A potential 483 area to look at is the refrigerators used in the lab. These units are overlooked when setting up a lab, but not by the inspecting auditors. These units are used to store samples between the scheduled pull date and the testing time. Having the support documents is critical when discussing the unit with the auditor.
When setting up a new lab, the process needs to look at not only the new incoming instruments, but also the support equipment. Product stored in refrigerators, have basically the same requirements for storage validation as the larger stability chambers used for storage prior to delivering the samples to the labs.
This unit is for sample storage only and should be labeled as such to make sure no food storage is allowed.
This unit should have an equipment logbook and an equipment file to track calibration, maintenance, excursions and associated documentation.
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