Warning Letter: Failure to prevent unauthorized access or changes (ucm421544_Amended)

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Ofni Systems

Your firm released [redacted] API batch [redacted] with an unknown peak present in the residual solvents chromatogram. Although this unknown peak was not a part of your historical impurity data, neither the analyst nor the supervisor apparently noticed or evaluated this unknown peak during their reviews.

Subsequently, a customer complaint was received for this batch, and your investigation identified the unknown peak as [redacted]. Your firm found that this peak was a result of a contamination that occurred during your manufacturing process.

In response to this letter, provide the corrective actions implemented to ensure that all laboratory data is appropriately analyzed, accurately reported and approved by your quality unit.
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 the unauthorized manipulation of your electronic raw data. For example,

a. The inspection found that the audit trail feature for your gas chromatography (GC) instruments was not used until October 2013, even though your 2009 GC software validation included a satisfactory evaluation of the audit trail capability.

b. There is no assurance that you maintain complete electronic raw data for the [redacted] GC instruments, the Malvern particle size analyzer, and the ultraviolet (UV) spectrophotometer. Our inspection found that these instruments were connected to stand-alone computers that stored the data and that the data could be deleted.

c. Prior to our inspection, your firm failed to have a back-up system for the data generated by one of the [redacted] Fourier transform infrared spectrometers, the polarimeter, the UV spectrophotometer and the Malvern particle size analyzer.

View the original warning letter.


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