Drug Evaluation Committee 2014-39 Temperature Storage Methods for Investigational Drugs (Part 3)
Related classification: Other
Date of first publication: December 2014
Question
Currently, the storage and cold storage rooms where investigational drugs are stored at our hospital are not equipped with a validated thermometer, so we have installed a calibrated thermometer provided by the sponsor to control the temperature of the investigational drugs. In the future, we plan to purchase a validated thermometer, calibrate it annually, and manage it as our hospital.
When we asked about the situation at other hospitals using thermometers similar to those we plan to use, we were told, "We will replace the thermometers with new ones every year instead of calibrating them once a year, and we will guarantee it with a product warranty. We will replace the thermometers with new ones every year, and guarantee this with a product warranty," was one of the opinions we heard. I think replacing the thermometer with a new one is an option based on cost and other considerations, but is it safe to regard being within the product warranty period and having the thermometer calibrated as the same level of accuracy control?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Generally, the product warranty period is the period of time set by the manufacturer that the product will meet the specifications (performance, functions, etc.) predetermined at the time of design when used in the normal way. However, the actual performance, functionality, etc. of a measurement device depends on the individual product and the environment of transportation and use after shipment. In clinical trials, calibration and maintenance inspections must be performed and records kept even within the product warranty period to ensure that the measuring instruments actually perform (or have performed) the required performance, functions, etc. The method and frequency of calibration and maintenance differ depending on the product.
Although GCP does not specify specific methods for accuracy control, the July 1, 2013, Ministry of Health, Labour, and Welfare, Evaluation and Management Division, Secretariat, "Basic Concept on Accuracy Control of Clinical Laboratories in Clinical Trials," states, "Accuracy control ... is sufficient if records can be checked when necessary and are properly managed. It is sufficient if records can be checked when necessary and if they are properly managed. We recommend that accuracy control be conducted in a way that is appropriate for each medical institution, taking these points into consideration.