文档介绍：《药品生产质量管理规范(2010 年修订)》
《Good Manufacturing Practice (2010 revision) 》
Annex1 to Annex5 Technical Reviewed by ISPE
Michael Lee, Zhao Chunhua
Zhao Yunxia, He Guoling, Ji Yiyun
Initial Translation from NNE Pharmaplan
1
Chinese GMP revised in 2010
附录1:
Annex 1:
无菌药品
Sterile Medicinal Products
目录
Table of Contents
第一章范围..................................................................................................... 4
Chapter 1 Scope ............................................................................................... 4
第二章原则..................................................................................................... 4
Chapter 2 Principle............................................................................................ 4
第三章洁净度级别及监测............................................................................... 5
Chapter 3 Cleanliness classification and monitoring ........................................ 5
第四章隔离操作技术.................................................................................... 15
Chapter 4 Isolator technology ......................................................................... 15
第五章吹灌封技术........................................................................................ 16
Chapter 5 Blow/fill/seal technology ................................................................. 16
第六章人员................................................................................................... 17
Chapter 6 Personnel ....................................................................................... 17
第七章厂房..........................................................................................……..19
Chapter 7 Premises......................................................................................... 19
第八章设备................................................................................................... 21