摘要
目的为原料药生产企业实施新版药品GMP和进一步完善质量管理体系提供参考。方法对125家次原料药生产企业在新版药品GMP认证中发现的缺陷情况和主要问题进行了统计和分析。结果与结论原料药生产企业应在质量管理体系、人员培训、验证管理和文件管理等方面,规范各项药品生产质量管理活动。
Objective To provide a reference for the API manufacturers when implementing the new China GMP regulation and carrying out the further improvement. Methods A statistical analysis was conducted on all defects found in 125 API manufacturers who received the new GMP inspection recently. Results and Conclusion The API manufacturer should standardize each pharmaceutical production activity according to new GMP with more effort on quality management system,personnel training,validation management and document management.
出处
《中国药事》
CAS
2014年第9期963-966,共4页
Chinese Pharmaceutical Affairs
