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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
An Analysis Of MHRA s Latest Annual GMP Inspection Deficiencies Report
The U.K.’s Medicines and Healthcare products Regulatory Agency (
MHRA) has taken a different approach in the publication of the
GMP deficiencies for drug product issued during inspections in 2018 and 2019. In 2015 and 2016, the MHRA provided approximately a 100-slide deck each year with tables, figures, and text from deficiencies against the requirements in the chapters and annexes. No data were formally published for 2017. The MHRA published a 6,200-plus line Excel spreadsheet of its 2018 GMP inspection data so that individuals could parse and present the data according to their needs. Last year we published analysis of the data in a two-part set of articles: “An Analysis Of MHRA s Annual GMP Inspection Deficiencies Report” and “The 10 Most-Cited MHRA GMP Inspection Deficiencies By Annex/Chapter.”