The Fitness for Purpose of Analytical Methods (1998)
The Fitness for Purpose of Analytical Methods: A Laboratory Guide to Method Validation and Related Topics (1998)
This guide was produced by a correspondence group comprising mainly Eurachem members. 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 within-laboratory method validation. Related issues are also dealt with: use of validated methods; designing quality control from validation 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.
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