仿制药一致性评价及其评价过程的质量管理-中国现代应用药学.PDFVIP

·药事管理 · 仿制药一致性评价及其评价过程的质量管理  * 秦 ，梁毅 (中国药科大学国际医药商学院，南京 211198) 垚 摘要：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。 关键词：仿制药；一致性评价；质量管理；PDCA 循环；QbD；cGMP 中图分类号：R926 文献标志码：A 文章编号：1007-7693(2017)04-0609-04 DOI: 10.13748/ki.issn1007-7693.2017.04.030 Consistency Evaluation and Quality Management in the Evaluation Process for Generic Drugs * QIN Yao, LIANG Yi (School of International Pharmaceutical Business, China Pharmaceutical University, Nanjing 211198, China) 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 consisten