Basic Documentation

maintain storage environments to ensure
product integrity and stability, including
appearance, until it reaches the end user.
Who enforces the Guidelines?
The FDA and the Center for Biologics Evaluation
and Research (CBER) regulate biological products.
The FDA is responsible for protecting public health
by assuring the safety, efficacy, and security of:
 Human and veterinary drugs
 Biological products
 Medical devices
 National food supply
 Cosmetics
 Products that emit radiation
The CBER is responsible for ensuring:
 The safety of the National blood supply
 Production and approval of childhood vaccines
 Oversight of human tissue used for
transplantation
 The supply of allergenic materials and antitoxins
 The safety and efficacy of all biological
therapeutics
Finished Drug/Therapeutic Product
Therapeutic products are defined as pharmaceutical
products for human and animal use (including active
pharmaceutical ingredients, finished dosages and
radiopharmaceutical products.
21CFR Part 211.46(b) states that:
“Equipment for adequate control over air
pressure, micro-organisms, dust, humidity, and
temperature shall be provided when appropriate
for the manufacture, processing, packing, or
holding of a drug product.”
21CFR Part 211.68(a) states that:
“Automatic, mechanical, or electronic equipment
or other types of equipment, including
computers, or related systems that will perform a
function satisfactorily, may be used in the
manufacture, processing, packing, and holding
of a drug product. If such equipment is so used,
it shall be routinely calibrated, inspected, or
checked according to a written program
designed to assure proper performance.”
21CFR Part 211.142 states that:
“written procedures describing the warehousing
of drug products shall be established and
followed. They shall include:(b) Storage of drug
products under appropriate conditions of
temperature, humidity, and light so that the
identity, strength, quality, and purity of the drug
products are not affected.”
21CFR Part 211.166 (a) states that:
“The results of stability testing shall be used in
determining appropriate storage conditions and
expiration dates.”
21CFR Part 211.180(a) states that:
“…any production, control, or distribution record
that is required to be maintained in compliance
with this part and is specifically associated with
a batch of a drug product shall be retained for at
least 1 year after the expiration date of the batch
or, in the case of certain OTC drug products
lacking expiration dating for at least 3 years after
distribution of the batch.”
Nonclinical Research Laboratories
Nonclinical laboratories are those which conduct
studies that support or are intended to support
applications for research or marketing permits for
products regulated by the FDA.
21CFR Part 58.61 states that: Equipment used in
the generation, measurement, or assessment of
data and equipment used for facility environmental
control shall be of appropriate design and adequate
capacity to function according to the (study) protocol
and shall be suitably located.
21 CFR Part 58.63(a) states that: Equipment shall
be adequately inspected, cleaned, and maintained.
Equipment used for the generation, measurement,
or assessment of data shall be adequately tested,
calibrated and/or standardized.
21 CFR Part 58.107 requires that: Procedures be
established for the handling of the test and control
articles to ensure that: (a) There is proper storage.
21 CFR Part 211.195(b) requires the long-term
storage of data generated for a nonclinical
laboratory study to be archived for a minimum of two
years but the maximum length depends on usage.
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