A colleague and I were recently sharing QA ‘war stories.’ She was relating to me her encounter with a, ‘But why?’ person in the GCP operations world. These are the folks who demand you point to ‘the specific regulation that says we have to have SOPs.’ After many years working in clinical research and development, there is nothing I would like more than GCP regulations that provide as many clear-cut requirements as GLP and GMP regulations seem to do. But alas, wishing has not