CQI在GMP文件管理中应用的探讨

目的对药品生产文件持续改进工作的开展进行初步探讨。方法介绍根据持续改进的理论和药品生产文件的特点,结合GMP的精神和质量保证的要求,阐述持续改进在药品生产文件管理中的重要意义,并提出具体的实施方法。结果与结论在药品的生产文件管理中,持续改进是提高其运作水平的重要途径。

Discussion on application of CQI in the GMP Document Management

Objective Have a primary exploration on the continual improvement of production documentation for drug manufacturing.Methods Based on theories of continual improvement and features of production documents for drug manufacturing,and with integration of GMP values and requirements of quality assurance,elaboration is made on the importance of continual improvement in document management for drug production,and specific methods are proposed hereby.Results and Conclusions In the document management for drug production,and specific methods are proposed hereby. Results and Conclusions In the document management for drug production, continual improvement is an important approach to enhance the level of operation.