世界卫生组织HVAC非无菌制药指南(中英对照)WHO-937.doc

WHO 937 Annex 附件2 Supplementary guidelines on good manufacturing practices for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms 在GMP的基础上补充指导药剂生产的供暖，通风，空调系统的指导条例。 1. Introduction 介绍 2. Scope of document 文本范围 3. Glossary 术语表 4. Protection 保护 4.1 Products and personnel 产品和人员 4.2 Air filtration 空气过滤 4.3 Unidirectional airflow 单向空气流 4.4 Infiltration 渗透 4.5 Cross-contamination 交叉污染 4.6 Temperature and relative humidity 温度和相对湿度 5. Dust control 固体颗粒污染物控制 6. Protection of the environment 环境保护 6.1 Dust in exhaust air 排气中的固体颗粒 6.2 Fume removal 烟尘的祛除 7. Systems and components 系统和构造 7.1 General 概论 7.2 Recirculation system 循环系统 7.3 Full fresh air systems 送风系统 8. Commissioning, qualification and maintenance 运转，资格和维护 8.1 Commissioning 运转 8.2 Qualification 资格 8.3 Maintenance 维护 References 文献 45 1. Introduction 介绍 Heating, ventilation and air-conditioning (HVAC) play an important role in ensuring the manufacture of quality pharmaceutical products. A well designed HVAC system will also provide comfortable conditions for operators. 加热，通风，空调（HVAC）系统在保证药品质量的生产上起着至关重要的作用。同时，设计完善的系统也会给操作人员提供舒适的工作环境。 These guidelines mainly focus on recommendations for systems for manufacturers of solid dosage forms. The guidelines also refer to other systems or components which are not relevant to solid dosage form manufacturing plants, but which may assist in providing a comparison between the requirements for solid dosage-form plants and other systems. 这些条例主要是针对固体药剂生产车间而提出的。但同时在涉及到与固体药剂生产无关的其它生产中，这些条例可以比较固体药剂生产车间和其它车间生产规格上的具体要求。 HVAC system design infl uences architectural layouts with regard to items such as airlock positions, doorways and lobbies. The architectural components have an effect on room pressure differential cascades and cross-contamination control. HVAC系统的设计与建筑规划有关，比如气阀、门口、出入口。这些物件的设计对房间气压差的形成和交叉污染的控制都起着重要作用。 The prevention of contamination and cross-contamination is an essential design consideration of the HVAC system. 污染和交叉污染的防制是HVAC系统设计的重点考虑因素。 In view of these critical aspects, the design of the HVAC system should be considered at the concept design stage of a pharmaceutical manufacturing plant. 鉴于这些关键点，在药品生产车间的设计阶段，HVAC系统的设计规划就应被考虑进去。 Temperature, relative humidity and ventilation should be appropriate and should not adversely affect the quality of pharmaceutical products during their manufacture and storage, or the accurate functioning of equipment. 适当的温度、相对湿度和良好的通风条件无论是在药品的生产和储藏阶段，都会影响药品质量。 This document aims to give guidance to pharmaceutical manufacturers and inspectors of pharmaceutical manufacturing facilities on the design, installation, qualification and maintenance of the HVAC systems. 本文献的目的是给药品生产和质检人员提供便利，在HVAC系统的设计、设备安装、资质条件以及系统维护方面。 These guidelines are intended to complement those provided in Good manufacturing practices for pharmaceutical products (1) and should be read in conjunction with the parent guide. 这些条例也是（药品生产GMP）（1）的补充说明，在总条例的中也会读到。 The additional standards addressed by the present guidelines should therefore be considered supplementary to the general requirements set out in the parent guide. 现在这些增加的标准也应考虑作为制定总条例的重要补充部分。 2. Scope of document 文献范围 These guidelines focus primarily on the design and good manufacturing practices (GMP) requirements for HVAC systems for facilities for the manufacture of solid dosage forms. Most of the system design principles for facilities manufacturing solid dosage forms also apply to other facilities such as those manufacturing liquids, creams and ointments. These guidelines do not cover requirements for manufacturing sites for the production of sterile pharmaceutical products. 这些条例主要是便利固体药剂生产的设计和HVAC系统GMP生产要求。大多数系统的设计原理是为固体药剂生产提供便利，同时也给液体、悬浮剂、膏剂提供便利。这些条理不仅仅是中间体药物生产的规范，同时也是GMP检查者的基本指导条目。 These guidelines are intended as a basic guide for use by GMP inspectors. 这些条例并不能给具体生产和参数设计指导，说明性的意义。 They are not intended to be prescriptive in specifying requirements and design parameters. There are many parameters affecting a clean area condition and it is, therefore, difficult to lay down(制定) the specific requirements for one particular parameter in isolation. 各种不同的参数才能影响一个环境，因此，很难在仅有一个参数的条件下制定出具体的生产要求。 46 Many manufacturers have their own engineering design and qualifi cation standards and requirements may vary from one manufacturer to the next. 不同的药品生产都有它们自己的工艺设计、质量标准以及产品要求。 Design parameters should, therefore, be set realistically for each project, with a view to creating a cost-effective design, yet still complying with all regulatory standards and ensuring that product quality and safety are not compromised. 在符合调整标准、能够保证药品生产质量和安全的情况下，为创造出最有效的生产环境，参数的设计因针对不同药品而有所不同。 The three primary aspects addressed in this manual are the roles that the HVAC system plays in product protection, personnel protection and environmental protection (Fig. 1). 这本指南上，HVAC系统在药品保护、人员保护以及环境保护这三个主要方面起着重要作用。 Figure 1 图1 The guidelines address the various system