摘要
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。
OBJECTIVE： To provide references for the improvement of our country＇ s current Good Manufacturing Practice （GMP）. METHODS ： In consideration of GMP slandards 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.
出处
《中国药房》
CAS
CSCD
北大核心
2005年第17期1289-1291,共3页
China Pharmacy
关键词
药品生产质量管理规范
问题
对策
Good Manufacturing Practice
Problems
Countermeasures
