The Fitness for Purpose of Analytical Methods: A Laboratory Guide to Method Validation and Related Topics

The Fitness for Purpose of Analytical Methods: A Laboratory Guide to Method Validation and Related Topics
Contents: This guide, produced by a correspondence group, comprising mainly Eurachem members is based on an earlier LGC-produced draft. A number of papers have been published promoting validation at a policy level. Others give guidance on validation for particular applications and the use of interlaboratory trials. The Eurachem guide aims to fill the gap in between by providing guidance on the various elements of validation (when methods should be validated, who carries out the validation, how methods should be validated, use of blanks, standards and replication) and is directed primarily towards laboratories working in isolation. Related issues are also dealt with: use of validated methods; designing quality control from valid-ation data; implications of validation data for reporting; and documentation of methods. The guide contains an extensive bibliography including sector specific guidance and annexes list officially recognised definitions and a protocol for method documentation. After successfully collaborating to produce guidance notes for chemical laboratories seeking accreditation to EN 45001, Eurachem and EA identified microbiology as being another area requiring similar attention.
Availability: English language versions (edition 1.0 1998) are available from VAM. Alternatively, you may download the guide from this website (pdf, 236 kB). Translations: the guide has been translated into Czech, Japanese, Lithuanian, Polish and Spanish. For details please contact the Eurachem representative in the respective country or the Eurachem Secretariat.