FDA对水系统的指...doc

现场指导： 页码，1/10 GUIDE TO INSPECTIONS OF HIGH PURITY WATER SYSTEMS 高纯度水系统现场检查 Note: 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：本文件是调查员和其他FDA人员的参考资料。本文件不约束FDA，也不授予任何人任何权力、特权、利益或豁免。 This guide discusses, primarily from a microbiological aspect, the review and evaluation of high purity water systems that are used for the manufacture of drug products and drug substances. It also includes a review of the design of the various types of systems and some of the problems that have been associated with these systems. As with other guides, it is not all-inclusive, but provides background and guidance for the review and evaluation of high purity water systems. The Guide To Inspections of Microbiological Pharmaceutical Quality Control Laboratories (May, 1993) provides additional guidance. 本指南主要是从微生物方面讨论用于制剂和原料药生产的高纯度水系统的审核和评估。它还包括了对各类系统设计的审核和与这些系统相关的一些问题。和其它指南一样，它不是面面俱到的，但它提供了关于高纯水系统的审核和评价的背景和指导原则。药物微生物质量控制实验室现场检查指南（1993.5）提供了额外的信息。 I. SYSTEM DESIGN 系统设计 One of the basic considerations in the design of a system is the type of product that is to be manufactured. For parenteral products where there is a concern for pyrogens, it is expected that Water for Injection will be used. This applies to the formulation of products, as well as to the final washing of components and equipment used in their manufacture. Distillation and Reverse Osmosis (RO) filtration are the only acceptable methods listed in the USP for producing Water for Injection. However, in the bulk Pharmaceutical and Biotechnology industries and some foreign companies, Ultra Filtration (UF) is employed to minimize endotoxins in those drug substances that are administered parenterally.系统设计所要考虑的基本问题之一是要生产的产品的类型。对于注射用产品来说关心的是热原问题，所以希望使用注射用水生产。这将用于产品的配方中，同样用于产品生产的设备和部件的最终清洗过程。蒸馏法和反