关键词: font-size:medium, ">清洁验证；活性物质残留限度标准；基于健康的暴露限度

Abstract: Objective：Cleaning validation is an important measure to reduce the risk of contamination and cross-contamination during drug production. The active pharmaceutical ingredient residue limit is an important criterion in cleaning validation and a key indicator for judging whether the cleaning method is effective. In the development process of the pharmaceutical industry， there have been many different calculation methods and standards for the residues limit in cleaning verification， each with different application scopes， advantages and disadvantages. In this paper， the different calculation methods of the residue limits are introduced， and the factors that need to be considered in the selection and application of different limit standards are discussed.

Key words: font-size:medium, ">Cleaning validation；Acceptance criteria of active pharmaceutical ingredient Residues；Health based exposure limits