21
Code of Federal Regulations
Parts
210
210.1 Status of current good manufacturing practice regulations.
210.2 Applicability of current good manufacturing practice regulations.
210.3 Definitions.
§ 210.1 Status of current good manufacturing practice regulations.
(a) The regulations set forth in this part and in Parts 211
through 226 of this chapter contain the
minimum current good manufacturing practice for methods to be used
in, and the facilities or controls to be used for, the manufacture, processing,
packing, or holding of a drug to assure that such drug meets the requirements
of the act as to safety, and has the identity and strength and meets the
quality and purity characteristics that it purports or is represented to
possess.
(b) The failure to comply with any regulation set forth in this
part and in Parts 211 through 226 of this chapter in the manufacture,
processing, packing, or holding of a drug shall render such drug to be
adulterated under section 501(a)(2)(B) of the act and such drug, as well as the
person who is responsible for the failure to comply, shall be subject to
regulatory action.
§ 210.2 Applicability of current good manufacturing practice
regulations.
(a) The regulations in this part and in Parts 211 through 226 of
this chapter as they may pertain to a drug and in Parts 600 through 680 of this
chapter as they may pertain to a biological product for human use, shall be
considered to supplement, not supersede, each other, unless the regulations
explicitly provide otherwise. In the event that it is impossible to comply with
all applicable regulations in these parts, the regulations specifically
applicable to the drug in question shall supersede the more general.
(b) If a person engages in only some operations subject to the
regulations in this part and in Parts through 226 and Parts 600 through 680 of
this chapter, and not in others, that person need only
comply
with those regulations applicable to the operations in which he or she is
engaged.
§
210.3 Definitions.
(a)
The definitions and interpretations contained in section 201 of the act shall
be applicable to such terms when used in this part and in Parts 211 through 226
of this chapter.
(b)
The following definitions of terms apply to this part and to Parts 211 through
226 of this chapter.
(1)
Act means the Federal Food, Drug, and Cosmetic Act, as amended (21
U.S.C. 301 et seq.).
(2)
Batch means a specific quantity of a drug or other material that is
intended to have uniform
character
and quality, within specified limits, and is produced according to a single
manufacturing order during the same cycle of manufacture.
(3)
Component means any ingredient intended for use in the manufacture of a
drug product, including those that may not appear in such drug product.
(4)
Drug product means a finished dosage form, for example, tablet, capsule,
solution, etc., that
contains
an active drug ingredient generally, but not necessarily, in association with
inactive ingredients. The term also includes a finished dosage form that does
not contain an active ingredient but is intended to be used as a placebo.
(5)
Fiber means any particulate contaminant with a length at least three
times greater than its width.
(6)
Non-fiber-releasing filter means any filter, which after any appropriate
pretreatment such as
washing
or flushing, will not release fibers into the component or drug product that is
being filtered. All filters composed of asbestos are deemed to be
fiber-releasing filters.
(7)
Active ingredient means any component that is intended to furnish
pharmacological activity or other direct effect in the diagnosis, cure,
mitigation, treatment, or prevention of disease, or to affect the structure or
any function of the body of man or other animals. The term includes those
components
that may undergo chemical change in the manufacture of the drug product and be
present in the drug product in a modified form intended to furnish the
specified activity or effect.
(8)
Inactive ingredient means any component other than an ``active
ingredient.''
(9)
In-process material means any material fabricated, compounded, blended,
or derived by chemical reaction that is produced for, and used in, the
preparation of the drug product.
(10)
Lot means a batch, or a specific identified portion of a batch, having
uniform character and
quality
within specified limits; or, in the case of a drug product produced by
continuous process, it is a specific identified amount produced in a unit of
time or quantity in a manner that assures its having uniform character and
quality within specified limits.
(11)
Lot number, control number, or batch number means any distinctive
combination of letters,
numbers,
or symbols, or any combination of them, from which the complete history of the
manufacture, processing, packing, holding, and distribution of a batch or lot
of drug product or other material can be determined.
(12)
Manufacture, processing, packing, or holding of a drug product includes
packaging and labeling operations, testing, and quality control of drug
products.
(13)
The term medicated feed means any Type B or Type C medicated feed as
defined in 558.3 of this chapter. The feed contains one or more drugs as
defined in section 201(g) of the act. The manufacture of medicated feeds is subject
to the requirements of Part 225 of this chapter.
(14)
The term medicated premix means a Type A medicated article as defined in
558.3 of this chapter. The article contains one or more drugs as defined in
section 201(g) of the act. The manufacture of medicated premixes is subject to
the requirements of Part 226 of this chapter.
(15)
Quality control unit means any person or organizational element
designated by the firm to be responsible for the duties relating to quality
control.
(16)
Strength means:
(I)
The concentration of the drug substance (for example, weight/weight,
weight/volume, or unit
dose/volume
basis), and/or
(ii)
The potency, that is, the therapeutic activity of the drug product as indicated
by appropriate
laboratory
tests or by adequately developed and controlled clinical data (expressed, for
example, in terms of units by reference to a standard).
(17)
Theoretical yield means the quantity that would be produced at any
appropriate phase of
manufacture,
processing, or packing of a particular drug product, based upon the quantity of
components
to be used, in the absence of any loss or error in actual production.
(18)
Actual yield means the quantity that is actually produced at any
appropriate phase of
manufacture,
processing, or packing of a particular drug product.
(19)
Percentage of theoretical yield means the ratio of the actual yield (at
any appropriate phase of manufacture, processing, or packing of a particular
drug product) to the theoretical yield (at the same phase), stated as a percentage.
(20)
Acceptance criteria means the product specifications and
acceptance/rejection criteria, such as acceptable quality level and
unacceptable quality level, with an associated sampling plan, that are
necessary for making a decision to accept or reject a lot or batch (or any
other convenient subgroups of manufactured units).
(21)
Representative sample means a sample that consists of a number of units
that are drawn based on rational criteria such as random sampling and intended
to assure that the sample accurately portrays the material being sampled.
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