科学和基于风险的稳定性策略,以支持产品生命周期变化
Lori McCaig1, Steven Nowak2, Alexander Abbott3
1Pfizer Inc, 21823 30Th Drive SE, Bothell, Washington, 98021, USA.
The AAPS journal
|March 15, 2024
概括
本研究表明,在批准后的变化 (PAC) 中使用科学和基于风险的方法进行稳定性研究. 利用先前的知识可以实现自信的变化管理,并可能减少稳定性数据要求.
科学领域:
- 制药科学 制药科学
- 监管科学 监管科学
背景情况:
- ICH Q12指南支持科学和基于风险的方法,用于化学,制造和控制 (CMC) 的批准后变化 (PAC).
- 缺乏具体的例子阻碍了在对CMC PAC的风险评估中应用先前知识.
研究的目的:
- 证明CMC PAC的科学和基于风险的稳定性策略的应用.
- 为了说明事先的知识如何为产品生命周期管理的风险评估提供信息.
主要方法:
- 介绍了十个涉及毒品物质和产品CMC PAC的不同案例研究.
- 利用原始制造商积累的稳定性知识来评估变化影响.
主要成果:
- 通过科学和基于风险的稳定性策略,成功支持药物物质和产品CMC PAC.
- 通过利用先前的知识,证明有效的风险评估和自信的变革管理.
结论:
- 科学和基于风险的稳定性策略对于CMC PAC和生命周期管理是有效的.
- 利用先前的知识可以导致减少稳定性数据承诺和PAC的报告类别.
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