APIC201405原料药厂清洁验证指南：40可接受标准.docVIP

APIC 20140?5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?,europ?eanch?emica?lindu?stryc?ounci?l)4.0 Accep?tance? Crite?ria 可接受标准? 4.1. Intro?ducti?on 概述 Compa?nies must demon?strat?e durin?g valid?ation? that the clean?ing proce?dure routi?nely emplo?yed for a piece? of equip?ment limit?s poten?tial carry?over to an accep?table? level?. That limit? estab?lishe?d must be calcu?lated? based? on sound? scien?tific? ratio?nal. 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 secti?on provi?des pract?ical guida?nce as to how