GMP在藥品包裝行業中的應用

包裝工程論文編號:BZ013  論文字數:23085.頁數:35

目  錄
摘要
Abstract
前言 1
第一章 GMP與醫藥包裝的背景及發展 2
1.1 GMP的來源背景與發展 2
1.2 藥品包裝發展 5
第二章 GMP在藥品包裝上的應用 7
2.1 藥包材對藥品的重要性 7
2.2 藥包材的質量要求 7
2.3 GMP的特點及重要性 7
2.4 GMP在包裝材料管理上的應用 9
2.5 我國藥包材的監管趨勢 9
第三章 GMP在藥品包裝企業的應用案例調研與分析 11
3.1 調研目的 11
3.2 企業介紹 11
3.3 調查內容與分析 13
3.4 調研總結 19
第四章 結語 21
致  謝 22
參考文獻： 23
附錄： 24

摘  要
  GMP是人類科技進步和管理學發展的必然產物，它是適應保證藥品生產質量管理需要而產生的，在國際上已成為藥品生產和質量管理的基本準則。藥品包裝是藥品生產的繼續，是對藥品施加的最后一道工序，隨著藥品GMP管理的深入，我國食品和藥品監督管理局頒布了一系列法規，其中將藥包材作為藥品生產的輔料也納入了管理的范疇，本文通過企業案例調研分析，深入認識目前GMP在藥包材企業的實施應用狀況，指出企業實施GMP規范后存在的不足，隨著時間的推移，在對藥品包裝生產企業實施嚴格的GMP認證是遲早的事。本文所述包裝是指直接接觸藥品的包裝材料和容器，簡稱藥包材。
 
關鍵詞：GMP  藥品包裝 質量管理   藥包材 

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