Module 23

Process requirements Process requirements –

Method selection, verification and validation
(continued)

Clause 7 (part 3)

Presenter: Tim Alcock

www.Qualimetric.co.uk
 7.2 Method validation
• Validate:
– Non-standard and laboratory developed methods
– Those outside their intended scope/modified
 7.2 Method validation
• Validation by:
– Bias and precision via reference materials/standards
– Systematic assessment or uncertainty analysis
– Robustness through variation of controls
– Comparison with other validated methods
– Interlaboratory comparison
– Evaluation of uncertainty of results vs theoretical principles/practical
experience
 7.2 Method validation
• Changes to validated methods
• Impact?
– Equipment
– Reference materials
– Method update
– Training and competency…..
 7.2 Method validation
• Performance meets customer needs/requirements
• Records of: PERFORMANCE CHARACTERISTICS: measurement range, accuracy, measurement
– Validation procedure uncertainty of the results, limit of detection and quantification, selectivity of the
– Requirements specification method, linearity, repeatability or reproducibility, robustness against external
influences or cross-sensitivity against interference from the matrix of the sample or
– Performance characteristics test object, bias.
– Results
– Statement on method validity regarding fitness for use
 7.2 Method validation
• Guidance documents on method validation:
– Chemistry: Eurachem www.eurachem.org
– Pharmaceutical: www.ema.europa.eu/
– ISO 5725 (parts 1-6) Accuracy (trueness and precision) of measurement methods and results
– Public Health England – UK Standards for Microbiology Investigations – Evaluations,
validations and verifications of diagnostic tests www.gov.uk