山东省化学药品上市许可持有人(试点)委托生产质量研究常见问题分析

Problem Analysis of Chemical Drug Quality Research of Entrusted Production under MAH System in Shandong Province

目的对山东省药品生产企业生产加工厂地异地搬迁或车间异地搬迁申报药品上市许可持有人(试点)委托生产化学药品质量研究中常见问题进行汇总,供相关申请人参考。方法结合审评经验和相关文件要求,对持有人委托生产化学药品质量研究中常见问题进行汇总分析。结果持有人委托生产化学药品质量研究中质量标准对比、方法学验证、质量对比和杂质谱对比等方面仍存在问题。结论建议通过完善的质量研究保证药品质量,保证委托生产前后产品质量的一致性。

Objective To summarize the common problems found in quality research in application of entrusted production of chemical drugs by pharmaceutical enterprises in Shandong Province because of relocation of manufacturing site or workshop of Marketing Authorization Holder(MAH), to provide reference for relevant applicants. Methods Combined with the review experience and the requirements of relevant documents, the common problems in the quality research in entrusted production of chemical drugs by MAH were summarized and analyzed. Results There were many problems in quality research, such as the comparasion of quality standard, method validation, quality comparison, comparative study on the impurities and so on. Conclusion It is proposed that the drug quality should be guaranteed through perfect quality research, and the consistency of product quality before and after entrusted production should be ensured.