FDA Issues Warning Letter to GSK Biologicals

fruutuun

FDA issued a warning letter to GlaxoSmithKline Biologicals (GSK), North America on June 12, 2014 for deviations from cCGMP requirements found during an inspection from Mar. 31 to Apr. 9, 2014 of its influenza vaccine manufacturing facility in Quebec.

GSK is making progress in addressing FDA's concerns and is working to meet supply commitments, the company said in a press release.

Problems observed included failure to assure that appropriate written procedures designed to prevent microbiological contamination of drug products are established and followed, such as validation of all aseptic and sterilization processes. FDA also observed deviations in manufacture of intermediates, including inadequate controls for the purified water system and for manufacturing processes. FDA noted that controls are inadequate to prevent bioburden and endotoxin excursions.

发现问题包括公司没有确保建立和跟踪预防产品微生物物污染的相关流程，如无菌和消毒流程的验证。FDA同时发现中间体制造过程中的偏差，包括生产用纯化水的控制不充分。FDA注意到生物负荷和内毒素的预防不充分。

FDA acknowledged the company's commitments of corrective and preventive actions. FDA said that GSK had not provided sufficient detail, however, and the agency requested a meeting with senior management. FDA认可公司的CAPA承诺。FDA认为GSK没有提供充分的详细材料，然而机构要求和资深管理层开过一次会议。【水平有限，翻译不好见谅】

355184470

GSK真的其实是个好公司 只是最近倒霉了

dabenjack

不错，谢谢分享

道路漫长黑暗

楼主这个warning letter是几月的怎么找不到啊

fruutuun

June 12, 2014