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E.NOVAL AND SEELVA ALLOW TO ACHIEVE UPCOMING USP RECOMMENDATIONS ON VALIDATION OF ANALYTICAL PROCEDURES

At the recent USP Workshop on Lifecycle Approach to Validation of Analytical Procedures with Related Statistical Tools held in Rockville (MD, USA) on December 8th-9th 2014, a new vision for the development, validation and control strategy of analytical procedures has been presented. This vision wisely adapt for analytical procedures the concepts described for processes in ICH Q8, Q9 and Q10, namely the Quality-by-Design and Risk-based management. This is described into a stimuli paper published by USP.

The Lifecycle Approach starts with the definition of ATP (Analytical Target Profile) that makes the quality attributes of each –future- reportable result the very objective of an analytical procedure and therefore the critical criteria to accept if an analytical method will be fit-for-purpose.  The accuracy and measurement uncertainty, over a range of concentration, proposed as critical quality attributes for deciding upon the validity of a procedure is already proposed and computed in e.noval and Seelva since the publications of the SFSTP related guidances in 2004. Indeed the proposed USP General Chapter <1210> Statistical Tools for Method Validation published in PF 40(5), that aims to become a statistical companion chapter for USP General Chapter <1225> largely makes references to the SFSTP approach using the Tolerance intervals as well as the Measure Uncertainty.

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March 17th, Paris

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WHERE TO FIND US NEXT

January 13: Quality-by-Design Course, Cambridge, UK

January 19–20: Chimiométrie XVI, Geneva, Switzerland

February 4–5: Quality by Design, Biopole, Ivry, France

March 8–12: PittCon 2015, New Orleans, USA

March 24–25: 3rd QbD Forum, Leicester, UK

March 30–31: Process Validation Summit, Philadelphia, USA

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