GMP在药品包装行业中的应用

文档编号:BZ013  文档字数:23085.页数:35

摘  要
  GMP是人类科技进步和管理学发展的必然产物，它是适应保证药品生产质量管理需要而产生的，在国际上已成为药品生产和质量管理的基本准则。药品包装是药品生产的继续，是对药品施加的最后一道工序，随着药品GMP管理的深入，我国食品和药品监督管理局颁布了一系列法规，其中将药包材作为药品生产的辅料也纳入了管理的范畴，本文通过企业案例调研分析，深入认识目前GMP在药包材企业的实施应用状况，指出企业实施GMP规范后存在的不足，随着时间的推移，在对药品包装生产企业实施严格的GMP认证是迟早的事。本文所述包装是指直接接触药品的包装材料和容器，简称药包材。
 
关键词：GMP  药品包装 质量管理   药包材 

Abstract
 GMP is the certainty product after the development of the human science＆technology and management, which is to meet the needs of pharmaceutical production and quality management, and it has become the basic criteria in the world. Pharmaceutical packaging is a final step which is to follow the production of drugs. With the management of GMP going deep into medicine, China’s Food and Drug Administration issued a series of laws and regulations which include the YBB as the materials in pharmaceutical production. Through business case study analysis, in-depth understanding of the current GMP  packaging materials of the medicine enterprises in the implementation of the situation, pointing out that the implementation of GMP standard business after the deficiencies.With the passage of time, to ask the pharmaceutical enterprises to implement GMP certification strictly will happen sooner or later. In this paper, the packaging refers to the packaging materials and containers which touch the drug directly. The abbreviation is the packaging materials of the medicine.
 
Key words: GMP   pharmaceutical packaging     quality management    the packaging materials of the medicine

目  录
摘要
Abstract
前言 1
第一章 GMP与医药包装的背景及发展 2
1.1 GMP的来源背景与发展 2
1.2 药品包装发展 5
第二章 GMP在药品包装上的应用 7
2.1 药包材对药品的重要性 7
2.2 药包材的质量要求 7
2.3 GMP的特点及重要性 7
2.4 GMP在包装材料管理上的应用 9
2.5 我国药包材的监管趋势 9
第三章 GMP在药品包装企业的应用案例调研与分析 11
3.1 调研目的 11
3.2 企业介绍 11
3.3 调查内容与分析 13
3.4 调研总结 19
第四章 结语 21
致  谢 22
参考文献： 23
附录： 24

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