Where do you draw the line? Points to consider when implementing the FDA method validation guidance on quantifying chromatographic peaks

Summary

The advent of automated/computerised data collection and processing systems has minimised the amount of manual intervention and human decision-making required to determine the baseline for a chromatographic peak. There remain however, a number of activities, fundamental to the accuracy of chromatography, still requiring visual checking and evaluation. The regulatory agencies, particularly the FDA, recognise the need for data integrity in this process and have suggested a way forward in their Bioanalytical Method Validation Guidance. A progmatic approach is proposed which, while maintaining a high degree of objectivity and transparency, nevertheless allows for sample variability that cannot be predicted or categorised.