Encore une société indienne épinglée pour manquements répétés à la "data integrity"...
Cette société indienne a reçue une mise en demeure sévère sur plusieurs points liés à la "data integrity" : 1. Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to assure compliance with established specifications and standards (21 CFR 211.194(a)). Your laboratory records did not contain all raw data generated during each test for finished drug products manufactured at your firm. Your quality unit relied on incomplete records to make batch release decisions in support of regulatory submissions to the Agency. During the inspection, your management acknowledged that employees in your QC laboratories conduct trial HPLC injections prior to the injections submitted as the reported test results . These trial injection data files were stored on separate drives from the reported test result data. In some cases original data files were deleted. The results from these trial injections and other original data were n...
