TRS957_2010 含毒质药品WHO生产管理规范.docVIP

Annex 3 WHO good manufacturing practices for pharmaceutical products containing hazardous substances 附录3 含毒质药品WHO生产管理规范1. Introduction 2. General 3. Glossary 4. Risk assessment 5. Product protection 6. Personal protection equipment and breathing air systems 7. Environmental protection 8. Facility layout 9. Air-handling systems 10. Air-handling units 11. Safe change fi lter housings 12. Personnel decontamination systems 13. Effl uent treatment 14. Maintenance 15. Qualifi cation and validation 介绍 总则 索引 风险评估 产品安全 个人防护设备和空气系统 环境保护 厂房布局 空气处理系统 空气处理单元 安全变更过滤罩 人员防污染系统 废物处理 维护 认证和验证 References 193 1. Introduction 1.1 These guidelines set out good practices applicable to facilities handling pharmaceutical products (including active pharmaceutical ingredients (APIs)) that contain hazardous substances such as certain hormones, steroids or cytotoxins. They do not replace national legislation for protection of the environment and personnel. Other WHO guides to good manufacturing practices (GMP) and regulations need to be observed in addition to the workers’ safety criteria (1–4). 1.2 These guidelines are to be read in conjunction with other WHO GMP guidelines with respect to building fi nishes and general services installations, among others. See the reference list for relevant publications which serve as additional background material. The primary focus of these guidelines is on the air-conditioning and ventilation systems of the facility; however, the document also provides some guidance on personnel protection. 1.3 The areas to which this document applies include all zones where the handling of products could lead to cross-contamination, exposure of personnel, or discharge to the environment. This includes research and development facilities, and the sites of API manufacturing and storage and of fi nished product manufacturing. 1.4 Where possible products should be manufactured in closed systems. 2. General 2.1 Facilities should be designed and operated in accordance with the