CAJ | 학술논문

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。
안조2010판약품생산질량관리규범（GMP）제일백사십삼조요구：청길방법응당경과험증，증실기청길적효과，이유효방지오염화교차오염。청길험증응당종합고필설비사용정황、소사용적청길제화소독제、취양방법화위치이급상응적취양회수솔、잔류물적성질화한도、잔류물검험방법적령민도등인소。취GMP중상응적조관진행해독분석，이편경호적리해본조관화용최흡당적실시조시만족법규요구，진일보가대강저약품교차오염적풍험。
According to the requirements of clause 143 in Chinese Good Manufacturing Practice (2010 version), cleaning methods should be validated to conifrm 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.