摘要
按照《药品生产质量管理规范》(简称"GMP")的要求,需对生产用设备进行清洗验证,以防止药品生产过程中的污染和交叉污染。尤其对于同一设备生产多个品种时,选择最难清洗的产品、制定最低的允许残留限度进行清洗验证,既能达到证明清洁程序的有效、防止交叉污染的目的,也能达到优化清洁程序、减少清洗验证工作量的目的,防止差错的发生。
According to ＂Good Manufacturing Practice＂ （hereafter referred to ＇GMP＇）, the cleaning validation should be carried out to prevent the contamination and cross contamination during manufacturing. Especially for the multi-products, select insoluble products to conduct the cleaning validation and make the lowest residue limits to verify the effectiveness of validation and prevent cross-contamination. Optimize the cleaning validation for multi- products, reduce the cleaning validation work and prevent mistakes occurring.
出处
《广东化工》
CAS
2013年第4期26-27,共2页
Guangdong Chemical Industry
关键词
多品种
制药设备
清洗验证
multi- produets equipment
cleaning validation
