中小型制药企业GMP实施问题及策略 (2).docx

PAGE PAGE 1 贵州医科大学神奇民族医药学院 本科毕业论文（设计） 论文（设计）题目：中小型制药企业GMP实施问题及策略 学 院：＿＿＿＿＿＿＿＿ 专 业：＿＿＿＿＿＿＿＿ 班 级：＿＿＿＿＿＿＿＿ 学 号：＿＿＿＿＿＿＿＿ 学生姓名：＿＿＿＿＿＿＿＿ 指导教师：＿＿＿＿＿＿＿＿ 年 月 日  中小型制药企业GMP实施问题及策略 摘要 药品是保证人民生命健康的特殊产品，药品质量管理具有特殊的重要性。药品GMP通过对药品生产全过程进行规范管理，确保制药企业遵循科学、系统的行业准则和行为规范，保证药品质量，维护人民群众用药的安全有效。同时，只有彻底解决中小型制药企业的GMP实施问题，才能从根本上实现医药产业整体升级，促进我国制药企业国际竞争力的提升。为了分析我国中小型制药企业GMP的实施现状，找到中小型制药企业GMP实施中的本质问题，本文采取了文献检索、归纳总结、定性与定量结合的研究方法，探讨了药品GMP相关的概念和理论基础，指出我国我国中小型制药企业GMP实施的现状及其实施过程中存在的具体问题，并结合相关的理论成果，针对问题提出有效解决的策略，从而有利于建立有效的GMP实施机制，促进我国中小型制药企业健康有序的发展。 关键词：药品GMP；中小型制药企业；有效实施；问题与策略  GMP implementation issues and strategies for small and medium-sized pharmaceutical companies Abstract Medicines are special products that guarantee peoples life and health, and the quality management of medicines has special importance. GMP Pharmaceuticals regulates the entire production process of pharmaceuticals to ensure that pharmaceutical companies follow scientific and systematic industry standards and codes of conduct, to ensure the quality of pharmaceuticals, and to maintain the safety and effectiveness of medicines used by the people. At the same time, only by thoroughly solving the GMP implementation problems of small and medium-sized pharmaceutical companies can we fundamentally realize the overall upgrading of the pharmaceutical industry and promote the improvement of the international competitiveness of Chinese pharmaceutical companies. In order to analyze the current status of GMP implementation in Chinas small and medium-sized pharmaceutical companies, and to find the essential problems in the implementation of GMP in small and medium-sized pharmaceutical companies, this article adopts research methods of literature retrieval, induction and summary, and qualitative and quantitative research, and discusses the concepts and theories related to pharmaceutical GMP Based on this, the current status of GMP implementation in Chinas small and medium-sized pharmaceutical companies and the specific