[Code of Federal Regulations]

[Title 21, Volume 4]

[Revised as of April 1, 2015]
[CITE: 21CFR210]

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER C--DRUGS: GENERAL
PART 210 CURRENT GOOD MANUFACTURING PRACTICE IN
  MANUFACTURING, PROCESSING, PACKING, OR  
HOLDING OF DRUGS; GENERAL

Sec. 210.1 Status of current good manufacturing practice regulations.

(a) The regulations set forth in this part and in parts 211, 225, and 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, 225, and 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.

(c) Owners and operators of establishments engaged in the recovery, donor

screening, testing (including donor testing), processing, storage, labeling,
packaging, or distribution of human cells, tissues, and cellular and tissue-
based products (HCT/Ps), as defined in 1271.3(d) of this chapter, that are
drugs (subject to review under an application submitted under section 505 of
the act or under a biological product license application under section 351
of the Public Health Service Act), are subject to the donor-eligibility and
applicable current good tissue practice procedures set forth in part 1271
subparts C and D of this chapter, in addition to the regulations in this
part and in parts 211, 225, and 226 of this chapter. Failure to comply with
any applicable regulation set forth in this part, in parts 211, 225, and 226
of this chapter, in part 1271 subpart C of this chapter, or in part 1271
subpart D of this chapter with respect to the manufacture, processing,
packing or holding of a drug, renders an HCT/P adulterated under section
501(a)(2)(B) of the act. Such HCT/P, as well as the person who is
responsible for the failure to comply, is subject to regulatory action.

[43 FR 45076, Sept. 29, 1978, as amended at 69 FR 29828, May 25, 2004; 74 FR
65431, Dec. 10, 2009]

Sec. 210.2 Applicability of current good manufacturing practice regulations.

(a) The regulations in this part and in parts 211, 225, and 226 of this
chapter as they may pertain to a drug; in parts 600 through 680 of this
chapter as they may pertain to a biological product for human use; and in
part 1271 of this chapter as they are applicable to a human cell, tissue, or
cellular or tissue-based product (HCT/P) that is a drug (subject to review
under an application submitted under section 505 of the act or under a
biological product license application under section 351 of the Public
Health Service Act); shall be considered to supplement, not supersede, each
other, unless the regulations explicitly provide otherwise. In the event of
a conflict between applicable regulations in this part and in other parts of
this chapter, the regulation specifically applicable to the drug product in
question shall supersede the more general.

(b) If a person engages in only some operations subject to the regulations

in this part, in parts 211, 225, and 226 of this chapter, in parts 600
through 680 of this chapter, and in part 1271 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.

(c) An investigational drug for use in a phase 1 study, as described in

312.21(a) of this chapter, is subject to the statutory requirements set
forth in 21 U.S.C. 351(a)(2)(B). The production of such drug is exempt from
compliance with the regulations in part 211 of this chapter. However, this
exemption does not apply to an investigational drug for use in a phase 1
study once the investigational drug has been made available for use by or
for the sponsor in a phase 2 or phase 3 study, as described in 312.21(b) and
(c) of this chapter, or the drug has been lawfully marketed. If the
investigational drug has been made available in a phase 2 or phase 3 study
or the drug has been lawfully marketed, the drug for use in the phase 1
study must comply with part 211.

[69 FR 29828, May 25, 2004, as amended at 73 FR 40462, July 15, 2008; 74 FR
65431, Dec. 10, 2009]

Sec. 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,
225, and 226 of this chapter.

(b) The following definitions of terms apply to this part and to parts 211,
225, and 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) Nonfiber releasing filter means any filter, which after appropriate
pretreatment such as washing or flushing, will not release fibers into the
component or drug product that is being filtered.

(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.

(22) Gang-printed labeling means labeling derived from a sheet of material

on which more than one item of labeling is printed.

[43 FR 45076, Sept. 29, 1978, as amended at 51 FR 7389, Mar. 3, 1986; 58 FR

41353, Aug. 3, 1993; 73 FR 51931, Sept. 8, 2008; 74 FR 65431, Dec. 10, 2009]

Authority: 21 U.S.C. 321, 351, 352, 355, 360b, 371, 374; 42 U.S.C. 216, 262,
263a, 264.
Source: 43 FR 45076, Sept, 29, 1978, unless otherwise noted.