对中国2010版《药品生产质量管理规范》中清洁验证的分析

按照2010版药品生产质量管理规范(GMP)第一百四十三条要求:清洁方法应当经过验证,证实其清洁的效果,以有效防止污染和交叉污染。清洁验证应当综合考虑设备使用情况、所使用的清洁剂和消毒剂、取样方法和位置以及相应的取样回收率、残留物的性质和限度、残留物检验方法的灵敏度等因素。就GMP中相应的条款进行解读分析,以便更好的理解本条款和用最恰当的实施措施满足法规要求,进一步加大降低药品交叉污染的风险。

Cleaning Validation Analysis in Chinese Good Manufacturing Practice （2010 Version）

According to the requirements of clause 143 in Chinese Good Manufacturing Practice（2010 version）,cleaning methods should be validated to confirm their effect and prevent contamination and cross-contamination effectively.Cleaning validation should comprehensively consider related factors including the use of equipment,cleaning agents and sanitizer,sampling methods and positions as well as relevant recovery rate,residues properties and limits,sensitivity of residue testing methond and so on.Comprehend the corresponding clauses in GMP to get a better understanding of this clause,and meanwhile take the most appropriate washing method to further decrease the risk of cross-contamination.