Basic Documentation

 Establish corrective actions if monitoring shows
that a limit was exceeded
 Establish procedures to ensure the system is
working properly
 Establish effective record keeping. Records
must be retained for one to two years.
AIA 2006 Guidelines require refrigerators, coolers,
and freezers used in hospital dietary facilities to be
equipped with an audible and visible high and low
temperature alarm. The time of alarm shall be
automatically recorded.
10
The FDA
11
requires each freezer and cold storage
compartment used to store and hold food to be fitted
with an indicating thermometer, temperature
measuring device, or a temperature-recording
device to show the temperature in the compartment
accurately as well as an automatic alarm system to
indicate a significant temperature change. Accuracy
of measuring equipment must also be maintained.
Good Storage Practices
Pharmaceutical products include required storage
conditions on their labeling. These are the conditions
under which the expiration date is applied. The
storage requirements specified on the product label
must be observed throughout the distribution of the
pharmaceutical product. Label temperature warnings
reflect the results of real-time storage tests. USP
<1079> provides general guidance concerning the
storage of pharmaceutical products.
Cold Storage–Medicinal products labeled for cold
storage are stored in a refrigerator where the
temperature cannot exceed 8°C (46°F). Domestic
refrigerators are not suited for medicinal products
because they do not have the precise control
necessary to maintain temperature between 2°C and
8°C (36°F and 46°F).
Cool Storage–Medicinal products labeled for cool
storage are stored in a cool place where the
temperature is between 8°C and15°C (46°F and
59°F).
Controlled Room Temperature Storage–Medicinal
products labeled for room temperature are stored in
a room where the temperature can be between 20°C
and 25°C (68°F and 77°F); that results in a mean
kinetic temperature that is calculated not to be more
Page 4 of 6 Siemens Industry, Inc.
10. AIA Guidelines, 2006 Part 2.1 General Hospitals, Section
6.2.3.2(4), p. 102
11. FDA 21 CFR Part 110.40(e) and (f)
than 25°C (77°F); and that allows for excursions
between 15°C and 30°C (59°F and 86°F).
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Freezers–An increasing number of blood and
biotechnology products must be stored frozen.
These labeled products must be stored below -5°C
(23°F) (freeze) and below -15°C (5°F) (deep freeze),
or they may show a range of -15°C to -20°C (5°F to -
4°F).
Written Procedures and Record
Written procedures should be available to describe
the control and monitoring of storage temperatures
and the calibration of measuring devices.
Procedures should include alert and action limits
and the corrective actions to be taken if the
temperature falls outside these limits.
Designate one person to act as lead-person to
review monitoring records at least monthly. The
back-up person should learn proper storage
procedures and be familiar with monitoring reports.
The review of records should be part of the quality
control program.
Training
Suitable training should be provided for personnel
who handle medicinal products. Personnel should
know how to monitor temperatures and how to react
to situations where adverse temperatures are
identified. Procedures for temperature monitoring
should include:
 Frequency of monitoring
 Location of recording devices
 Acceptable temperature limits
 Calibration of monitoring devices
 Temperature mapping
 Alarms and corrective actions taken in event of
an temperature excursion
 Records
Calibration of Measuring Devices
Devices used to monitor controlled environments
should be calibrated at least annually against a
NIST-traceable reference device. Records should
include per- and post-calibration readings and
12. United States Pharmacopoeia (USP), Pharmacists’
Pharmacopeia 2005, p. 21
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