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MBA硕士论文_论通用电气药业公司改扩建项目质量管理与控制(64页)

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文本描述
摘要

众所周知制药工程项目具有实施周期长、难度大、情况复杂,而且较易受各类法规

影响的特性,造成这类项目在实施过程中面临投资风险、经济风险、技术风险等诸多风

险。由于在项目验收时又必须要通过由国家药监局组织的GMP(良好行为规范)认证,所

以该类项目又具有高标准质量的特殊性要求,因此同时又具有明显的质量风险。由于当

前新版GMP(2010版)的颁布使得质量管理在我国制药建设工程项目中逐步得到了大家

的重视。

但由于相比于其它发达国家我国医药工程建设标准的滞后和制药监管制度不完善,

再加上国内制药企业众多水平层次不齐的特点,在过去一段时间里出现了由于质量控制

不严发生了诸多药品不良事件。

2010年新版GMP突出阐明和确定了质量管理的理念与要求,明确要求质量控制管理

在厂房设施设计、建造阶段中的运用必须全面执行,质量控制是一个重要环节应当引起

广大业内人士重视。这就要求我们结合当前制药项目实际情况,从理论和实践寻找合适

的项目质量管理方法,以此提高我国制药项目质量水平。

本文以“通用电气药业公司改扩建项目质量管理与控制策略”为研究对象,从以下

方面进行阐述:一是对国内制药行业发展现状进行介绍,说明加强实施工程项目质量管

理的必要性和紧迫性;二通过介绍工程项目质量管理相关理论定义、特点及管理过程,

以及国内外质量管理理论研究及发展情况等来说明当前国内制药行业项目质量管理面

对的问题;三是通用电气药业公司改扩建项目特点背景介绍,阐述实施质量管理的必要

性和面临问题的提出;四是提出尝试建立通用电气药业公司改扩建项目质量管理系统

(包括质量体系、质量策划、质量管理控制等主要环节)的有效策略;五是对该项目所

涉及不同系统的质量控制方法进行说明;六是对笔者所提出质量管理路线及策略的总结

和阐述,同时说明这对于国内制药工程建设项目质量管理建立和开展具有一定的借鉴价

值和意义。

关键词:制药工程项目;新版GMP(2010版);项目质量管理体系和质量原则

第II页
华东理工大学硕士学位论文

The Study of Quality Control and Management for GE Healthcare

Shanghai Company Expansion Project

Abstract

The pharmaceutical construction project is apparently impacted by kinds of factors such

as investment, economy, and technology/rules due to long lead period, also with high

complexity and high quality requirement. These project needed be reviewed and approved by

SFDA with special high requirement on quality side when GMP (Good manufacturing

practice) auditing. Due to the new GMP (version2010) standard issued currently quality

management and control is more focused in pharmaceutical capital project and it took obvious

progress step by step. But because the original pharmaceutical construction standards about

quality is not perfect and supervising system is not strong enough, there are most of deferent

levels pharmacy factory in china and so some big bad accident happened in past years. So the

new GMP (version2010) defines and clarifies the concept and requirement for the quality

management. The quality control and management is important cycle applying in facility

design and construction phase. Related person should take more attention to this.

This file is subject to quality management study basing the case about the expansion

project of GE healthcare shanghai company,state briefly below points: The first is

introducing the quality development for the Pharmaceutical area in the world and it's

necessary to executer good quality for project execution. The second is stating the quality

definition and characters for this project to show what the changeling for this. The third is

remarking the problem of the case project met and how to execute the good quality control

and procedure by some case analysis. The fourth is raising the quality strategy proposal for

fitting this case project. The fifth is describing the quality method for deferent system. The

final is summary of the suggested method for the quality control and the future expectations.

Keywords: Pharmaceutical construction project; New GMP (Version2010); Project

Quality management system and Quality policy.