制药企业实施新版GMP存在的问题与应对措施

Pharmaceutical Companies to Implement New GMP Issues and Countermeasures Exist

新版GMP实施后,制药企业在执行时都存在着不同问题。结合作者的工作经验,并参考相关文献后,对制药企业执行新版GMP存在的问题进行了归纳探讨,并根据自身的质量管理经验提出了相应的应对措施。

After the implementation of new GMP,pharmaceutical companies in the implementation there are different problems. After binding the author’s work experience,and with reference to the relevant literature on the implementation of the new GMP pharmaceutical companies the problems were summarized discussed,and based on their experience in quality management proposed the corresponding countermeasures.