药品生产设备清洁验证关键点的研究

Key Points of Cleaning Validation of Drug Manufacturing Equipment

目的:为药品生产企业开展清洁验证工作提供参考。方法:阐述清洁验证的概念及其重要性,并结合实例探讨在药品生产过程中如何开展设备清洁和清洁验证工作。结果与结论:在清洁及清洁验证工作中应正确选择清洁标记物、清洁溶剂、清洁方法,确定残留物限度以及允许残留物最低限度的分析方法和取样方法,并对分析方法、取样方法进行验证。清洁验证是降低药品污染、提高药品质量的有效途径,药品生产企业应重视这项工作。

OBJECTIVE：To provide reference for drug manufacturers to carry out cleaning validation.METHODS：The concept and importance of cleaning validation were interpreted,and the way to carry out equipment cleaning and cleaning validation during the production process was investigated on the basis of examples.RESULTS CONCLUSIONS：During cleaning and cleaning validation,cleaning makers,cleaning solvent,cleaning methods,residue limits and analytical methods should be selected correctly;besides,analytical methods and sampling methods should be validated.Cleaning validation is an effective way to reduce contamination and improve drug quality.Drug manufacturers should pay more attention to this job.