Planning and Reporting Method Validation Studies

A Supplement to the Eurachem Guide "The Fitness for Purpose of
Analytical Methods"

Contents

Cover of mehod validation 'Planning' supplementPlanning is an essential stage in the validation process. Before starting any experimental work, the aim should be to have a clear plan for the entire validation study. This should cover the performance characteristics that will be studied, the target value for each performance characteristic, the materials that will be analysed, the level of replication and order of the experiments, any statistical analysis that will be used, and how the method will be judged as being fit for purpose.

This supplement provides guidance on the planning and reporting of validation studies. The document is structured in the form of a template which can be used to assist with planning the evaluation of the chosen performance characteristics. The template is structured such that once the experimental work has been completed, the document can be easily converted into a validation report. The supplement also contains a checklist to assist with validation planning.

This supplement is intended to be used in conjunction with "The Fitness for Purpose of Analytical Methods - A Laboratory Guide to Method Validation and Related Topics (2nd ed.)"

Availability

This supplementary guidance is available in the following languages:

Citation

This publication should be cited* as:
“V. Barwick (ed.), Planning and Reporting Method Validation Studies – Supplement to Eurachem Guide on the Fitness for Purpose of Analytical Methods (2019). Available from http://www.eurachem.org"

*Subject to journal requirements

Translations

Translation into other languages is permitted for members of Eurachem.