If a film were made on GMP inspections, it could be titled GMP Inspections Feel like Groundhog Day. It is sometimes almost astonishing how often companies "commit" similar or even the same mistakes — in (almost) always the same places. Some countries, e.g., the U.K. and Brazil, publish deficiency statistics at irregular intervals, e.g., MHRA GMP Deficiency Data 20191 or Quality of medicines: Deficiencies found by Brazilian Health Regulatory Agency (ANVISA) on good manufacturing practices international inspections.2

But what do such statistics actually say? Do they really reflect the areas where companies are making the most or most serious mistakes, as indicated in the MHRA introduction? Or do they perhaps rather reflect the priorities of the respective authorities? Or perhaps also the most recent regulatory changes?...[Bioprocess]