The practical aspects of quality assurance in Good Laboratory Practice studies in an emergency situation

In this report, the damage and countermeasures taken in relation to the Great Hanshin Earthquake are described. We report on the measures taken to counter damage in affected Good Laboratory Practice (GLP) studies by citing concrete examples. Case A: the testing facility was not affected, but a regulatory inspection had been scheduled for this day. Fortunately, official inspectors had reached the facility on schedule. Case B: The building for toxicology experiments was destroyed. Fortunately, most of the GLP-compliant experiments had been completed except one, the preparation of histological samples that was the last stage of the experiment. We asked the regulatory authority for appropriate countermeasures. The answer was that an inspection of the study could be conducted if an inspection is judged to be necessary. Case C: A necropsy was scheduled on this day. The study director decided that the necropsy should be postponed at least 1 week until he could secure the number of researchers needed to conduct the necropsy. Case D: The facility in Itami was destroyed. The facility was closed and the animals were moved to Kobe. The animal facility in Kobe was not affected, but because water supply stopped for 3 days, stocked water was used. Case E: Damage to computer systems in Kinki area was reported. Numerous computers fell from desks or were damaged from the impact shock. With the exception of a few, most of the damaged computers were repaired.