国际制药协会ISPE基础指南03卷.pdf

A GUIDE FOR NEW FACILITIES VOLUME 3: STERILE MANUFACTURING FACILITIES EXECUTIVE SUMMARY June 2000 A DOCUMENT DEVELOPED IN PARTNERSHIP BY: ISPE BASELINE® GUIDE STERILE MANUFACTURING FACILITIES JUNE 2000 2 ISPE BASELINE® GUIDE STERILE MANUFACTURING FACILITIES JUNE 2000 ISPE PHARMACEUTICAL ENGINEERING GUIDE STERILE MANUFACTURING FACILITIES FOREWORD As noted in the Baseline® Guides, Volume 1, the pharmaceutical industry has experienced a ratcheting effect in the cost of new facilities. This increase in cost has 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, architectural and HVAC. The absence of a consistent and widely accepted interpretation of 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. 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). That first discussion allowed for the creation of 12 facility engineering guides, now known as the Baseline® Pharmaceutical Engineering Guides. These guides are intended to assist pharmaceutical manufacturers in the design, construction an