FDA清洁验证指南.doc

FDA 清洁验证指南 （转载中英文）?? 2013-01-09 16:52:25|??分类：?FDA|字号?订阅 Validation of Cleaning Processes?清洁工艺验证GUIDE TO INSPECTIONS VALIDATION OF CLEANING PROCESSESNote: 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。本指南不约束FDA，也没有授予任何人任何权利、特权、收益或豁免权。 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 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.设计本指南是为了通过讨论已发现的可接受（或不可接受）的实际操作来建立检查的一致性和统一性。同时必须认识到清洁验证和其他过程验证一样，某一过程的验证可能不止一种方式。最后，任何过程验证的检测是科学数据是否反映系统能始终如一按照既定标准运作并持续产生符合既定标准的结果。 This guide is intended to cover equipment cleaning for chemical residues only.本指南只适用于化学残留物的设备清洁。 II. BACKGROUND 背景For FDA to require that equipment be clean prior to use is nothing new, the 1963?GMP?Regulations (Part 133.4) stated as follows Equipment *** shall be maintained in a clean and orderly manner ***. A very similar section on equipment cleaning (211.67) was included in the 1978 CGMP regulations. Of course, the main rationale for requiring clean equipment is to prevent con