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Application of Analytical Measurement Uncertainty and Considerations toward Pharmaceutical Material Quality Control
Michael A Zompa1, Dolee Merai1, Paul Oram1
1Analytical Research and Development, MRL, Merck & Co., Inc., Rahway, New Jersey 07065, 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.
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