中药制剂生产企业实施新版药品生产质量管理规范存在的问题及分析简

目的 研究2010版《药品生产质量管理规范》（GMP）实施中中药制剂生产企业质量管理存在的问题,寻找解决方法.方法 对2012年9月至12月对30家中药制剂生产企业中不同工作层面的技术人员进行自制问卷调查,对10家已进行新版GMP认证中药制剂生产企业现场检查不合格项及整改方案进行调研,并结合多年质量管理实践经验进行分析.结果与结论 目前中药制剂生产企业实施新版GMP,需分别从人员因素、硬件因素、软件因素、中药制剂的特殊性进行考虑,分别实施有效的全面质量管理,结合产品质量回顾分析和产品风险管理评估,针对中药制剂生产的全过程提出针对性的措施及建议,从而最终保证中药制剂产品的质量.

The Problems and Analysis of a New Version of the GMP in Chinese Medicine Production Enterprises

Objective To investigate the existing problems within the area of quality management of Traditional Chinese Medicine prepa- ration enterprises under the on- site version of GMP specification, to analyze the problems and find solutions. Methods The author conducted a series of researches on technical personnel of different working levels from 30 Traditional Chinese Medicine preparation en- terprises from September to December,2012,made deep investigations to the unqualified items and their rectification plans of 10 tradi- tional Chinese medicine enterprises under the on- site inspection version of GMP certification, and also committed statistical data analy- sis according to the years of practical experience in quality management and results of experimental study of the author herself. The investigation to the TCM enterprises is conducted via using self-made questionnaires, which includes the basic situation, the staff, medicine,production process and the whole process of quality management. The research results are analyzed in conclusion. Result and Conclusion At present, facing the new version of the GMP specification, traditional Chinese medicine enterprises should separately implement total and effective quality management considering such elements from the human factors,to the factors of hardware,software,as well as the speciahy of traditional Chinese medicine preparation. They should also put forward respective measures and suggestions via combining the product quality review analysis with the product- evaluation risk management for the whole process of traditional Chinese medicine preparation. In the ways above,the quality of traditional Chinese medicine products is supposed to be assured in the end.