Des enregistrements "falsifiés" pour ce fournisseur d'API...
3. 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)). While reviewing gas chromatography data on instrument QA/G07, our investigator found unreported results, including an out-of-specification (OOS) test result for raw materials. You did not investigate this OOS result or explain why you excluded the failing result from the official record. Our investigator also found that you reported only two of three chromatographic injections of sterile (b)(4) batch (b)(4) during in-process (b)(4) sample testing for residual solvent. You did not explain why you excluded the third injection. You decommissioned this instrument in July 2014 without reviewing the instrument data...
4. Your firm failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records, or other records (21 CFR 211.68(b)). Our investigator found that you have not validated 12 computerized systems in your quality control laboratory. These systems are used for your stability chambers, ultraviolet (UV) and infrared (IR) spectrophotometers, and for thin layer chromatography (TLC)...
5. Failure to record activities at the time they are performed, and destruction of original records. Data Recorded in Personal Diaries (Unofficial Notebooks)In your process development laboratory, our investigator found several unofficial notebooks recording sample preparation for OOS investigations, route-of-synthesis experiments, and scale-up data. Our investigator found discrepancies between these unofficial notebooks and the official data retained by your quality unit. Destruction of CGMP DocumentationCGMP documentation was discarded without being assessed by your quality unit. Our investigator found torn and shredded equipment maintenance documents, raw material labels, and change control work orders in your scrap yard awaiting incineration. Your staff lacked knowledge of your corporate procedure for the destruction and incineration of documents.
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