AOAC SPIFAN Stakeholder Panel Meeting Book (March 12, 2020)
2. Analytical method variability SPIFAN methods
• Mean RSD R values calculated from MLT for matrices within ±25% of midpoint regulatory requirements. Degrees of freedom for each matrix taken into account to calculate SD R . • All RSD R 7 3. Definition of Method Capability ( C m ) = 6 × SD C p =1: 0.27% of products out of specification (99% CI) = 6 × SD • SD < SD • Variance analytical method considered 1/3 of process variance • = × = 1.73 • <1.73 problem to achieve =1, <1 critical 8
Made with FlippingBook Annual report