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."

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Counterfeit Toothpaste Imported From South Africa Recalled in 4 States

How difficult will this be?

WASHINGTON (AP) -- The Colgate-Palmolive Co. said Thursday that 5-ounce tubes of counterfeit toothpaste sold in discount stores in four states under a Colgate label are being recalled because they may contain a poisonous chemical.

A Food and Drug Administration official, Doug Arbesfeld, said Wednesday that testing had found the chemical in a product with the Colgate label, but said in the initial announcement that the FDA was unsure whether it really was Colgate or a counterfeit.

"We are aware that toothpaste is something that's been counterfeited in the past," he said. "We don't want to alarm people unnecessarily."

MS USA Trading, Inc. of North Bergen, N.J., the importer involved in the initial recall announcement, said the toothpaste may contain diethylene glycol, a chemical found in antifreeze.

The company said the toothpaste, imported from South Africa, was sold in discount stores in New Jersey, New York, Pennsylvania and Maryland.

"Made in South Africa" is printed on the box and includes Regular, Gel, Triple and Herbal versions.

The trading company said the problem was discovered in routine testing by the Food and Drug Administration. It said no illnesses have been reported to date.

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