Method validation in analytical sciences: discussions on current practice and future challenges

Abstract

Eurachem held a workshop on method validation in analytical sciences in Gent, Belgium, on 9–10 May 2016. A summary of the working group discussions is provided here. The discussions covered a range of issues concerned with current practice and future challenges in method validation, i.e. setting requirements for a method to be validated; planning validation studies; validation of qualitative and semi-quantitative methods; validation of multi-parameter methods; determination of trueness/bias; assessment of working range; validation in microbiology; and method validation under flexible scope of accreditation. Delegates (129) from 24 different countries and from different backgrounds, e.g. from both public and private laboratories, laboratory associations, accreditation bodies and universities, attended the working groups, thus providing opportunities to collect a variety of views and experiences as well as to identify potential gaps in current guidance and regulations. While the practicalities of assessing method performance characteristics are generally well understood, the issue of setting requirements for those characteristics beforehand is less straightforward. Although a number of documents addressing the principles of method validation are available, guidance on dealing with more complex and ‘non-ideal’ situations, as well as examples of good practice, would be welcomed and greater harmonisation of approaches was deemed necessary. There remains a need for guidance on both the concepts that apply to ‘qualitative’ or ‘nominal’ test methods and on the practical implementation of validation studies in such cases.