Hey Suzy! The auditors are here. Are our pipetmen calibrated?
Well, are they!!!!!!!!!
And so the story goes.....
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Agency Performing the Audit: CDER, Center for Dug Evaluation and
Research
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Story: A Related Story
This is a story that was related to me by another mass spectrometry lab supervisor. The FDA was auditing their mass spectrometry lab. UV data was being acquired and integrated during their LC/MS analyses. Occasionally their UV peaks would need to be manually reintegrated. Under certain chromatographic situations it is normal for automated integration programs to fail. One cannot always predict a small chromatographic anomaly that will upset an automated integration program. The need to manually adjust the base line in an integration is a common occurrence for anyone working in an analytical lab. The FDA inspector requested that he see the SOP that was used for the manual reintegration of the UV peak. The request was repeated several times by the inspector, "Where is the SOP that describes when and how peaks should be manually reintegrated?", of course they did not have this SOP in place.
(comment)
Anyone that is familiar with automated integration of chromatographic peaks understands that these computer programs fail from time to time during certain chromatographic circumstances. I believe that it was fair for the inspector to ask the question, but I also understand that it is a question that is not easily answered or easily described in an SOP. As difficult as it may be to have this UV integration SOP in place one would be well advised to have one. One must have a good defendable guideline in place.
-anonymous-