目的  研究建立符合《药品生产质量管理规范（2010年修订）》要求的生物制品生产厂房的设计确认（design qualification，DQ）文件。 方法   将生产厂房的DQ文件分为DQ方案和DQ报告。对工艺布局、生产厂房、净化空调系统、洁净暖房、洁净冷库DQ进行探讨。 结果   通过设计与确认，以文件和记录证明生物制品厂房的设计符合预定用途和药品生产质量管理规范。 结论   建立了符合药品生产质量管理规范的生物制品生产厂房的设计确认文件，为生产安全有效的生物制品奠定了基础。

Objective  To establish design qualification (DQ) documents of biological product premises conforming to Good Manufacturing Practice for Drugs (GMP) (2010 Revision).  Methods   DQ documents were divided into two parts: protocol and report. The DQs of process layout, manufacturing premises, heating, ventilation and air conditioning systems, clean warm room and clean cold room were discussed.  Results   Through design and qualification, the premises design was proven to comply with the intended use and GMP regulations by documents and records.  Conclusion   The DQ documents of biological product manufacturing premises meeting GMP requirements is established, which lays the foundation for production of safe and effective biological products.