摘要
2011—2016年,美国FDA共向中国制药公司发出43封警告信。信中指出的问题涵盖了美国FDA在检查中国制药公司时所发现的生产管理和产品质量的各种问题。分析警告信内容,跟踪制药工业产品质量控制的趋势,发现普遍存在的问题,并根据美国FDA的监管重点,指出企业在质量管理体系方面存在的问题和改进办法。
From the year 2011 to 2016, the United States Food and Drug Administration （FDA） issued 43 warning letters to China pharmaceutical companies. These warning letters covered the issues of pharmaceutical manufacture management and product quality discovered during FDA＇s inspection of China pharmaceutical companies. This article studied the content of these warning letters in order to track the trend of quality management in pharmaceutical industry and discover common issues, It also analyzed the issues of the quality system in China phamaaceutical companies and the way of improvement from the US FDA＇s viewpoints.
出处
《药学进展》
CAS
2017年第9期710-716,共7页
Progress in Pharmaceutical Sciences
