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FDAnews Drug Daily Bulletin

MHRA Finds Increasing Trend of Sterility Deficiencies

April 27, 2017

The U.K.’s Medicines and Healthcare products Regulatory Agency is finding more sterility assurance violations during facility inspections.

Sterility assurance citations increased in 2016 to become the second-most frequent category; they did not make the top 10 list for 2015, MHRA said, in a report tracking GMP findings over the past year.

The three most-cited categories were pharmaceutical quality system, sterility assurance and production-related GMP issues. For these three categories, across 324 site inspections last year, investigators identified 92 deficiencies labeled as critical and 830 as major, as well as 1,477 other issues.

MHRA performed 242 U.K. inspections in 2016, up from 224 the year before, and 82 overseas inspections compared to 79 in 2015.

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