“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)).
QC personnel created unauthorized folders on laboratory computerized systems without appropriate oversight. Our review of the HPLC Empower III data collected in 2013-2014 in the commercial QC laboratory found a data folder entitled “WASH.” According to your management, the folder was intended for column wash injections using blank solvent prior to and following sample runs, although you have no standard operating procedure (SOP) detailing this process. One of your laboratory analysts stated that this folder does not contain any standard or sample injection results. However, our investigator found that this folder contained a total of 3,353 injection results, some of which appeared to be samples.
As part of your comprehensive evaluation and risk assessment, include a detailed description of all computerized systems in your facility used for testing drugs. This description should include information on each electronic folder that was not created pursuant to a valid SOP and an assessment of every file in each such folder, including information about the sample (product), date of test, lot number and original test result over the last five (5) years, except for data relating to exhibit batches, in which case there is no time limitation. Also provide specific information about all retests during these time frames, where an initial out-of-specification or out-of-trend result was disregarded without an investigation and the date on which you became aware such information had been disregarded. In addition, for each batch, provide the number of injections performed and chromatograms reviewed, and of those, the number that were used to generate a reported result. Furthermore, provide an updated assessment on the possible effects of your firm’s practices on the quality, safety, and efficacy of the drugs you manufacture or plan to manufacture, including drugs covered by approved or pending applications.
Also describe the procedures established to manage and retain all computerized data.
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