| 沈启雯,梁毅.从质量管理角度看药品的一致性评价[J].中国药事,2017,(11):1229-1232 |
| 从质量管理角度看药品的一致性评价 |
| Consistency Evaluation of Drugs from the Perspective of Quality Management |
| 投稿时间：2017-08-26 |
| DOI：10.16153/j.1002-7777.2017.11.001 |
| 中文关键词: 一致性评价 仿制药 质量管理 药品生产质量管理规范 |
| 英文关键词: consistency evaluation generic drug quality management good manufacturing practice |
| 基金项目:江苏省教育厅人文社科基金（编号2013SJD630129） |
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| 中文摘要: |
| 目的：探讨实施药品质量一致性评价工作的方法，使一致性评价真正发挥提高仿制药质量水平的作用。方法：基于质量管理的核心理念，从仿制药的原辅料、处方、工艺流程、最终产品和生产线5个方面入手，实现仿制药与原研药过程控制的一致性。结果：我国要全面提高仿制药的质量，开展仿制药与原研药的一致性评价，这对于保障药品安全、有效、质量可控有着十分重要的意义。结论：药品的安全性和有效性一直是公众关注的热点问题。仅通过溶出度试验来判断仿制药的安全有效存在一定的局限性，应当将GMP理念引入一致性评价工作中，全方位地保证仿制药与原研药具有相同的安全性和有效性。 |
| 英文摘要: |
| Objective: To explore the method to implement the consistency evaluation of drugs to make sure that the consistency evaluation really plays the role of improving the quality of generic drugs. Methods: Based on the core concept of quality management, fve aspects of generic drugs including raw materials, producing prescription, technological process, fnal products, and the production line were analyzed to achieve consistency of process control between generic drugs and original drugs. Results: China should comprehensively improve the quality of generic drugs and carry out the consistency evaluation of generic drugs, which is very important for ensuring the safety, effectiveness and controlled quality of drugs. Conclusion: The safety and effectiveness of drugs have always been a hot issue of public concern. It is not reliable to judge whether the generic drugs are safe or effective only by the dissolution test. GMP concept should be introduced into the consistency evaluation in order to fully guarantee that generic drugs have the same safety and effectiveness as original drugs. |
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