2013年山东省新修订药品GMP认证检查情况分析

国家于2011年3月1日正式颁布实施《药品生产质量管理规范（2010年修订）》,并给予制药企业五年的过渡期.从本年度（2012年11月－2013年10月）的检查情况看,企业在执行新版GMP规范过程中尚存一定不足.本次调研旨在通过对本年度检查缺陷项目的调查、分析,并与上一年度检查情况对比,及时发现实施新修订药品GMP的企业出现的共性缺陷问题,为药品监管系统制定针对性的监管措施,科学的进行质量风险评估,为药品生产企业更加规范的执行实施新版GMP规范提供技术依据.

Analysis on the situation of revised drug GMP certification inspection for Shandong Province in 2013

Since March 1 st in 2011, the Good Manufacturing Practice（ revised 2010） had formally promulgated and im- plemented and also allowed a five - year transition period for pharmaceutical enterprises, in the analysis on the situation of the eertifieation inspeetion from 2012. 11 to 2013.10,there are some defieieneies for pharmaceutical enterprises in imple- mentation of new revised drug GMP. This researeh aims to diseover the eommon defieieneies of implementation in enterprises of revised drug GMP timely by eompared the results of inspeetion in last two years. At the same time,the researeh provides the speeifie ideas and seientifie assessment of quality risks for drug regulatorT system, also teehnical basis for pharmaceutical enterprises to carry out the new revised GMP more normally.