Elan Corp.

You failed to respond to calibration failures of the ultraviolet (UV)/visible spectrophotometer as required by your procedures. Instruments were not taken out of service, logbooks did not reflect passing/failing calibrations, certificates of calibrations were incomplete, there was no investigation into the cause of failures and no record was maintained of the corrective action taken as required. The procedures for maintaining the dissolution equipment were inadequate to prevent frequent equipment malfunctions. Chronic problems such as valve blockages, actuator problems, air bubbles, filter clogs and software problems were noted on a recurrent basis over the past 18 months. The dissolution equipment with model _____ spectrophotometers have remained in use over the past 18 months although this model was identified by your firm in January 1996 as the cause of numerous OOS results due to frequent malfunctions. The continued malfunction of these units has impeded quality control procedures and monitoring.

You failed to properly validate the dissolution testing equipment. There was no raw data available for the installation qualification/operation qualification (IQ/OQ) for three of the spectrophotometers used in dissolution testing. Qualification data could also not be found for system _____ Systems _____ and _____ were placed into service prior to execution of IQ/OQ protocols. Although the spectrophotometer in system _____ failed photometric accuracy during IQ/OQ, this was not noted in the final approved report. There also were no procedures addressing qualification and/or calibration of dissolution equipment following changes in major components (such as UV lamps and computers).

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