风险评估和基于风险的方法对使用前/消毒后完整性测试 (PUPSIT) 的评估
Kelly Waldron1, Amanda McFarland1, Hal Baseman1
1ValSource Inc, Downingtown, PA; and.
PDA journal of pharmaceutical science and technology
|March 3, 2025
概括
本文介绍了评估使用前/消毒后完整性测试 (PUPSIT) 风险和益处的框架. 它有助于评估欧盟附件1要求的替代方案,使用风险管理原则进行合规.
科学领域:
- 药品质量风险管理 药品质量风险管理
- 无菌产品制造业 无菌产品制造业
- 监管合规性 监管合规性
背景情况:
- 国际协调理事会 (ICH) Q9指南于2023年1月更新,加强了科学驱动战略的基于风险的决策指南.
- 监管要求仍然必须满足,即使在使用质量风险管理 (QRM) 作为决策支持.
- 欧盟 (欧盟) 附件1规定使用前/消毒后完整性测试 (PUPSIT),但承认某些过程的可行性限制,如小容量过.
研究的目的:
- 引入一个结构化的框架来评估与PUPSIT相关的风险和好处.
- 提供基于科学和风险的方法来评估替代方法对欧盟附件1 PUPSIT 要求的可接受性.
- 确保有关PUPSIT替代品的决策是明智的,平衡的,并符合监管期望.
主要方法:
- 开发一个专门为PUPSIT评估量身定制的风险管理框架.
- 考虑三个关键领域:患者安全,过程完整性和监管合规性.
- 应用风险评估原则,以确定当PUPSIT不可行时,替代控制的适用性.
主要成果:
- 拟议的框架允许系统评估与PUPSIT相关的风险和好处.
- 它有助于评估可替代策略,以满足欧盟附件1要求,当PUPSIT提出挑战.
- 该框架通过平衡运营现实,患者安全和法规遵守来支持知情决策.
结论:
- 组织可以使用基于科学和风险的方法有效地导航PUPSIT要求.
- 该框架允许遵守监管期望,同时解决无菌过工艺的实际限制.
- 实施这种方法可以确保对非整体过系统的强有力的风险减轻.
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