ANALYTICAL METHOD VALIDATION SOP AND TEMPLATE

A complete template that includes an SOP for how to perform a method validation as well as a method validation report template. Click on the product name for more detail.  In MS-WORD format.

This working template covers all aspects of analytical method validation such as linearity and range, accuracy and recovery, limit of detection, limit of quantitation, assay and injection precision, intermediate precision, robustness and stability indication by forced degradation studies.The fill in the blank report template makes short work of complicated method validation reports, and can be used as-is or with modification to suit individual needs. The template is in line with USP and ICH guidelines but offers much more how to do it detail than any standard reference book.

CALIBRATION/QUALIFICATION OF HPLC SYSTEMS

A complete component by component procedure for calibration/qualification of HPLC systems. In MS-WORD format.

 Detailed calibration/qualification procedure for HPLC systems. Includes detailed procedures for solvent delivery systems, variable wavelength and photdiode array UV detectors, autosamplers (including chilled and heated autosamplers) and column ovens.  Can be used as part of  an IQ/OQ/PQ program or as a procedure for routine calibration of HPLC systems as part of ongoing cGMP compliance. Includes wavelength accuracy check procedures for both variable wavelength UV detectors as well as for photo diode array UV detectors.