Basic Documentation

Guidelines
3
developed by the National Cancer
Institute (NCI) recommend the following be
incorporated into protocols used for the collection of
bio-specimens:
 Base protocols on SOPs that are established
using best practices.
 SOPs should be printed and available to all
laboratory personnel and dated according to
most recent revision.
 Staff must be trained in QA/QC and maintain
training records.
 Establish security systems, including equipment
monitoring and alarm systems, both locally and
remote.
 Emergency power should be available to all
critical equipment during power outages.
Biological Products
Biological products for human use include: gene,
cell, blood, tissue and organ therapies, and include
products intended for transplantation, transfusion,
vaccines, and xenografts.
High-risk products such as vaccines, insulin, and
blood products (such as Factor VIII), which are
normally stored between 2° and 8°C (36° and 46°F),
must be protected from freezing; even a brief period
of sub-zero temperatures can cause loss of efficacy.
Temperature should be monitored by an electronic
temperature recorder that should be readable from
outside the refrigerator.
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The FDA
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requires equipment to be observed,
standardized and calibrated on a regularly schedule
basis as prescribed in the Standard Operating
Procedures Manual. Temperatures shall be
recorded daily and calibrated as necessary. Records
of storage temperature and proper maintenance will
be kept for a retention period of no less than five
years.
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Siemens Industry, Inc. Page 3 of 6
3. First-Generation Guidelines for NCI-Supported
Biorepositories, National Cancer Institute/Nations Institute of
Health, April 2006
4. Taylor, John. Recommendations on the Control and
Monitoring of Storage and Transportation Temperatures of
Medicinal Products, The Pharmaceutical Journal, Vol. 267,
July 2001 pp 128-131
5. FDA 21CFR Part 606 and Part 640
6. FDA 21CFR Part 606.160(b)(3) and (d)
Good Storage Practices
FDA regulations do not provide direction on
temperature conditions for storage. U.S.
Pharmacopoeia (USP) provide definitions for
storage conditions found on product labels.
Pharmaceutical products include required storage
conditions on their labeling. These are the conditions
under which the expiration date is applied.
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 can
not 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° and 8°C (36° and 46°F).
Refrigerators should be located in an environment
where the ambient temperature does not affect the
temperature control within the unit.
Cool Storage
Medicinal products labeled for cool storage are
stored in a cool place where the temperature can be
between 8° and15°C (46°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° and 25°C (68°and 77°F); that results in
a mean kinetic temperature that is calculated not to
be more than 25°C (77°F); and that allows for
excursions between 15 and 30°C (59°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 (freeze) and
below -15°C (deep freeze) or the may show a range
(for example, -15°C to -20°C).
Calibration of Measuring Devices
Devices used to monitor temperature in storage
areas should be calibrated at least annually against
a NIST-traceable reference device. Records should
include pre- and post-calibration readings and
details of any adjustments made or corrections
7. USP Pharmacopeia 2005, p 21
Document No. 1
49-925