第一章 PDATR-29清洁验证中英对照(序目录).pdfVIP

Preface 序 This document provides guidance relative to the validation of cleaning for a broad range of processing systems and product types within the pharmaceutical industry. This effort commenced in 1991 in conjunction with individuals representing the biotechnology community. Early on it was agreed to separate the development of cleaning validation guidance into biotechnology and pharmaceutical segments. The committees worked in parallel for a number of years and shared early drafts to ensure that what would be produced by each committee would be compatible. The biotech effort culminated in PDAs 1995 publication of Cleaning and Cleaning Validation: A Biotechnology Perspective. The pharmaceutical committee continued the development of its document after the publication of the biotech effort, and completed its stand alone guidance in the fall of 1997. 本文件旨在作为制药设备清洁验证的指南，以配合制药工业中范围宽广的生产系统及产 品类型。本小组自1991年起致力于本文件的撰写，当时开始与生物技术工作人员共同工 作。工作初期，大家认同把清洁验证的研究按“生物科技”和“制药”区分处理；在数 年间两组人员平行进行相关的开发工作，并相互共享初期所拟定的草案，以保证两方面 意见相同的事项。PDA于1995年将“生物技术”方面的研究所得出版为Cleaning and Cleaning Validation: A Biotechnology Perspective 。制药方面的研究小组随后继续研究， 于1997年秋季完成起研究工作。 Our goal had always been to outline cleaning validation practices across a range of equipment, process, and product applications and the inclusion of this flexibility was certainly a factor in the length of time it took to complete this effort. During the course of assembling this document, we recognized the commonality of certain themes, issues, and concerns relative to cleaning and cleaning validation across the industry. We also realized that in order to apply the principles in different operating settings, that some narrowing of the document would be necessary. As a result, we have included perspectives on the applica