Wednesday, November 28, 2007

Regulators cite 'lack of knowledge and understanding'

A suggestion for a new SOP...

all process equipment should be cleaned at least every 5 years, or so...

The tank, in fact, was not cleaned at all between 2001 and the end of the company's April 2006 production run.

Following non-routine maintenance, the holding tank was then cleaned using ethanol according to SOP guidelines. Crucially, however, the tank was not dried afterwards to rid it of any residual ethanol.

The tank therefore still contained the alcohol when it was charged with the starting material, MSA. This resulted in a reaction that caused high levels of EMS in the Viracept starting material.

The official report into good manufacturing practice (GMP) failures that caused dangerous contamination and a Europe-wide recall of Roche's HIV drug Viracept (nelfinavir) claims the firm simply did not understand its own manufacturing processes.

The Committee for Medicinal Products for Human Use (CHMP) published its assessment yesterday, recounting the inspections and discussions that took place in the wake of the June recall and noting the "critical GMP deficiencies" that resulted in the suspension of Roche's Viracept marketing authorisation.

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 occurred.

Their examination revealed violations that not only led to the high-level contamination reported over the summer, but also led to questions regarding regular manufacturing processes and concerns over "the quality of Viracept and its safety under normal conditions of use."

link to full article

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