APIC 20145原料药厂清洁验证指南：5.0 清洁级别.docVIP

APIC 201405原料药厂清洁验证指南：5.0 清洁级别 5.0 Levels of Cleaning 清洁级别 5.1 Introduction 介绍 The manufacturing process of an Active Pharmaceutical Ingredient (API) typically consists of various chemical reaction and purification steps followed by physical changes. In general, early steps undergo further processing and purification and so potential carryover of the previous product would be removed. 原料药的生产工艺一般由不同化学品经过反应和纯化步骤，再经过一些物理变化组成。一般来说，较早的步骤会经进进一步处理和纯化，因此上一产品潜在的残留会被清除掉。 The level of cleaning required in order to ensure that the API is free from unacceptable levels of contamination by previous substan