PDA TR4 注射水验证设计概念_Design Concept for Validation_WFI_1993.pdfVIP

I TechnicalReportNo. 4 技术报告 No.4 Design Conceptsforthe Validationof a Waterfor InjectionSystem 注射水验证设计概念 Sponsoredbythe QC SubcommitteeofthePDA Research Committee—F.J.Carleton,D.Conrad,R.Myers, S.Chrai,andR. Kieffer,Authors PARENTERAL DRUG ASSOCIATION, Inc. PDA METHODOLOGY 2 PREFACE 序言 THIS IS THK FOURTH TECHNICAL RKPORT dealing with the subject of process validation. The QC Subcommittee, under the direction of Frederick Carleton and Robert Kieffer, has outlined methods for evaluating a Water for Injection (WFI) System for use in pharmaceutical manufacturing. The considerations presented in this document are intended solely as a review of factors specific to the design, operation, and evaluation of a system which generally is considered to be capable of consistently delivering WFI. The method herein described is only one of the many possible alter-natives for evaluating a system. It should be kept in mind that each installation is unique, and that there are many alternative WFI systems available, each of which may require modification of this methodology. The approach followed in this procedure is limited to the most common method of producing WFI (i.e., by distilla-tion), although other methodsareacceptable. 这是涉及工艺验证的第四个技术报告。QC小组委员会根据Frederick Carleton 和 Robert Kieffer 的指导，概述了在药品生产中使用的注 射水 （WFI）系统的评价方法。在这个文件中提出的考虑，完全是 作为一个特定审核因素，用于能够持续提供注射用水系统的设计， 运行和评价。这里所介绍的方法只是评估一个系统的许多可能的选 择之一。应该牢记，每个安装都是独一无二的，有许多不同的注射 用水系统可供选择，每种可能都需要使用这种方法进行修改。遵循 此程序的方法仅限于生产注射用水最常见的方法 （即蒸馏），尽管 其他