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医薬品材料品質管理戦略に向けた分析測定不確かさの適用と考察

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

Abstract:

Guidance documents ICH Q14 and USP <1220> discuss the uncertainty associated with measurements and its impact on decisions regarding pharmaceutical materials. Through case studies, we demonstrate an approach for setting acceptance limits for analytical test results accommodating analytical measurement uncertainty, establishing an integrated control strategy, and reinforcing confidence around material quality.

キーワード:

測定不確かさ許容限界医薬品品質管理分析化学製薬科学

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