FDA清洁验证检查指南-翻译和解读.pdfVIP

翻译：Cuckoo (cuckoo801002@); 校对并解读：Chank (chank2006@) 注：个人学习、交流使用，不得用于商业目的。 Validation of Cleaning Processes (7/93) 清洁工艺验证 GUIDE TO INSPECTIONS VALIDATION OF CLEANING PROCESSES 清洁工艺验证检查指南 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：此指南是 FDA 检查官和其工作人员的参考资料。此文件不约束 FDA，也不赋予任 何人任何权利，特权，利益或豁免权。 I. INTRODUCTION 介绍 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. 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 validation, 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 as expected and produces a result that consistently meets predetermined specifications. This guide is intended to cover equipment cleaning for chemical residues only. 自从 FDA 的各文件，包括化学原料药检查指南和生物技术检查指南简单地提出了清洁 验证这个话题之后，关于清洁工艺的验证已经引发了相当多的讨论。这些官方的文件， 都清楚地确定了对于清洁工艺需要被验证的期望。 通过讨论那些已被认为可接受的（或者不可接受的）实际情况，此指南是为了建立检查 的连贯一致性。同时，必须意识到，与其他工艺验证一样，清洁验证的方法也不止一种。 最后，所有过程验证的检查标准是，检查其科学数据能否证明该系统始终如一地达到预 期目的，结果稳定地符合预先制定的标准。 本指南仅适用于设备的化学残留物的清洁验证。 II. BACKGR