lundi 27 avril 2015

Une autre mise au point de la FDA...



La US FDA vient d'épingler une nouvelle société pharmaceutique à son tableau de chasse "Data Integrity" pour les manquements principaux suivants :


1.    Failure to prevent unauthorized access or changes to data and to provide adequate controls to prevent omission of data. You lacked controls to prevent the unauthorized manipulation of your laboratory's electronic raw data. Specifically, your infrared (IR) spectrometer did not have access controls to prevent deletion or alteration of raw data. Furthermore, the computer software for this equipment lacked active audit trail functions to record changes to data, including information on original results, the identity of the person making the change, and the date of the change. Audit trails that capture such critical data about the quality of your batch production should be reviewed as part of the batch review and release process.
2.    Failure of your quality unit to ensure that materials are appropriately tested and the results are reported.  The inspection documented that an analyst at your firm failed to perform the IR identity test for all lots of (b)(4), API, as part of your quality control release. Instead, the analyst at your firm altered the file name in the spectrophotometer containing the sample identification information for (b)(4) API lot # (b)(4), tested on April 2, 2014, to support the release of two previously manufactured lots, # (b)(4) and (b)(4)


Il ressort de cette mise en demeure que les manipulations frauduleuses de données sont activement recherchées par l'agence et que l'audit trail sur les systèmes de mesure doit être systématiquement configuré ; par ailleurs la FDA rappelle que l'audit trail se rapportant à chaque analyse doit être vérifié lors de la revue du dossier de contrôle.

Plus d'information ici.