Top 10 Most-Cited MHRA GMP Inspection Deficiencies By Annex/Chapter In 2019
We evaluated the U.K. Medicines and Healthcare products Regulatory Agency’s (MHRA) GMP inspection data for 2019, including trends associated with prior years, in Part 1 of this two-part article. We also addressed the critical and major deficiencies and the annexes and chapters with which they are associated. In this part, we take the 10 chapters and annexes with the highest numbers of deficiencies and do a deeper dive into the specifics of each.
In the figures that follow, we identify the paragraphs that were cited most frequently for each of the 10 chapters and annexes identified in Figure 1 of part 1 of this series. For two of these, Chapter 1 and Annex 15, we provide two figures for each because a handful of the paragraphs dominate the deficiencies in those areas. The following figures include