Drug Evaluation Committee 2014-06 Temperature Storage Methods for Investigational Drugs (Part 2)
Related classification: Other
Date of first publication: June 2014
Question
Currently, the refrigerator in which investigational drugs are stored at our hospital has not been validated, so a calibrated temperature logger is placed inside the refrigerator to control the temperature of the investigational drugs. In the future, we plan to purchase a validated refrigerator and calibrate and control it annually. Under these conditions, is it acceptable to store and manage the data recorded by the thermometer built into the refrigerator (paper or electronic) and not keep a separate temperature logger record as a record of accuracy control?
The contents of the validation will be as follows
- Basic operation (1. temperature setting can be implemented as instructed, 2. high temperature alarm and door alarm, 3. temperature display)
- Temperature performance inside the chamber
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
If it is guaranteed (validated) that the built-in thermometer in a refrigerator can correctly indicate and record the internal temperature through periodic calibration, we do not think it is necessary to keep a separate temperature logger record. However, if the internal thermometer is powered by the same power source as the refrigerator, it is necessary to prepare for unforeseen circumstances so that the temperature can continue to be measured and recorded even in the event of a power failure or disaster.
The temperature data must be preserved because the sponsor may request to view or submit the temperature record data.
In addition, depending on the content of the study protocol and the characteristics of the investigational drug, individual measures (measurement frequency, record output format, installation of individual thermometers, etc.) may be requested. In such cases, the reasons for and necessity of such measures should be discussed with the sponsor.
Please also refer to previous Opinion 2013-41.