FDA清洁验证指南(中英文对照).pdf

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。 1 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 2 of 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 issue. These Agency documents clearly establish the expectation that cleaning procedures (processes) be validated. 自从机构文件，包括化学原料药制剂检查指南和生物技术制剂检查指南简明的提及清洁验证规程以来，就 对清洁规程验证产生了大量的讨论。这些机构的文件明确建立了清洁规程验证的预期结果。 This guide is designed to establish inspection consistency and uniformity by discussing practices that have been found acceptable (or unacceptable). Simultaneously, one must recognize that for cleaning validatio n, as with validation of other processes, there may be more than one way to validate a process. In the end, the test of any validation process is whether scientific data shows that the system consistently does a