GlaxoSmithKline’s plant in Canada has been warned by the FDA over irregularities in production of a flu treatment.
It seems GlaxoSmithKline have hit the headlines again receiving a warning from the FDA for “deviations from current good manufacturing practice requirements”. This is based around the production of GSK’s flu treatments Fluaval and Relenza. The actual inspection took place in April but it wasn’t until June that GlaxoSmithKline received a letter 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.
The FDA identified amongst the main problems that the manufacturing controls for the purified water system at the Quebec facility were inadequate to stop bioburden and endotoxin excursions.
This brought the investigation to a conclusion, that the endotoxin results for the plant had been atypical since may 2011. There hasn’t been a set schedule yet for the disinfection of the plant’s water system. GSK have also insisted that no contaminated products have been released to the products.
“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 identified that the problems their inspectors had found were an indication that the quality control unit not fulfilling its responsibility, to make sure the identity, strength, quality, and purity of your licensed biological drug product and intermediates.
While the warning letter acknowledged GlaxoSmithKline’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”.
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