摘要
目的探索当前形势下将质量风险管理融入药品GMP管理的最佳途径和方法。方法通过对2010年版GMP及其中质量风险管理条款的理解,结合质量风险管理在GMP具体应用中存在的问题,从药品生产企业的角度对其进行分析及探讨。结果与结论风险管理是药品质量管理体系更加完善的产物;有效的质量风险管理必须建立在顺畅运行的质量保证体系基础之上;而人为因素是质量风险管理的关键所在。具体运用中要注重风险管理的前瞻性和回顾性方式,以减少事件或过程中的不确定因素,进而避免陷入无尽的风险评估事物之中。质量风险管理的应用需要一个循序渐进的过程,最终经过制度化、常态化的良性运行方可达到预期目的。
Objective To explore the best ways and means to integrate the quality risk management （QRM） into the good manufacturing practice （GMP） implementation. Methods The new version of GMP with its provisions on QRM was analyzed and discussed from the view of pharmaceutical production companies, based on carrent understanding and the specific problems in the application of QRM in GMP implementation. Results and Conclusion QRM is the product of perfecting the pharmaceutical quality management system. Effective QRM should be built on the smooth running of quality assurance system, and human factor is the key to effective implementation. Specific attention should be paid to the prospective and retrospective ways of QRM in practice to reduce the uncertainties in the events or processes and avoid the endless risk assessments. The application of QRM should follow a step-by-step process, until the intended purposes are achieved by institutionalized and normalized benign operation.
出处
《中国药事》
CAS
2013年第10期1097-1099,共3页
Chinese Pharmaceutical Affairs
