辽宁省新修订药品GMP认证检查质量保证方面存在的缺陷及改进建议

Defects and Recommendation for Improvement of Quality Assurance of the Revised Drug GMP in Liaoning Province

目的:对本省GMP认证检查过程中发现的缺陷进行汇总,以供业内借鉴和参考。方法:对本省自2011年3月以来进行的145家次认证检查中发现的质量保证方面存在的缺陷进行归类分析。结果与结论:多数药品生产企业对于新修订药品GMP新增质量保证方面的条款理解不充分,执行不到位,应逐步完善相应的质量管理体系,从而更有效地控制产品潜在的风险。

Objective： To summarize the defects in the certifi cation process of Liaoning province, so as to provide a reference for the industry. Methods： The quality assurance defects in the certification reports of 145 since March 2011 were analyzed and classified. Results and Conclusion： Most of drug manufacturing enterprises＇ understanding at the new quality assurance items in the revised Drug GMP is not enough and the implementation is not in place. They still need to improve their quality management system gradually, so to control the potential risk of products more effectively.