APIC 的201405原料药厂清洁验证指南：4.0可接受标准.docVIP

APIC 201405原料药厂清洁验证指南：4.0可接受标准（上）（中英文） 注：本文件是由 CEFIC 的 APIC 内的清洗验证工作组制定。欧洲化学工业委员会(cefic,europeanchemicalindustrycouncil)4.0 Acceptance Criteria 可接受标准 4.1. Introduction 概述 Companies must demonstrate during validation that the cleaning procedure routinely employed for a piece of equipment limits potential carryover to an acceptable level. That limit established must be calculated based on sound scientific rational. 公司在验证时要证明各设备日常所用的清洁程序能将带入下一产品的潜在残留限制在一个可以接受的水平。所建立的限度必须进行科学合理的计算。 This section provides practical guidance as to how those acceptance criteria can be calculated. It is important that