During the inspection, our investigator observed that many of your computerized systems lacked sufficient controls to ensure the integrity of the data being generated. For example:
Our investigator found “System/Administrator” as the only user role for your [redact] software. There were no restrictions on deleting or modifying data for this user role. [redact] was used for assay and identity testing of finished thyroid, USP API from March 2021 to November 2021.
Our investigator observed numerous deviations to original peak area results for HPLC assays of finished thyroid, USP API validation lots. There was no documentation of these alterations, but your quality unit personnel stated this may have been due to an unapproved update to the [redact] HPLC equipment. This equipment was never qualified according to your quality unit personnel.
A non-validated Excel spreadsheet was utilized to calculate finished thyroid, USP API assay results for all validation lot assay calculations. The formulas and outputs of the spreadsheet were printed at the time of the calculation and not saved. You were unable to provide an electronic copy of the original spreadsheet or master spreadsheet during the inspection.
Manufacturing master batch records held in electronic form on your company’s shared drive do not have restrictions on user access. Your quality unit personnel stated that there are no restrictions for any personnel with login credentials to access new and obsolete master records. Our investigator observed during the inspection multiple versions of batch records were utilized for API lot production.