Des nouvelles injonctions de l'US FDA pour des sites chinois
1. Failure to prevent unauthorized access or changes to data and failure to provide adequate controls to prevent manipulation and omission of data... a. Our investigator’s review of the audit trail for the residual solvent stability testing indicated that an analyst manipulated your computerized gas chromatography (GC) system to falsify residual solvent stability results for multiple batches of (b)(4) API distributed to the U.S. For example, on March 4, 2016, your analyst set the GC personal computer (PC) clock back to make it appear as if testing had been done seven months earlier – on August 3, 2015. The analyst then performed five different injections to produce falsified results for long term stability 25C/65% RH 12 month time-point residual solvent testing for finished API lot (b)(4). The analyst deleted the first four backdated results and reported only the results of the fifth and final injection as passing in the quality control data package. Your quality unit relied on this incomplete data package to evaluate the quality of this lot of API and determine whether it was within specification. Our investigator observed that long-term stability results for at least five other lots of (b)(4) API were falsified using this technique of setting back the clock on the GC personal computer and then performing multiple injections until favorable results were obtained. Your firm failed to prevent analysts’ access to manipulate and delete laboratory data. In addition, your laboratory equipment lacked software controls to assure data integrity. b. Our investigator’s review of the audit trails for the high performance liquid chromatography (HPLC) system indicated that, just prior to the completion of certain stability analyses for (b)(4) API, analysts routinely aborted the ongoing tests to prevent your HPLC system from recording some assay and impurities test data. Your HPLC system, controlled by Chemstation software, was configured to automatically delete the results if a test was aborted prior to completion. Our investigator’s review of the system’s limited audit trails indicated that when an analyst aborted assay and impurities tests, the partial results from the aborted tests were automatically deleted from your computerized HPLC system’s records.Et encore :
1. Failure to have laboratory control records that include complete data derived from all tests conducted to ensure compliance with established specifications and standards. Your laboratory personnel conducted “unofficial” testing without appropriate documentation, justification, and investigation. The original, unofficial analyses were stored in a separate “Test” folder and were not part of the official quality control records. Our inspection found that your firm performed circa 8,400 of these unofficial chromatographic analyses between 2012 and 2014. According to your SOP-B-QC-022-01, Instrument Use Standard Operating Procedure, analysis of samples must be documented. The volume of data in these auxiliary “Test Folders” suggests that performing unofficial analyses is a common practice at your facility.
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