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依据工程项目生命周期,详细分析了标准确定、采购建造、竣工验收3大阶段,根据各阶段的特点建立不同的质量管理体系,并采用风险管理的方法对工艺进行了分析和评估,对后续产生的设计结果进行了系统管理,为所有硬件系统符合新版GMP和顺利实现工艺技术转移提供了有力保障。
According to the project life cycle, the paper analyzes in detail three stages of standard determination, procurement construction and completion acceptance, establishes different quality management systems according to the characteristics of each stage, and analyzes and evaluates the process by adopting risk management methods. The design results of the system management, all hardware systems meet the new GMP and the smooth realization of technology transfer provides a strong guarantee.