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PLContext:
A quality control specialist in a pharmaceutical company must calculate and document measurement uncertainty for an analytical method used to determine active substance content. The calculation must comply with the GUM methodology. The resulting measurement uncertainty may be included on Certificates of Analysis and/or used to support conformity decisions when results approach specification limits.
Determining uncertainty according to GUM requires advanced statistical methodology: identifying all relevant sources of uncertainty, classifying each source as Type A (statistical) or Type B (other information), calculating sensitivity coefficients (often using partial derivatives), combining uncertainties using the law of propagation, and determining the effective degrees of freedom using the Welch–Satterthwaite formula. Manual calculations can be time-consuming and error-prone.
Purpose:
The purpose of using the StatSoft MU application is to efficiently calculate measurement uncertainty for analytical methods using a verified, GUM-compliant statistical approach; to generate comprehensive uncertainty budgets identifying all significant sources; to create complete documentation; and to enable informed conformity assessments — all while minimizing QC workload and eliminating calculation errors.
Application:
A QC Specialist creates a new measurement uncertainty project in the StatSoft MU application by entering the analytical method description, definition of the measurand, sources of uncertainty (Type A or B), and the mathematical model linking the measurand to the input quantities. The application automatically builds the uncertainty budget, calculates the standard and expanded uncertainty, and provides a chart showing the contribution of each source.
StatSoft MU then generates a complete, professionally formatted report. The QC Analyst reviews the auto-generated report for completeness and scientific accuracy, adding method-specific interpretation, contextual information, or explanatory notes where needed.
Outcome:
Using StatSoft MU, the QC Specialist successfully generated a full uncertainty budget and determined the measurement uncertainty for an analytical method used to determine the active pharmaceutical ingredient (API).
Benefits
Time Efficiency Statistical measurement-uncertainty reports for analytical methods prepared in minutes rather than hours.
Compliance Comprehensive, GUM-compliant documentation of the measurement-uncertainty determination process.
Data-Driven Decisions Recommendations and conformity assessments supported by validated statistical methodology.
Consistency Standardized report formats, validated statistical methods, and harmonized templates.
Strategic Value Informed, risk-based decisions regarding the conformity of medicinal products to quality specifications.