浅析现行《药品生产质量管理规范》中存在的问题及对策

目的:为完善我国《药品生产质量管理规范》(GMP)提供参考。方法:结合GMP标准和GMP实施过程中出现的问题,从系统、顾客、供应商、企业负责人和文件等方面进行分析。结果与结论:GMP标准本身存在的问题影响了我国GMP工作的深入实施。为改进和优化GMP标准,建议整合过程系统,使设计质量与生产质量相匹配,构建开放的质量管理体系,强调企业负责人的引领作用,建立层次清晰、通用性强的文件系统。

Brief Discussion on the Problems in Current Good Manufacturing Practice and the Countermeasures

OBJECTIVE:To provide references for the improvement of our country's current Good Manufacturing Practice(GMP).METHODS:In consideration of GMP standards and problems in its implementation,the system,customers,suppliers,business leaders and documentation etc.were analyzed.RESULTS&CONCLUSION:Problems in the GMP standards has influenced the practice of GMP.In order to improve and optimize the GMP standards,it was recommended that process system be integrated to make the design quality in conformity with the manufacturing quality,open quality management system be established,business leader's leading effect be emphasized and clear and universal documentation system be established.