Chromatographic Methods Validation SOP Example-Template

This SOP Example–Template is intended to provide general guidelines for the validation of chromatographic methods for the analysis of drug substance and drug product. The procedure is also applicable to fields outside the pharmaceutical industry in that it is based on sound scientific principals and broadly recognized practices. The Example-Template is primarily intended for use in validating High Performance Liquid Chromatographic (HPLC) methods but is applicable, with modification, to other chromatographic techniques. This SOP Example – Template is a modifiable 102 page Microsoft® Word document. This product is available for download.