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Temperature and Storage Conditions Top the List of Major/Critical Deficiencies in MHRA GDP Inspections

Oct 1st, 2010

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Temperature and storage conditions were the most common Good Distribution Practice (GDP) deficiencies ranked “major” and “critical” by the UK Medicines and Healthcare products Regulatory Agency (MHRA) during inspections conducted from January to June of 2010.

The temperature and storage problems made up over one-quarter (27%) of all major/critical GDP inspection observations during that period, up from second place during the six months prior to that.

MHRA’s Inspection, Standards and Enforcement division includes one inspectorate dedicated to GDP inspections, three dedicated to GMP inspections, and a group of expert inspectors.  The GDP inspectorate conducts inspections of companies that manufacture or wholesale medicinal products.  GDP inspections began for holders of wholesale dealer licenses in April 2009.

The GDP inspectorate follows a risk-based model for inspections.  Inspections of UK sites are carried out whenever a company applies for or is named on a license, and again within 15 months to determine its risk ranking.

The ranking is determined based on the range of products, size of the operation, and other factors specific to the operation, e.g. warehousing and shipment of cold chain products.  Subsequent inspection frequency is based on the risk ranking, which can change depending on the inspection history of the site.

[More on the types of serious GDP efficiencies that are surfacing during MHRA inspections is provided for subscribers along with links to relevant documents on page 2.  For subscription information, click here.]

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