仿制药一致性评价及其评价过程的质量管理

目的 探讨仿制药一致性评价过程的质量管理，为中国制药企业高效开展一致性评价工作提供参考。方法 阐述一致性评价的基本概念，对仿制药一致性评价的发展阶段和关键步骤进行梳理，提出PDCA循环管理模式在一致性评价过程中的应用。结果 运用PDCA循环管理模式对评价过程进行全面质量管理，可以制定出一致性评价的科学程序。QbD设计管理理念和cGMP生产管理理念的应用，可以保证产品从研发到生产全过程的一致性。结论 以QbD和cGMP理念为重点的PDCA循环管理模式可在中国制药企业一致性评价过程中加以应用，从而加强仿制药一致性评价过程的质量管理。

Consistency Evaluation and Quality Management in the Evaluation Process for Generic Drugs

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.