方案摘要
方案下载| 应用领域 | |
| 检测样本 | |
| 检测项目 | |
| 参考标准 |
1,FDA关于清洁验证的目的: “The purpose of cleaning validation is to demonstrate that a particular cleaning process will consistently clean the equipment to a predetermined limit; the sampling and analytical test methods should be scientifically sound and provide adequate scientific rationale to support the validation”. 2,清洁验证的历史 1963 GMP Regulations: "Equipment shall be maintained in a clean and orderly manner.” 1978 cGMP Regulations: Section 211.67 added describing equipment cleaning and maintenance. 1993 FDA guided to inspections for cleaning validation. 2002 Pharmaceutical cGMP’s for the 21st century: A risk based approach.
文献贡献者
各种背景修正方式的比较
原子吸收光谱仪器应用
分析天平的使用方法
相关产品
关注
拨打电话
留言咨询
