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Regulatory News

PDA's Regulatory News is a source of pertinent news from all over the globe. This section is set up by distinct parts of the world so you can read what is crucial to you and your company.

MHRA Publishes Inspection Data

Jul 5, 2017, 23:12 PM
News Source Link:
https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/609030/MHRA_GMP_Inspection_Deficiency_Data_Trend_2016.pdf
RegulatoryNewsDate:
Jul 5, 2017, 16:34 PM

MHRA released its annual report covering inspection findings of facilities producing drug product for the UK market in May. This report covers 324 inspections in 2016, of which 34% were of overseas facilities. Top deficiencies noted in the report included issues with quality systems, sterility assurance concerns, production problems, complaints/recalls, and more. MHRA releases this data publicly so companies can use it as part of continuous improvement.

regulatory-news-regions:
  • Europe