GMP的发展历程及其对制药行业的影响论文.doc

word格式精心整理版 范文范例 学习指导 GMP的发展历程及对制药行业的影响论文 专 业：12级生物工程专业 班 级：1班 姓 名：程子良 学 号：1231250002 短 号：680916 GMP的发展历程及对制药行业的影响论文 学生：程子良 指导老师：尹龙飞 摘要：“GMP”是英文Good Manufacturing Practice的缩写，中文的意思是“良好作业规范”或是“优良制造标准”，是一种特别注重在生产过程中实施对产品质量与卫生安全的自主性管理制度。GMP认证制度是国家对药品生产企业监督检验的一种手段，也是保证药品质量的一种科学、先进的治理方法。 我国引进和实施《药品生产质量管理规范》已有20多年历史，在这20年里不断改正、完善其内容，在我国推行实施制订了相应的法律法规，主要是与国际标准化接轨，是企业和产品增强竞争力的重要保证，是医药企业对人民用药安全高度负责精神的具体表现，是企业形象的重要象征。本文通过对GMP的定义的理解及发展进程系统的对药品GMP认证的现状进行综合分析，从而探讨我国制药企业实施GMP后的现状及GMP管理制度的意义。 关键词：GMP认证；制药行业；发展历程；影响  The paper of the development of GMP and the impact on the pharmaceutical industry. Undergraduate student: Cheng Zi liang Advisor: Yin Long Fei Abstrct：GMP is the abbreviation of English Good Manufacturing Practice, Chinese means Good work norm or Good Manufacturing standard, it is a kind of special attention in the process of production implementation on product quality and the hygiene and safety of autonomy management system. GMP certification system is not only akin dofme thods super visin gpharma ceutical enterprise sinour country，but also scientifican dadvance dmanagement togua ranteedrugs “quality”.During thece rtificating an dpracticing of GMP. Our introduction and implementation of the drug production quality management norms has a history of more than 20 years in the 20 years to correct and improve the content, promote implementation in our country to formulate the corresponding laws and regulations, primarily with international standardization, is the important guarantee of enterprise and product competitiveness, is the pharmaceutical companies for the manifestation of peoples medication safety and highly responsible spirit, is an important symbol of the corporate image. In this paper, through the understanding of the definition of GMP and the development process system of the comprehensive analysis of the status quo of drug GMP certification, which discuss the implementation of GMP pharmaceutical enterprises in our country after t