GSK manufacturing woes continue
pharmafile | July 8, 2014 | News story | Manufacturing and Production | Canada, FDA, GSK, Paxil, Vaccine, manufacturing
Health Canada has told GlaxoSmithKline that it wants to see the firm fix major problems at the country’s only flu vaccine production facility.
The London-based firm was given 30 days in which to lay out a proposal and timeline for resolving the problems at the facility, Health Canada tells The Canadian Press.
“We have 30 days to review and respond to the findings noted in their report and we are committed to doing so by 4 August 2014,” Michelle Smolenaars Hunter, communications manager for GSK Canada, tells the newspaper.
The specifics of the troubles Health Canada identified at the plant were not revealed, although the department said some related to infractions raised by the FDA in a warning letter about the facility that it issued last month.
This included problems linked to the plant’s water purification system. The FDA’s letter also said that since 2011, the company has ‘repeatedly discarded’ batches of vaccine because of bacterial counts that registered ‘above specified limits’.
It also noted that 21% of the plant’s production in 2014 could not be released to the market because of the problem. Health Canada says it is currently writing a summary report of its findings and will release it in due course.
“We will not hesitate to take firm and immediate action should a serious risk to public health and safety be found,” the department states, though it noted the situation does not pose an immediate threat to the health of Canadians.
This is because programmes to administer vaccine in advance of next winter’s flu season will not begin across the country until late October or November.
More M&P problems
GSK has been beset by a number of manufacturing issues this year, and at the beginning of 2014 it had to reallocate this year’s supply of chickenpox vaccine Varilrix – as well as Priorix Tetra for an MMRV given on-going problems at a plant in Belgium.
In April the firm was also slammed by the FDA over problems at its manufacturing site in Ireland, where the US regulator outlined a number of deviations from good manufacturing practice guidelines.
The issues related to the drug ingredient paroxetine, which is used to produce branded antidepressants Paxil and Seroxat, sales of which the FDA were threatening to block due to the contamination issues.
In March the firm also had to recall its OTC weight-loss drug Alli (orlistat) after ingredients ‘other than the drug’ were found in bottles of Alli.
Ben Adams
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