| 非无菌原料药生产设备的清洁验证 |
| |
| 引用本文： | 杨素改,张学菊. 非无菌原料药生产设备的清洁验证[J]. 中国当代医药, 2013, 0(4): 156-157 |
| |
| 作者姓名： | 杨素改 张学菊 |
| |
| 作者单位： | 秦皇岛紫竹药业有限公司;河北省秦皇岛海港区西港镇卫生院 |
| |
| 摘 要： | 本文主要对非无菌原料药生产设备清洁验证进行了总述，包括清洁验证的定义、开发、准备、实施及再验证等，为非无菌原料药生产设备清洁验证初学者提供参考。
|
| 关 键 词： | 生产设备 清洁验证 非无菌原料药 实施 |
Cleaning validation of non-sterile API |
| |
| YANG Sugai,ZHANG Xueju. Cleaning validation of non-sterile API[J]. http://www.botanicus.org/, 2013, 0(4): 156-157 |
| |
| Authors: | YANG Sugai ZHANG Xueju |
| |
| Affiliation: | 1.Qinhuangdao Zizhu Pharmaceutcal, Hebei Province, Qinhuangdao 066000, China; 2.Health Center of Xigang Town, Haigang District of Qinhuangdao City in Hebei Province, Qinhuangdao 066000, China |
| |
| Abstract: | This article is an overview of cleaning validation of non-sterile API, intending to provide references for be- giners on cleaning validation of non-sterile API. The article includes the significance of validation, the development stage of validation, preparation stage of validation, implementation of validation and revalidation. |
| |
| Keywords: | Production equipment Cleaning validation Non-sterile API Implement |
| 本文献已被 CNKI 维普 等数据库收录！ |
|
