目录1Introduction 简介 ................................................................................................................22Scope 范围 .........................................................................................................................23Glossary 术语 ..............................................................................................................................24Premises 厂房 .................................................................................................................... 45Design of HVAC systems and components 空调系统和组件的设计 ..........................................66Full fresh air systems and recirculation systems 全新风系统和再循环系统 ...............................87Air filtration, airflow direction and pressure differentials 空气过滤、气流方向和压差 ............... 88Temperature and relative humidity 温度和相对湿度 ............................................................ 109Dust, vapour and fume control 粉尘、蒸汽和烟雾控制 ........................................................ 1010Protection of the environment 环境保护 ...................................................................................1111Commissioning 试运行 ...............................................................................................................1112Qualification 确认........................................................................................................................1113Maintenance 维护........................................................................................................................121 / 141Introduction 介绍略2Scope 范围These guidelines focus primarily on GMP for the design, qualification, management andmaintenance of HVAC systems in facilities for the manufacture of non-sterile dosage forms.They are intended to complement the guidelines on GMP for pharmaceut...
