "2014" @default.
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