Traceability without uncertainty current situation in pharmaceutical industry

Traceability without uncertainty current situation in the pharmaceutical industry 

Abstract The current situation in the pharmaceutical industry is discussed, when the traceability of measurement (analytical) results to certified values of pharmacopoeial reference standards is required, without evaluating their uncertainties. It is shown that the evaluation of measurement uncertainty is necessary for understanding the level of confidence of the analytical results and their comparability, particularly during preparation and characterisation of the reference standards. 

Keywords Traceability Measurement uncertainty Reference materials Quality of analytical results 

Comparable analytical results are required in the pharmaceutical industry, not only to avoid duplication measurements, which cost time and money, but also to be sure that the product corresponds to its specifications and is not harmful or even dangerous for a patient. Comparable results obtained in different laboratories at different time can be achieved only if these results are anchored to a common base, i.e. are traceable to this common base, preferably to one widely recognized worldwide [1], Establishment of traceabilty for an analytical method is based on understanding that  

While developing the method, a set of measurement conditions, procedure and a formula for the analyte calculation are optimised, 

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