Abstract: OBJECTIVE To discuss the quality management in the consistency evaluation for generic drugs and provide a reference for pharmaceutical companies in China to carry out the consistency evaluation efficiently.METHODS The basic concepts of consistency evaluation was explained, then the development stage and critical steps of consistency evaluation in China was reviewed. Finally put forward the application of PDCA cycle in the evaluation process. RESULTS Using the PDCA cycle management model to conduct comprehensive quality management could develop a scientific procedure for the consistency evaluation. Application of QbD (design management concept) and cGMP (production management concept) could ensure the consistency of the whole process of products from development to production. CONCLUSION The PDCA cycle management model, with QbD and cGMP concepts as the focus, can be applied in the consistency evaluation of pharmaceutical enterprise in China to strengthen the quality management in the consistency evaluation for generic drugs.