Application of Analytical Measurement Uncertainty and Considerations toward Pharmaceutical Material Quality Control Strategies

20250 citationsJournal Article

Authors

Michael A. Zompa · Merck & Co., Inc., Rahway, NJ, USA (United States)

Dolee Merai · Merck & Co., Inc., Rahway, NJ, USA (United States)

Paul Oram · Merck & Co., Inc., Rahway, NJ, USA (United States)

David Lavrich · Merck & Co., Inc., Rahway, NJ, USA (United States)

J. David Christopher · Merck & Co., Inc., Rahway, NJ, USA (United States)

Jorge Quiroz · Merck & Co., Inc., Rahway, NJ, USA (United States)

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.

Topics & Keywords

Pesticide Residue Analysis and Safety Scientific Measurement and Uncertainty Evaluation Analytical Methods in Pharmaceuticals

Publication Details

Published in: Analytical Chemistry

Volume 98, Issue 1, pp. 989-995

DOI: 10.1021/acs.analchem.5c06322

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Application of Analytical Measurement Uncertainty and Considerations toward Pharmaceutical Material Quality Control Strategies

Authors

Abstract

Topics & Keywords

Publication Details