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Stories from a GCP inspector – part 5

by Katarina Thor

How IMP meets its end, sometimes in very surprising ways

Various Approaches to IMP destruction: Open fire

    Sometimes your instincts kick in as an inspector, and this was one of those moments. During one inspection, we asked to see where the study drug was destroyed, since the site insisted it was all handled on‑site. The investigator immediately agreed, but said we’d need to wait two to three hours.

    When we asked why, he couldn’t give a clear answer. And of course, that’s when the inspector brain starts buzzing: What are they hiding? What’s being “prepared” right now?

    As it turned out, the truth was far less dramatic, but unexpectedly charming.
    They needed time to cut the grass around the destruction area, to make sure there were no snakes. Once we heard that, we were more amused than suspicious and very appreciative of the effort.

    But then came the real issue. Their destruction method? An open fire.
    And the IMP? In glass vials, which meant that after burning, the only thing destroyed was the label, so it turned out to be a quite severe finding.

    The many (and sometimes questionable) ways IMP is destroyed: Pharmacy was gone!

    In this case, the picture really speaks for itself. Neither the sponsor nor the inspectors had any idea that the pharmacy was being demolished. When we arrived, instead of a functioning facility, we were met with torn walls, tools everywhere, and a space clearly mid‑renovation. It was an unexpected surprise for everyone and a moment where no explanation was really needed.

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