制药用水和蒸汽系统指南.docVIP

A GUIDE FOR NEW FACILITIES 为新型设施准备的指南 VOLUME 4: WATER AND STEAM GUIDE卷4：水和蒸汽系统的指导原则 EXECUTIVE SUMMARY执行概况 DECEMBER 20002000年12月 A DOCUMENT DEVELOPED IN PARTNERSHIP WITH FDA 本文件由下列单位与FDA合作编写 ISPE PHARMACEUTICAL ENGINEERING GUIDE/ISPE制药工程指南 FOREWORD /序 For many years, the pharmaceutical industry has experienced increases in the cost of new facilities. These increases in cost have been driven in part by uncertainty about the requirements for regulatory compliance. Some significant areas of concern are validation, particularly related to automation systems, and the trend to validate back to source utilities. The absence of a consistent and widely accepted interpretation of some regulatory requirements has led to one-upmanship. This practice of building increasingly technically advanced facilities has led to increased cost, longer lead times and, in some cases, delays in bringing new products to market. 长年以来，制药行业在购进的大量新设施方面的支出一直持续增长。造成这些支出的部分原因是法规符合力度的要求的无常。验证是得到重点关注的方面之一，特别是与自动化系统、回溯验证源效用的趋势、建筑和HVAC有关的内容。一致且得到广泛接受的法规要求的欠缺造就了突出的情况：对技术先进的设施的追求导致成本的剧增、交货与订货之间所需时间的延长、以及，在某些情况下，可导致新产品上市的延期。 In May 1994, engineering representatives from the pharmaceutical industry engaged in a discussion with the International Society for Pharmaceutical Engineering (ISPE) and the Food and Drug Administration (FDA). As a result of that discussion in November 1994, ISPE began work on 10 facility engineering Guides, now known as the Baseline? Pharmaceutical Engineering Guides. The first, “Bulk Pharmaceutical Chemicals,” was published in June 1996. The second, “Oral Solid Dosage Forms,’” was published in February 1998. The third, “Sterile Manufacturing Facilities,” was published in February 1999. This is the fourth such Guide, covering Pharmaceutical Water and Steam Systems. Each Engineering Guide was created by, and is owned solely by ISPE. FDA provided comments on this and previous Guides, and many of their suggestions have been incorporated. 1994年5月，制药行业的技术代表与国际制药工程协会（ISPE）和美