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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Key Insight
With mergers and acquisitions within the FDA regulated industries comes the danger of losing key "institutional knowledge." This is also critical in companies in a "downsizing" mode and/or where early retirements are encouraged as a means to cut costs.

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China Gets Serious on Drug GMP - Nov 19, 2007

Effective January 1, 2008, China's State FDA will no longer tolerate the detection of any "severe defects" during a GMP accreditation process, meaning that such a finding will result in automatic failure.

China has only been requiring pharmaceutical manufacturers to comply with GMP since 2004, and has granted accreditation if less than three "severe defects" are discovered. An example of a "severe defect" is the falsification of application documents.

The US FDA and China's SFDA have been working together for the past six months on a safety pact between the two countries. Looks like there's some real progress being made here.

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To our US based readers, have a Happy Thanksgiving holiday.
Read FDA's article - Home for the Holidays: Preventing Foodborne Illness at Family Gatherings
Find it at http://www.cfsan.fda.gov/~dms/fdholida.html

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The FDA Just Can't Win - Nov 13, 2007

The FDA is damned if it does, and damned if it doesn't. A recent article in Fortune states that after years of public ridicule and congressional scrutiny, the FDA is taking a tougher stance against drugmakers in its review of new medicines. That new cautiousness, however, rankles its most powerful constituents: Big Pharma CEOs who charge that the agency is standing in the way of new medicines - and progress.

So is the FDA really to blame?

An interesting assessment of FDA's relationship with our industry.

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GMP Training Systems, Inc.
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Serving 1288 clients since 1996

JUST RELEASED! NEW INNOVATIVE PRODUCT!
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