Measurement Uncertainty and Conformity Assessment Applied to Drug and Medicine Analyses – A Review

Abstract

Analytical results are often used in scientific research, industrial and clinical applications to support decision making. Despite all efforts to ensure the reliability of analytical results (including method validation, internal quality control, use of certified reference materials, proficiency tests, and ISO 17025 accreditation), there will always be an uncertainty associated with the measured value. The measurement uncertainty expresses the quality of the analytical result and allows the comparability between analytical results or between the measured value and the specification limit(s). This work discusses the importance of measurement uncertainty, including the steps involved in the measurement uncertainty evaluation, the bottom-up and top-down approaches used in measurement uncertainty calculation, the measurement uncertainty evaluation in drug and medicine analyses, and the application of measurement uncertainty in conformity assessment for quality control, stability studies, and pharmaceutical equivalence.

Keywords:

• Analytical procedures
• conformity assessment
• measurement uncertainty
• method validation
• pharmaceutical products

Additional information

Funding

This work was supported by FAPESP – Fundação de Amparo à Pesquisa do Estado de São Paulo (Brazil) (2019/16206-3, 2019/15549-4, and 2018/25734-0).