浅谈原料药年度质量回顾的编写方法

Brief Discussion of Annual Review for Quality of Active Pharmaceutical Ingredients

介绍了产品年度质量回顾在制药企业质量管理和GMP、FDA、COS迎接认证检查中的重要性,详细地介绍了如何编写原料药产品年度质量回顾。

In this article,the importance of annual product quality review in pharmaceutical enterprise quality administration and certification inspection with GMP,FDA and COS was introduced,and the method of writing annual product quality review was also described in detail.