【讨论】美国FDA发出警告信给葛兰素史克生物制品FDA Issues Warning Letter to GSK...

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美国FDA发出警告信给葛兰素史克生物制品

FDA对从cCGMP要求有偏差从3月31日视察了在魁北克省的流感疫苗生产工厂，以2014年4月9日在发现发出警告信，葛兰素史克生物制品（GSK），北美地区于2014年6月12日。
葛兰素史克公司正在解决FDA的关注进展，并正在努力满足供应的承诺，该公司在一份新闻稿中说。
观察到的问题包括故障，以确保设计的，以防止药品微生物污染适当的书面程序，建立和落实，如所有的无菌和消毒过程的有效性。 FDA还观察到制造的中间体，包括净化水系统和制造工艺控制不足的偏差。 FDA指出，控制是不足以防止生物负荷和内毒素游览。
美国FDA认可的纠正和预防措施，公司的承诺。 FDA表示，葛兰素史克公司并没有提供足够的细节，但是，该机构要求与高级管理人员会面。
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.
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.

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