A lack of written procedures for preventing microbiological contamination of drugs has earned GlaxoSmithKline ($GSK) an FDA warning letter. A disinfectant for cleaning manufacturing areas was apparently unable to remove all of the required bacteria types, Dow Jones reports.
The letter, issued Oct. 7, was recently posted to the FDA website and involves the company's Worthing West Sussex, U.K., facility, which was inspected last March. GSK told the FDA after the inspection the failure of the disinfectant was due to the test conditions rather than efficacy. But an unimpressed FDA deemed that answer insufficient because the company "did not include documentation to support this conclusion," the letter states.
The agency also took exception to personnel gowning procedures used for aseptic filling. Workers sampled only the hood, goggles and sleeves. "Your personnel monitoring program should include appropriate sampling and practices to reflect whether personnel maintain asepsis during sterile drug manufacture."
The warning also includes a citation for technician failure to follow lab control procedures, as well as one for the quality control unit's ineffectiveness in approving procedures and specifications.
- here's the story
- see Warning Letter 320-12-01