制药工程项目中的验证进度管理探讨
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摘要
在制药工程项目中,重技术轻管理而导致企业在项目后期的验证管理中重复投入大量资源和时间,造成一定浪费的现象时有发生,未充分识别验证进度风险因素以及缺乏有效的进度控制方法是主要原因。从项目管理的角度,从风险评估和进度控制两个方面进行探讨,尝试探索适用于制药工程项目验证进度管理的有效方法,以最大限度降低验证管理投入的资源和工时,提高管理效率。
In pharmaceutical engineering projects, in view of emphasis of technology and ignorance of management, large amount of resources and times will be put into later validation and management, and it was not recognized that the causes of resource and time wastes were incognizance of risk in validating progress and lack of effective method for controlling progress. In this article,from the view point of project management, and with the aspects of risk evaluation and progress control, it was try to explore the applicable method in the management of validating progress for pharmaceutical engineering project so that to enhance the efficiency of management with the minimum resources and times in validating progress.
In pharmaceutical engineering projects, in view of emphasis of technology and ignorance of management, large amount of resources and times will be put into later validation and management, and it was not recognized that the causes of resource and time wastes were incognizance of risk in validating progress and lack of effective method for controlling progress. In this article,from the view point of project management, and with the aspects of risk evaluation and progress control, it was try to explore the applicable method in the management of validating progress for pharmaceutical engineering project so that to enhance the efficiency of management with the minimum resources and times in validating progress.
引文
[1]国家食品药品监督管理总局.药品生产质量管理规范(2010年修订)[S].
[2]GB/T 50326-2006,建设工程项目管理规范[S].
[3]国家食品药品监督管理总局.药品生产质量管理规范(2010年修订)附录:确认与验证[S].
[4]ISPE Baseline Pharmaceutical Engineering Guides for New and Renovated Facilities:Volume 5 Commissioning and Qualification[S].2001.
[5]ICH Harmonized Tripartite Guideline,Quality Risk Management:Q9[S].2005.
[6]王勇.医药工程C&Q项目物料和仪器管理浅析[J].化工与医药工程,2017,38(2):29-32.
[2]GB/T 50326-2006,建设工程项目管理规范[S].
[3]国家食品药品监督管理总局.药品生产质量管理规范(2010年修订)附录:确认与验证[S].
[4]ISPE Baseline Pharmaceutical Engineering Guides for New and Renovated Facilities:Volume 5 Commissioning and Qualification[S].2001.
[5]ICH Harmonized Tripartite Guideline,Quality Risk Management:Q9[S].2005.
[6]王勇.医药工程C&Q项目物料和仪器管理浅析[J].化工与医药工程,2017,38(2):29-32.