生化药品GMP附录实施情况的分析与探讨

Analysis and Discussion of Implementation of GMP Annex for Biochemical Drugs

目的:《药品生产质量管理规范》(2010年修订)生化药品附录的颁布和实施,对生化药品生产企业提出了新要求。本文对生化药品GMP附录的实施情况进行了分析,对如何进一步推进生化药附录的实施提出了建议。方法:通过对附录实施前后国内生化药品检查情况汇总分析,阐述部分生化药品生产企业还存在一些薄弱环节,建议从生化药品生产企业贯彻落实GMP附录和进一步加强生化药品生产监管工作两方面加以推进。结果与结论:生化药品生产企业的质量管理与生化药品附录的要求存在一定差距,尤其是在供应链管理方面。在药品监督检查中,必要时应进行延伸检查,从源头进行监管。

Objective： The new annex of Good Manufacturing Practice（2010 Revision）, which is for biochemical drugs, has put forward many new requirements for biochemical drug manufacturing companies. This paper analyzed the implementation of the new annex for biochemical drugs and put forward suggestions on how to further promote the implementation of the new annex for biochemical drugs. Methods： Inspection results of domestic biochemical drugs before and after the implementation of the new annex were analyzed, which brought forward the conclusion that there were still some gaps between the expectation of the annex and the current situation. It is suggested that the biochemical drug production enterprises should implement the annex as soon as possible, and the drug supervision and administration organizations should further strengthen the supervision. Results and Conclusion： There is still a certain gap between the quality management of biochemical drug manufacturing companies and the requirements of the new annex for biochemical drugs, especially in the aspect of supply chain management. Therefore, additional inspection should be carried out in drug supervision and inspection when necessary and supervision should be conducted from the source.