洛施德GMP咨询 - EU_GMP指南第1部分第3章：厂房和设备.pdfVIP

Soltoris Management Consultants, Inc. 洛施德企业管理咨询（上海）有限公司 EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use Part 1 Chapter 3: Premises and Equipment 人药和兽药GMP 指南 第1 部分第3 章：厂房和设备 第 1 页 / 共 7 页 , Soltoris Management Consultants, Inc. info@ Soltoris Management Consultants, Inc. 洛施德企业管理咨询（上海）有限公司 Principle 原则 Premises and equipment must be located, designed, constructed, adapted and maintained to suit the operations to be carried out. Their layout and design must aim to minimise the risk of errors and permit effective cleaning and maintenance in order to avoid cross-contamination, build-up of dust or dirt and, in general, any adverse effect on the quality of products. 厂房和设备的位置、设计、结构、改建和维护保养应适合于所进行的操作。为了避免交叉污染、灰尘或污垢 以及其它影响产品质量的因素，厂房和设备的而已及设计应使产生误差的危险减至最低限度，并易于有效的 清洁和维护保养。 Premises 厂房 General 概述 3.1 Premises should be situated in an environment which, when considered together with measures to protect the manufacture, presents minimal risk of causing contamination of materials or products. 厂房的位置选择应考虑其环境能保证生产，同时又可使对物料或产品产生污染的危险减至最低。 3.2 Premises should be carefully maintained, ensuring that repair and maintenance operations do not present any hazard to the quality of products. They should be cleaned and, where applicable, disinfected according to detailed written procedures. 厂房的维护工作应细致，以确保在维修和维护保养操作中不会危及产品质量。应按照详细的书面操作规 程对厂房进行清洁和必要的消毒。 3.3 Lighting, temperature, humidity and ventilation should be appropriate and such that they do not adversely affect, directly or indirectly, either the medicinal products during their manufacture and storage, or the accurate functioning