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Critical Chain Project Management For GMP Validation

Posted on:2005-03-23Degree:MasterType:Thesis
Country:ChinaCandidate:X ZhaoFull Text:PDF
GTID:2166360152997192Subject:Business Administration
Abstract/Summary:PDF Full Text Request
The GMP is the abbreviation of the good manufacturingpractices for pharmaceutical products. It's the quality guaranteesystem applying to pharmacy industry. The GMP validation is anintegral part of GMP. It's a series of activities with documentcertificate of bearing out any procedure, equipment, material,activity or system certainly leading to expected result. At present,although pharmacy industry rule of our country has made provisionsin written that GMP validation should be carried out according to theacquirement of project management , the GMP validation projectmanagement is still in beginning even vacant stage. The concept ofGMP validation project management has not been formed. Thereport on it also hasn't appeared in documents. Although HXpharmacy Limited company has carried out project management toGMP validation of injection with small capacity according to ruleacquirement, many statements lead to serious putting off ofvalidation management like resource conflicts, scope changing,improper estimation to limited project time, too tough in plan, out ofcontrol in process and so on. Under the prediction of consideringhuman's psychology function, the text has analyzed carefully thereason of management project delaying from Student syndrome,...
Keywords/Search Tags:GMP validation, Project management, TOC, Risk management
PDF Full Text Request
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