药品生产质量管理探索研究

摘要

药品作为一种特殊的商品,其质量安全关乎消费者的人身安全和健康情况,所以具有很高的质量标准.药品质量是生产出来的而不是检验出来的,因此药品

生产中的质量控制在药品质量安全管理中占有主要的地位. 目前，在我国的药品生产中，还存在着一些问题，这些问题给药品的安全生产造成了一定的安全隐患。本文的研究目的是通过对药品生产质量控制要点的理解和研究,把握药品生产中质量控制的要点,加强对其的整体认识和理解，加强细节注意和把控，从而在药品的生产中采取严格的质量管理措施。结论:通过对质量管理机制和要点的分析之后,需要在实际生产中从员工意识、过程的监督、质量体系建设、人才队伍的管理、企业文化的建设等各方面来进行全面控制。

关键词　药品生产 质量管理 健全 监督 服务

目录

摘要······························································Ⅰ

第1章药品质量管理的定义··········································1

1.1药品质量管理的概念 ············································1

1.2药品质量管理理念的发展历程·····································2

第2章质量管理的要素··············································3

2.1人·····························································3

2.2机·····························································3

2.3料·····························································3

2.4法·····························································4

2.5环·····························································4

第3章药品质量管理现状············································5

3.1理念的现状·····················································5

3.2体系还有待健全·················································5

3.3相关法律法规需要进一步完善·····································5

3.4管理人员的能力要更上一层楼·····································6

第4章 药品生产中的质量控制点·····································7

4.1加强员工质量意识···············································7

4.2强化生产过程的监督和控制·······································7

4.3建立全面的质量管理体系·········································8

4.4加强人才队伍的建设和管理·······································8

4.5加强企业文化的建设·············································9

5结论····························································10

参考文献··························································11

致谢··························