WHO Supplementary Training Modules: Validation, Water, Air Handling Systems - Validation (Part 3): Cleaning Validation: Validation

WHO Supplementary Training Modules: Validation, Water, Air Handling Systems - Validation (Part 3): Cleaning Validation
(2006; 43 pages)

Table of Contents

Validation

Analytical methods (2)

Validation of the analytical method should include, e.g.

- precision, linearity and selectivity (the latter if specific analytes are targeted);

- limit of detection (LOD);

- limit of quantitation (LOQ);

- recovery, by spiking with the analyte; and

- reproducibility
Detection limit (sufficiently sensitive) to detect the established acceptable level of residue / contaminants

10.3 Validation of the analytical method should include as appropriate:

- precision, linearity and selectivity (the latter if specific analytes are targeted);

- limit of detection (LOD);

- limit of quantitation (LOQ);

- recovery, by spiking with the analyte; and

- reproducibility.

10.4 The detection limit for each analytical method should be sufficiently sensitive to detect the established acceptable level of the residue or contaminants.