Drug Evaluation Committee 2013-41 Temperature Control Methods for Investigational New Drugs
Related classification: Other
First published: December 2013
Question
I would like to ask a question regarding the temperature control of investigational drugs.
We store investigational drugs from several companies in one refrigerator, and the temperature is controlled by a thermometer provided by the sponsor as well as our own thermometer, and we measure the temperature daily.
Recently, a temperature deviation was found in the thermometer provided by Company B for the storage of investigational drugs. However, when we looked at the readings of the thermometer provided by Company A and the thermometer at our hospital, both thermometers were within the normal range, so we assume that there was no actual measurement problem. (According to the investigation by the thermometer manufacturer), there was nothing wrong with the function of the thermometer provided by Company B.
In order to avoid such a situation in the future, we believe that the site should have thoroughly controlled the accuracy of the thermometers and standardized their measurement, and that the sponsor should have checked the refrigerator temperature using the site's thermometer instead of each site providing its own thermometer. What is your opinion on this point?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
As long as the accuracy of the thermometer at the site is thoroughly controlled, the thermometer is installed in a location where the temperature in the storage is evaluated (taking into account temperature differences within the storage), and the temperature is appropriately recorded, there should be no problem with using the thermometers and records at each site.
However, there may be cases where individual requests (frequency of measurement, output format of records, installation of individual thermometers) are made depending on the contents of the study protocol and characteristics of the investigational drug. In such cases, the reasons and necessity of such requests should be discussed with the sponsor.