WHO961文件-6无菌药品良好生产规范(中英文).doc

? World Health Organization WHO Technical Report Series, No. 961, 2011 WHO技术报告丛书961，2011 Annex 6 WHO good manufacturing practices for sterile pharmaceutical products 附件6 无菌规范 Introduction Following implementation of these WHO good manufacturing practices (GMP) guidelines (1) within the context of the WHO Prequali?cation of Medicines Programme, clarifying, editorial modi?cations have been proposed. These changes were adopted for maintenance purposes. In order to ease reading the full guideline has been reproduced again as an Annex to the current report of the WHO Expert Committee on Speci?cations for Pharmaceutical Preparations. 引言 以下WHO药品质量管理规范（GMP）（1）指南在WHO预审药物设计、阐明、编辑修改中已经被提出。这些变更的应用维护的目的。为了便于阅读整篇指南重新编制作为WHO药品标准专家委员会报告的一个附件。WHO good manufacturing practices for sterile pharmaceutical products WHO无菌规范 1. General considerations 3 1 总则 3 2. Quality control 3 2 质量控制 3 3. Sanitation 4 3卫生 4 4. Manufacture of sterile preparations 5 4 无菌产品的生产 5 5. Sterilization 19 5.灭菌 19 6. Terminal sterilization 20 6. 最终灭菌 20 7. Aseptic processing and sterilization by ?ltration 24 7. 无菌操作和过滤灭菌 24 8. Isolator technology 26 8. 隔离技术 26 9. Blow/?ll/seal technology 27 9. 吹/灌/封技术 27 10. Personnel 28 10. 人员 28 11. Premises 30 11.厂房 30 12. Equipment 33 12. 设备 33 13. Finishing of sterile products 34 13. 无菌产品完成 34 1. General considerations 1 总则1.1 The production of sterile preparations should be carried out in clean areas, entry to which should be through airlocks for personnel and/or for equipment and materials. Clean areas should be maintained to an appropriate standard of cleanliness and supplied with air that has passed through ?lters of the required ef?ciency. 1.1 无菌的生产应在洁净区进行，人员和/或设备和物料进入洁净区应通过气闸室进入。洁净区应保持适当的洁净度标准提供经过有效的过滤的空气。 1.2 The various operations of component preparation (such as those involving containers and closures), product preparation, ?lling and sterilization should be carried out in separate areas within the clean area. These areas are classi?ed into four grades (see se