Dirty Tank Causes Contaminated Products Nov 27, 2007

The European Medicines Agency (EMEA) carried out an inspection of Roche's active ingredient manufacturing facility in Basel in collaboration with Swiss regulators Swissmedic, to assess conditions at the plant where the contamination of Viracept occurred.

They discovered a holding tank, used to store the starting material for the last step of the drug's manufacturing process, was not part of Roche's cleaning Standard Operating Procedure (SOP). The tank, in fact, was not cleaned at all between 2001 and the end of the company's April 2006 production run.

Perhaps one of the most unnerving aspects was that one of the root causes of contamination during Viracept's history was the "lack of knowledge and understanding with regard to the manufacturing process" exhibited by the drug's manufacturer.

"This may be due to the fact that the production process was originally purchased from another company," the assessment report suggests.

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