对药品生产企业验证改进的新思路的探讨

Discussion of New Ideas of Improving Method of Reconfirming Certificate for Pharmaceutical Enterprises

目的:结合药品生产企业实际,借鉴国外先进的质量管理理念,提出了验证工作的新思路,以提高我国药品生产企业的验证水平和验证效率。方法:创新地引入生产线验证的概念,采用实例分析和理论探讨相结合的方法,将传统验证的分类标准和执行加以改进。结果与结论:传统的验证方法存在很多缺陷,必须进行改进。

Objective： Combined with the practice of pharmaceutical enterprises and advanced quality management rational employed at abroad, new idea about validation was presented to enhance the level and efficiency in validation work carried out in Chinese pharmaceutical enterprises, Method： the concept of applying production line in validation was introduced, then, by using instance analysis in conjunction with theoretical investigation, the classification standard in traditional validation was improved, Result and conclusion： there are many defects existed in the traditional validation methods, which have to be improve＆