Abstract
Objective To establish design qualification (DQ) documents of biological product premises conforming to Good Manufacturing Practice (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. Key words: Design qualification; Good manufacture practice; Biological products
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