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In Part 1 of this two-part article, we evaluated the U.K. Medicines and Healthcare products Regulatory Agency’s GMP inspection data for 2019...
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 ...