FDA清洁验证指南(中英文对照)VIP专享

1 o f 14 Validation of Cleaning Processes 清洁工艺验证 GUIDE TO INSPECTIONS VALIDATION OF CLEANING PROCESSES 清洁工艺验证检查指南 Mike Ma Sort out Xiao Gang Note: This document is reference material for investigators and other FDA personnel. The document does not bind FDA, and does no confer any rights, privileges, benefits, or immunities for or on any person(s). 注意：本指南是审计官和其他FDA人员的参考资料。FDA不受本指南的约束，也没有授予任何人任何权利、特权、收益或豁免权。 2 of 14 Content I. INTRODUCTION 简介 ............................................................................................................................................... 3 II. BACKGROUND 背景 ................................................................................................................................................ 3 III. GENERAL REQUIREMENTS 常规要求 .................................................................................................................... 5 IV. EVALUATION OF CLEANING VALIDATION 清洁验证的评估 .................................................................................. 6 V. ESTABLISHMENT OF LIMITS 确定限度 ................................................................................................................. 11 VI. OTHER ISSUES 其他问题 ..................................................................................................................................... 12 VII. REFERENCES 参考资料 ....................................................................................................................................... 13 3 o f 14 I. INTRODUCTION 简介 Validation of cleaning procedures has generated considerable discussion since agency documents, including the Inspection Guide for Bulk Pharmaceutical Chemicals and the Biotechnology Inspection Guide, have briefly addressed this...