分析测量的应用 药品材料质量控制策略的不确定性和考虑
Michael A Zompa1, Dolee Merai1, Paul Oram1
1Analytical Research and Development, MRL, Merck & Co., Inc., Rahway, New Jersey 07065, United States.
Analytical chemistry
|December 29, 2025
概括
本研究提出了一种方法,以设定药品测试的接受限值,考虑到测量不确定性. 这种方法提高了对材料质量的信心,并支持综合控制策略.
科学领域:
- 制药科学 制药科学
- 分析化学 分析化学
- 质量控制 质量控制 质量控制
背景情况:
- 国际协调委员会 (ICH) Q14和美国药典 (USP) <1220>提供了关于测量不确定性的指导.
- 测量不确定性对药物材料评估的决策产生重大影响.
- 现有的方法可能无法完全将不确定性纳入接受标准.
研究的目的:
- 展示一种方法来设定包含分析测量不确定性的接受限值.
- 为制药原料制定综合控制战略.
- 通过意识到不确定性的决策,加强对药品原料质量的信心.
主要方法:
- 利用案例研究来说明拟议的方法.
- 制定了一个框架,以考虑测量不确定性来设定验收限制.
- 将不确定性意识限制纳入更广泛的控制战略.
主要成果:
- 在案例研究中成功证明了该方法的应用.
- 展示了如何在接受限度中适应分析测量不确定性.
- 建立了不确定性管理和增强材料质量信心之间的明确联系.
结论:
- 拟议的方法有效地将分析测量不确定性纳入接受度限制设置.
- 实施这种方法可以加强制药原料的整体控制策略.
- 这种方法为改善决策和确保药品质量提供了一个强大的框架.
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