美国fda认证与申办指南.pdfVIP

《美国FDA 认证与申办指南》 清洗过程验证检查指南 GUIDE TO INSPECTIONS VALIDATION OF CLEANING PROCESSES 正大资询 清洗过程验证检查指南 GUIDE TO INSPECTIONS VALIDATION OF CLEANING PROCESSES 请注意：本指南是检查官和其他 FDA 人员的参考材料。本指南不 受 FDA 约束，并没有赋予任何人任何权利、特权、收益或豁免权。 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). I．介绍 INTRODUCTION 自从机构文件，包括原料药化学制剂检查指南和生物制剂检查指 南，大体上提到该清洗 问题以来，就出现了关于清洗过程验证的大量 讨论。这些机构文件清晰的建立了要验证的清洗过程需要达到的要求。 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. 本指南是为了通过讨论实际操作是可接受的(或不可接受的)，来 建立检查要求的一致性和统一性。同时，对清洗验证需要了解的是，像 其他过程验证一样，可能有不止一种方法来对过程进行验证。最后，任 何验证过程的测试就是指科学数据是否显示出系统与要求相符和产 生的结果是否符合预先定义的参数指标。 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. 本指南只适用于化学残留物的设备清洗。 Thi