| 陈超,张孟历,张景辰.化学合成原料药上市后生产变更评估思考[J].中国药事,2022,36(12):1337-1342 |
| 化学合成原料药上市后生产变更评估思考 |
| Thoughts on Post-approval Changes of Synthetic Drug Substances Assessment |
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| DOI：10.16153/j.1002-7777.2022.12.001 |
| 中文关键词: 原料药 药品上市后变更 变更评估 药品监管科学 |
| 英文关键词: API post-marketing drug change change assessment science of drug regulation |
| 基金项目:上海市药品监督管理局课题研究项目(编号 ZX-2022-08) |
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| 中文摘要: |
| 目的：为化学合成原料药上市后变更的评估提供思路。方法：通过美国和我国原料药监管要求、 原料药变更影响因素分析原料药变更评估中的关注点。结果：化学合成原料药生产工艺更具有特异性， 所以原料药上市后变更更需要结合品种特点，对变更的风险及研究验证工作进行全面的评估。结论：化学合成原料药变更需从品种特点、人员素质、设施设备、杂质情况、物理性质等五个主要方面进行全面的分析、研究和验证，从而确定变更对原料药和制剂产生的影响。 |
| 英文摘要: |
| Objective: To put forward some thoughts for the assessment of post-marketing change of chemical synthetic active pharmaceutical ingredients (API). Methods: The concerns on the evaluation of API change were analyzed through the regulatory requirements of API and the infl uencing factors of API change in the United States and China. Results: The production process of chemical synthetic API is specifi c, so it is necessary to combine the characteristics of the variety to make a comprehensive assessment of the risk of change and research validation. Conclusion: The change of chemical synthetic API requires comprehensive analysis, research and verifi cation from fi ve main aspects: variety characteristics, personnel quality, facility and equipment, impurities and physical properties, so as to determine the impact of the change on API and preparation. |
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