MHRA Finds Increasing Trend of Sterility Deficiencies

April 28, 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.

The agency observed at least eight overdue corrective and preventive actions — ranging from 59 days to 242 days — that were closed just one day before the inspection. Meanwhile, 134 deviations were raised between November 2015 and February 2016, with no CAPA taken.

The most frequent pharmaceutical quality system issues — critical, major or otherwise — were related to EU GMPs for the manufacturing process, namely that managerial responsibilities were not clearly specified, necessary controls on intermediate products were not in place, and that appropriate levels of root cause analyses were not applied in investigations of deviations. Quality system deficiencies as a whole remained the top category from 2015 to 2016.

Regarding sterility assurance, the MHRA found spikes in the number of deficiencies related to the cleanliness of storage areas, as well as problems maintaining proper temperatures or humidity. Other examples included a facility providing no demarcation between clean and dirty sides of change rooms before entering formulation areas.

The agency also found several examples of insufficient protection against microbial contamination and cross-contamination, including a lack of written procedures for cleaning bays and methods, as well as several findings related to the fumigation of clean areas.

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