GSK warned by FDA about Worthing plant
pharmafile | October 25, 2011 | News story | Manufacturing and Production |
The US FDA has issued a warning letter to GlaxoSmithKline, noting that its manufacturing plant in Worthing, UK, failed to meet quality standards during a recent inspection.
Moreover, GSK’s response to the inspection report has been deemed inadequate, and the drugmaker is risking a block on approvals for products made at the plant unless it brings it up to code.
The inspection of the SmithKline Beecham facility in Worthing was carried out in March and found a number of violations, including a lack of written procedures designed to prevent microbiological contamination of sterile drug products.
Worthing is among the oldest plants in the GSK network, and has been manufacturing medicines since 1960. It specialises in the production of penicillin products – notably GSK’s Augmentin (amoxicillin and clavulanic acid) product – and employs around 1,000 staff in manufacturing, technical, and specialist support functions.
Specifically, the October 7 warning letter notes that GSK did not show convincingly that a disinfectant process for surfaces in the production area was effective in removing microorganisms. Various microbes were uncovered by testing after disinfection of vinyl, stainless steel, glass and wall laminate materials.
There were also failures associated with the gown monitoring procedures used by production staff in sterile production areas, and adherence to laboratory control procedures.
One incident cited by the FDA runs as follows: “A media fill conducted during January 2011 resulted in two contaminated units. Your firm attributed the failures to stopper bags left inside the Class 100 area for a long period of time. There is inadequate information available to support this conclusion.”
According to the FDA letter, GSK had intended to use the media fill data to extend the sterility holding times for ‘product contact components’, without the approval of its quality control unit.
As is the norm in these cases, GSK has 15 days to respond to the issues raised in the warning letter.
Phil Taylor
