FDA warns GSK plant
pharmafile | June 26, 2014 | News story | Manufacturing and Production, Sales and Marketing | FDA, GSK, Quebec, flu, flulaval, vaccines
GlaxoSmithKline’s Canadian operation has incurred the displeasure of the US Food and Drug Administration for irregularities in its production of a flu treatment.
Flulaval is the company’s older flu drug, which has been to some extent superceded by Relenza – but FDA inspectors noted “deviations from current good manufacturing practice (CGMP) requirements” in its production at GSK’s plant in Quebec.
The inspection was carried out in early April, and the FDA sent the manufacturer a warning letter on 12 June regarding breaches of the Federal Food, Drug and Cosmetic Act and Public Health Service Act.
‘Significant deviations’ in the manufacture of Flulaval and its intermediates seen by the FDA’s inspectors included failure to assure that appropriate written procedures designed to prevent microbiological contamination of drug products – which should be sterile – are established and followed.
Among the main problems identified by the FDA were that manufacturing controls for the purified water system at the Quebec facility were “inadequate to prevent bioburden and endotoxin excursions”.
This meant the investigation concluded, that the endotoxin results for the plant have been atypical since May 2011. There is also no set schedule for disinfection of the plant’s water system.
GSK insisted that no contaminated products had been released to the public, Reuters reports.
“Every batch of GSK vaccines is subject to extensive review before it is released,” the company said. “Vaccines that do not pass this rigorous review are discarded.”
The FDA said the problems found by inspectors “are an indication of your quality control unit not fulfilling its responsibility to assure the identity, strength, quality, and purity of your licensed biological drug product and intermediates”.
While the warning letter acknowledged GSK’s commitment to put right the problems and prevent them in future, it says the company has so far “provided insufficient detail in your response”.
Further information and discussion is required, the FDA concludes.
Adam Hill
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