Deviations from “Good Manufacturing Practices” the rule/ the Australian

An FDA inspection uncovered multiple significant deviations from standard manufacturing processes, termed “good manufacturing practices” at CSL (previously known as Commonwealth Serum Laboratories, and previously an Australian government lab) in its manufacture of flu vaccine for the US market.  As is standard in these cases, a disclaimer was made to the effect that there is no evidence any patients were harmed.

The story grew, after The Australian investigated inspections of Australia’s pharmaceutical companies by the Australian equivalent of the FDA, the Therapeutic Goods Agency.  Of 139 sites inspected during the last financial year, only 3 were free of any deficiencies.  Corrective action was required at 136 sites.

I don’t know how to find similar stats for the US.  Given that many Australian pharma companies are subsidiaries of US companies, they are likely to be similar.

UPDATE (The Australian):  DOCTORS are demanding an official all clear from the nation’s drug regulator about the safety of swine flu vaccines. This follows US concerns over Australian pharmaceutical giant CSL.  Australian Medical Association vice-president Steve Hambleton yesterday said GPs were still waiting for the Therapeutic Goods Administration to officially inform them about discolouration in multi-use vials of the Panvax vaccine.

“We would want them to provide further reassurances that we can maintain our confidence in the stockpile which is in many doctors’ surgeries around the country,” he said.  The Australian revealed yesterday that the TGA had waited until US authorities blew the whistle on vaccine production at CSL’s Melbourne laboratory in April, before launching its own inquiry into discoloration of the nation’s stockpile of swine flu a month later. The TGA told The Australian on Wednesday that the remaining 9.4 million doses of Panvax stockpiled by the federal government did not pose a safety risk. Testing has failed to reveal the cause of the discoloration.
The US Food and Drug Administration has written to CSL criticising “deviations from current good manufacturing practice requirements”, and singled out the presence of black particles in multi-dose vials of seasonal flu vaccine made for the American market. 

At the time of the US inspection, the TGA had suspended use of CSL’s seasonal flu vaccine for young children after it had triggered febrile convulsions at nine times the usual rate. The TGA has ruled out any link between problems with the paediatric flu shot and the discoloration in the swine flu vaccine.  A CSL spokeswoman yesterday said the TGA “did not find any safety issues” in an audit of CSL’s laboratories last month.

The Gillard government yesterday handed CSL, a listed company, $30m of taxpayer funds for research and development.

More than 100 Australian children suffered febrile fits before the seasonal flu vaccine — a combination of seasonal and swine flu strains — was suspended for healthy under-fives in April.

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