Warning Letter: Failure to have proper controls (ucm421988)

Failure to prevent unauthorized access or changes to data and to provide adequate controls to prevent omission of data.

Your firm did not have proper controls in place to prevent manipulation of your laboratory’s electronic raw data. Specifically, your NuCon 5700 gas chromatographs (GCs) did not have access controls that would prevent the deletion or altering of raw data files. In addition, the GC software lacked active audit trail functions to record any changes to the data, including the previous entries, who made the changes, and when the changes were made. The use of audit trails for computerized analytical instrumentation is essential to ensure the integrity and reliability of the electronic data generated.

During the inspection, your management explained that the laboratory practice was to delete the raw data files once the chromatograms were printed. As such, your firm did not retain complete raw data from testing to ensure the quality of your APIs. Specifically, electronic raw data files, supporting your GC testing for release (assay) were deleted.

Failure to have appropriate controls for issuance of batch records.

Our inspection found that batch records were uncontrolled in that operators had the ability to print batch records from their personal computers. In addition, various uncontrolled blank manufacturing batch records were found in a binder located in the production office.

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