（好文推荐）基于科学和风险概念在原料药稳定研究策略中的应用

beiwei5du

附件：The Applicationof Science-and Risk-Based Concepts to Drug Substance Stability Strategies

1、注册中必须遵循ICH Q1A的稳定性数据要求吗，如何找到一种更有效合理的方式（Q1A中所提及到的alternative approaches）？？？（包括稳定性研究批次和检测时间点等等）
2、变更就必须要做正式和非正式的稳定性研究吗？？？
3、变更后是否进行稳定性研究，以及稳定性研究的程度？？？
4、常规生产中必须每年有至少留一批做持续稳定性考察吗？？？？
5、稳定性研究中检测项目如何选择？？？

In this paper, proposals are presented to more fully leverage enhanced product knowledge to design improved stability strategies. The chemical and
physical attributes that potentially impact drug substance stability are discussed, and strategies that leverage accelerated stability studies are presented.

There are potential benefits for the pharmaceutical industry, global regulators, and patients that could be realized by adapting scientific stability strategies that leverage understanding of these chemical and physical attributes which can impact drug substance stability. Consistent with the Q8 and Q11 principles,
a fundamental understanding of stability, coupled with risk-based  and prospective control strategies, could reduce the overall number and/or type of stability studies (regulatory flexibility), while increasing confidence in the proposed drug substance storage retest periods.

The practice of evaluating process changes with short accelerated studies also can minimize the number of “ low value” traditional long-term stability programs either for batches with equivalent stability o r unacceptable stability p erformance.
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