重视和做好药品GMP重新认证工作

Pay Close Attention to the Anew Authentication of Drugs GMP

目的为做好GMP重新认证工作,执行好新标准,进一步巩固和提高药品GMP水平提供参考。方法通过比较药品重新认证和首次认证的不同,分析GMP认证企业存在的主要问题。结果提出了重新认证现场检查应关注的重点内容。结论药品GMP认证是药品安全监管和药品质量源头控制的重要措施。

Objective To provide some consultations for the anew authentication to execute the new criterion, consolidate and improve the standard of drugs GMP. Methods By comparing the first authentication against the anew authentication, analyze the principal problem of enterprises. ResuLts put forward the major contents that we must pay attention to in examining the spot of anew authentication. Conclusions The anew authentication of drugs GMP is an important measure for the drugs safety supervision and the source control of drugs quality.