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新药政下 CP 公司矿物中药饮片质量管理研究
工商管理 专业
研究生：雍建国 指导教师：黄宇峰
摘要：新药政近几年，我国制药产业发展迅速，为了适应人们对健康卫生要
求的提高，规范制药欧亿·体育（中国）有限公司发展，我国卫生部于 2010 年 10 月 19 日审议通过了新版
GMP，并于次年 3 月 1 日起开始实施。新 GMP 的产生有其特定的发展背景，它与旧
GMP 相比，提升了药品生产环境标准，增加了检测项目，完善的质量管理环节，同
时还要求企业要建立相关的风险防范体系、质量管理体系、药品跟踪评价体系等。

新 GMP 的实施使我国制药产业出现了一次大洗牌，制药企业数量锐减，但是在洗
牌之后，制药产业将开始蓬勃发展。

本文首先对我国饮片生产企业的现状进行了调查研究，提出制药企业进行药
品质量管理是企业发展的需要，是饮片监管形式所迫，然而，我国中药饮片存在
的问题严重、突出，而新 GMP 的实施为有效的解决这些问题提供了途径。本文再
次分析药品质量管理在国内外的发展现状，分析了药品质量管理在我国的发展历
史。结合 CP 公司的实际情况，分析了公司在 MX 矿物中药饮片管理上存在的问题，
对其产生问题的原因进行了探讨，论述了这些原因的出现多是不符合新 GMP 要求
所致。CP 公司认识到自身的问题，针对 MX 中药饮片制定了全面的质量改进方案。

最后，本文还对矿物中药饮片质量管理的延伸进行了探究。

关键词：新药政 矿物中药饮片 质量管理III
The Researching of Quality Control forCompanyCP's Prepared Slices
of Chinese Mineral Crude Drugs under The New Pharmaceutical Cont
rol and Administration
Major:MBA
Author:Yong Jianguo Advisor:Huang Yufeng
Abstract: A new drug in recent years, China's pharmaceutical industry is
developing rapidly, in order to meet the people to the health demand improved,
regulating the pharmaceutical industry development, China's Ministry of health in
October 19, 2010 considered and adopted the new version of GMP, and begin to
implement from January 1st of the year following the. The new GMP has its special
background, it is compared with the old GMP, enhance the pharmaceutical production
and environmental standards, increased testing, quality management and perfect, but
also requires enterprises to establish risk prevention system, quality management system,
the drug evaluation system. The implementation of the new GMP is that the
pharmaceutical industry in China experienced a major reshuffle, the sharp drop in the
number of pharmaceutical companies, but in the shuffle, pharmaceutical industry began
to flourish.
Firstly, the present situation of our pieces of production enterprises to conduct the
investigation and study, puts forward the pharmaceutical enterprises tablets quality
management is the need of enterprise development, is the pieces regulation forced by
the form, however, there are serious problems in China Chinese medicine Yinpian,
prominent, and the implementation of the new GMP to provide a way to solve these
problems effectively. In this paper, analysis of drug quality management development
status at home and abroad, analysis of drug quality management development history
in china. Combining the actual situation of CP company, analyzes the existing
companies in MX mineral Chinese medicine management problems, causes of problems
on it were discussed, the appearance of these reasons are not conforming to the new
requirements of GMP induced. CP company realize its own problems, according to the
MX pieces of Chinese medicine a comprehensive quality improvement plan. Finally,
this paper also extends to the quality management of mineral Chinese medicine Yinpian
were studied.
Keywords: new drug mineral Chinese medicine quality management