[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR111.3]
[Page 228-230]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 111_CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS--Table of Contents
Subpart A_General Provisions
Sec. 111.3 What definitions apply to this part?
The definitions and interpretations of terms in section 201 of the
Federal Food, Drug, and Cosmetic Act (the act) apply to such terms when
used in this part. For the purpose of this part, the following
definitions also apply:
Actual yield means the quantity that is actually produced at any
appropriate step of manufacture or packaging of a particular dietary
supplement.
Batch means a specific quantity of a dietary supplement that is
uniform, that is intended to meet specifications for identity, purity,
strength, and composition, and that is produced during a specified time
period according to a single manufacturing record during the same cycle
of manufacture.
Batch number, lot number, or control number means any distinctive
group of letters, numbers, or symbols, or any combination of them, from
which the complete history of the manufacturing, packaging, labeling,
and/or holding of a batch or lot of dietary supplements can be
determined.
Component means any substance intended for use in the manufacture of
a dietary supplement, including those that may not appear in the
finished batch of the dietary supplement. Component includes dietary
ingredients (as described in section 201(ff) of the act) and other
ingredients.
Contact surface means any surface that contacts a component or
dietary supplement, and those surfaces from which drainage onto the
component or dietary supplement, or onto surfaces that contact the
component or dietary supplement, occurs during the normal course of
operations. Examples of contact surfaces include containers, utensils,
tables, contact surfaces of equipment, and packaging.
Ingredient means any substance that is used in the manufacture of a
dietary supplement and that is intended to be present in the finished
batch of the dietary supplement. An ingredient includes, but is not
necessarily limited to, a dietary ingredient as defined in section
201(ff) of the act.
In-process material means any material that is fabricated,
compounded, blended, ground, extracted, sifted,
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sterilized, derived by chemical reaction, or processed in any other way
for use in the manufacture of a dietary supplement.
Lot means a batch, or a specific identified portion of a batch, that
is uniform and that is intended to meet specifications for identity,
purity, strength, and composition; or, in the case of a dietary
supplement produced by continuous process, a specific identified amount
produced in a specified unit of time or quantity in a manner that is
uniform and that is intended to meet specifications for identity,
purity, strength, and composition.
Microorganisms means yeasts, molds, bacteria, viruses, and other
similar microscopic organisms having public health or sanitary concern.
This definition includes species that:
(1) May have public health significance;
(2) May cause a component or dietary supplement to decompose;
(3) Indicate that the component or dietary supplement is
contaminated with filth; or
(4) Otherwise may cause the component or dietary supplement to be
adulterated.
Must is used to state a requirement.
Pest means any objectionable insect or other animal including birds,
rodents, flies, mites, and larvae.
Physical plant means all or any part of a building or facility used
for or in connection with manufacturing, packaging, labeling, or holding
a dietary supplement.
Product complaint means any communication that contains any
allegation, written, electronic, or oral, expressing concern, for any
reason, with the quality of a dietary supplement, that could be related
to current good manufacturing practice. Examples of product complaints
are: Foul odor, off taste, illness or injury, disintegration time, color
variation, tablet size or size variation, under-filled container,
foreign material in a dietary supplement container, improper packaging,
mislabeling, or dietary supplements that are superpotent, subpotent, or
contain the wrong ingredient, or contain a drug or other contaminant
(e.g., bacteria, pesticide, mycotoxin, glass, lead).
Quality means that the dietary supplement consistently meets the
established specifications for identity, purity, strength, and
composition, and limits on contaminants, and has been manufactured,
packaged, labeled, and held under conditions to prevent adulteration
under section 402(a)(1), (a)(2), (a)(3), and (a)(4) of the act.
Quality control means a planned and systematic operation or
procedure for ensuring the quality of a dietary supplement.
Quality control personnel means any person, persons, or group,
within or outside of your organization, who you designate to be
responsible for your quality control operations.
Representative sample means a sample that consists of an adequate
number of units that are drawn based on rational criteria, such as
random sampling, and that are intended to ensure that the sample
accurately portrays the material being sampled.
Reprocessing means using, in the manufacture of a dietary
supplement, clean, uncontaminated components or dietary supplements that
have been previously removed from manufacturing and that have been made
suitable for use in the manufacture of a dietary supplement.
Reserve sample means a representative sample of product that is held
for a designated period of time.
Sanitize means to adequately treat cleaned equipment, containers,
utensils, or any other cleaned contact surface by a process that is
effective in destroying vegetative cells of microorganisms of public
health significance, and in substantially reducing numbers of other
microorganisms, but without adversely affecting the product or its
safety for the consumer.
Theoretical yield means the quantity that would be produced at any
appropriate step of manufacture or packaging of a particular dietary
supplement, based upon the quantity of components or packaging to be
used, in the absence of any loss or error in actual production.
Water activity (aw) is a measure of the free moisture in
a component or dietary supplement and is the quotient of
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the water vapor pressure of the substance divided by the vapor pressure
of pure water at the same temperature.
We means the U.S. Food and Drug Administration (FDA).
You means a person who manufactures, packages, labels, or holds
dietary supplements.