借鉴ISO9001标准完善我国药品GMP制度

Developing our drug GMP system by using ISO9001 standards for reference

目的完善我国GMP制度。方法比较ISO9001与我国GMP的联系与区别。结果及结论提出借鉴ISO9001的先进理念,改进我国GMP制度,促进药品企业的质量管理。

OBJECTIVE Perfecting China＇s GMP.METHODS Compares the difference and association between ISO9001 and GMP.RESULTS and CONCLUSION Analysis of the ISO9001 standard from the guiding ideology to the advancement of the specific content,improving these aspects of China＇s GMP,to advamce quality management of drug enterprises.