> Process Validation
Analytical Methods
When required, the analytical methods used to test pharmaceutical finished products are validated.
A validation protocol is written prior to the actual validation. This document outlines the studies that will be performed during method validation and specifies the acceptance criteria for each of these studies, where applicable.
Once the required studies have been performed, a validation report is written. This document presents and discusses the results of the various studies. Raw data (e.g. chromatograms, method print-outs, injection sequences, etc.) are included in the report.