The QMN Weekly Bulletin
Pharmaceuticals / Quality / Regulatory Affairs

UK's MHRA Shuts Down GcMAF Plant

Feb. 27, 2015
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UK regulators shut down a plant in Cambridgeshire that was producing an unapproved and unlicensed product used against diseases such as HIV and cancer.

The Medicines and Healthcare products Regulatory Agency surprised the plant with an inspection, following notice from the local medicines regulator, the agency said. Inspectors seized 10,000 vials of the product after discovering that the plasma being used to make Globulin component Macrophage Activating Factor (GcMAF) was labeled “not to be administered to humans or used in any drug products.”

They also concluded that the production site did not meet good manufacturing practices and that the GcMAF, and the equipment used to make it, may have been contaminated.

A contaminated blood product could lead to adverse events such as infection, MHRA spokesman Nick Spears said. Spears stressed that no such events have yet been reported.

GcMAF, which is designed to stimulate immune cells to kill cancer cells and other diseases, was sold through a number of websites in the UK and the rest of Europe, MHRA says. It is commonly known as “First Immune.”

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