The QMN Weekly Bulletin

Critical Findings in MHRA Inspections Increase for Second Straight Year

Jan. 29, 2016

During a one-year period, the UK’s Medicines & Healthcare products Regulatory Agency conducted 47 inspections of pharma companies, during which it found 27 critical, 169 major and 155 minor findings.

From April 1, 2014 to March 31, 2015, the MHRA inspected 25 innovative pharmaceutical companies, 20 generic drugmakers and two orphan, niche or herbal product makers.

Of the critical findings, 17 went to generics companies and 10 went to innovative drugmakers. The most cited critical finding was a lack of reference safety information, followed by signal management failures, oversight and quality system failures and risk management system lapses.

The agency reported a “sharp increase” in the number of critical findings associated with signal management. Seven critical findings were reported that were associated with failures to conduct signal detection activities, failures to incorporate all available data into signal detection activities, significant delays in completing signal evaluation and failures to address previously reported major inspection findings.

Less-cited critical findings included system failures, Periodic Safety Update Report production, individual case safety report management and submission of false and misleading information.

The 27 critical findings are up from 19 found during the April 2013 to March 2014 period. The year prior saw 18 critical findings.

Of the 169 major findings, signal management and individual safety case report management were the top two findings, followed by quality systems issues and reference safety information.

The MHRA said that 15 of the inspections were of marketing authorization holders that had not previously undergone an MHRA inspection. Twenty-one inspections were routine re-inspections and 10 inspections were trigged due to critical findings identified at previous inspections or in response to a specific issue.

To read the MHRA’s inspection report, go to www.fdanews.com/12-17-15-MHRAReport.pdf.

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