Page 166 - 2013 ISPAM Mid-Year Mtg Book

3/11/2013
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 Stakeholders reach consensus on:
◦ Intended use
◦ Applicability
◦ Analytical technique
◦ Definitions
◦ Method performance requirements table
◦ System suitability
◦ Reference materials
◦ Validation guidance
◦ Maximum time‐to‐determination
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 Analytical range
 Limit of detection
 Limit of Quantitation
 Repeatability
 Recovery
 Reproducibility
All parameters
have a minimum
requirement set
by the Working
Group
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