1. Pt. 210 21 CFR Ch. I (4–1–11 Edition)
PART 210—CURRENT GOOD MAN- tion to the regulations in this part and
UFACTURING PRACTICE IN MAN- in parts 211 through 226 of this chapter.
UFACTURING, PROCESSING, Failure to comply with any applicable
regulation set forth in this part, in
PACKING, OR HOLDING OF parts 211 through 226 of this chapter, in
DRUGS; GENERAL part 1271 subpart C of this chapter, or
in part 1271 subpart D of this chapter
Sec. with respect to the manufacture, proc-
210.1 Status of current good manufacturing
practice regulations.
essing, packing or holding of a drug,
210.2 Applicability of current good manu- renders an HCT/P adulterated under
facturing practice regulations. section 501(a)(2)(B) of the act. Such
210.3 Definitions. HCT/P, as well as the person who is re-
AUTHORITY: 21 U.S.C. 321, 351, 352, 355, 360b, sponsible for the failure to comply, is
371, 374; 42 U.S.C. 216, 262, 263a, 264. subject to regulatory action.
SOURCE: 43 FR 45076, Sept, 29, 1978, unless [43 FR 45076, Sept, 29, 1978, as amended at 69
otherwise noted. FR 29828, May 25, 2004]
EFFECTIVE DATE NOTE: At 74 FR 65431, Dec.
§ 210.1 Status of current good manu- 10, 2009, § 210.1 was amended by removing the
facturing practice regulations. phrase ‘‘211 through 226’’ each time it ap-
(a) The regulations set forth in this pears and by adding in its place the phrase
part and in parts 211 through 226 of this ‘‘211, 225, and 226’’, effective Dec. 12, 2011.
chapter contain the minimum current
good manufacturing practice for meth- § 210.2 Applicability of current good
manufacturing practice regulations.
ods to be used in, and the facilities or
controls to be used for, the manufac- (a) The regulations in this part and
ture, processing, packing, or holding of in parts 211 through 226 of this chapter
a drug to assure that such drug meets as they may pertain to a drug; in parts
the requirements of the act as to safe- 600 through 680 of this chapter as they
ty, and has the identity and strength may pertain to a biological product for
and meets the quality and purity char- human use; and in part 1271 of this
acteristics that it purports or is rep- chapter as they are applicable to a
resented to possess. human cell, tissue, or cellular or tis-
(b) The failure to comply with any sue-based product (HCT/P) that is a
regulation set forth in this part and in drug (subject to review under an appli-
parts 211 through 226 of this chapter in cation submitted under section 505 of
the manufacture, processing, packing, the act or under a biological product li-
or holding of a drug shall render such cense application under section 351 of
drug to be adulterated under section the Public Health Service Act); shall
501(a)(2)(B) of the act and such drug, as be considered to supplement, not super-
well as the person who is responsible sede, each other, unless the regulations
for the failure to comply, shall be sub- explicitly provide otherwise. In the
ject to regulatory action. event of a conflict between applicable
(c) Owners and operators of establish- regulations in this part and in other
ments engaged in the recovery, donor parts of this chapter, the regulation
screening, testing (including donor specifically applicable to the drug
testing), processing, storage, labeling, product in question shall supersede the
packaging, or distribution of human more general.
cells, tissues, and cellular and tissue- (b) If a person engages in only some
based products (HCT/Ps), as defined in operations subject to the regulations in
§ 1271.3(d) of this chapter, that are this part, in parts 211 through 226 of
drugs (subject to review under an appli- this chapter, in parts 600 through 680 of
cation submitted under section 505 of this chapter, and in part 1271 of this
the act or under a biological product li- chapter, and not in others, that person
cense application under section 351 of need only comply with those regula-
the Public Health Service Act), are tions applicable to the operations in
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subject to the donor-eligibility and ap- which he or she is engaged.
plicable current good tissue practice (c) An investigational drug for use in
procedures set forth in part 1271 sub- a phase 1 study, as described in
parts C and D of this chapter, in addi- § 312.21(a) of this chapter, is subject to
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2. Food and Drug Administration, HHS § 210.3
the statutory requirements set forth in (5) Fiber means any particulate con-
21 U.S.C. 351(a)(2)(B). The production of taminant with a length at least three
such drug is exempt from compliance times greater than its width.
with the regulations in part 211 of this (6) Nonfiber releasing filter means any
chapter. However, this exemption does filter, which after appropriate
not apply to an investigational drug pretreatment such as washing or flush-
for use in a phase 1 study once the in- ing, will not release fibers into the
vestigational drug has been made component or drug product that is
available for use by or for the sponsor being filtered.
in a phase 2 or phase 3 study, as de- (7) Active ingredient means any com-
scribed in § 312.21(b) and (c) of this ponent that is intended to furnish
chapter, or the drug has been lawfully pharmacological activity or other di-
marketed. If the investigational drug rect effect in the diagnosis, cure, miti-
has been made available in a phase 2 or gation, treatment, or prevention of dis-
phase 3 study or the drug has been law- ease, or to affect the structure or any
fully marketed, the drug for use in the function of the body of man or other
phase 1 study must comply with part animals. The term includes those com-
211. ponents that may undergo chemical
[69 FR 29828, May 25, 2004, as amended at 73 change in the manufacture of the drug
FR 40462, July 15, 2008] product and be present in the drug
EFFECTIVE DATE NOTE: At 74 FR 65431, Dec. product in a modified form intended to
10, 2009, § 210.2(a) and (b) were amended by re- furnish the specified activity or effect.
moving the phrase ‘‘211 through 226’’ both (8) Inactive ingredient means any com-
times it appears and by adding in its place ponent other than an active ingredient.
the phrase ‘‘211, 225, and 226’’, effective Dec.
(9) In-process material means any ma-
12, 2011.
terial fabricated, compounded, blended,
§ 210.3 Definitions. or derived by chemical reaction that is
produced for, and used in, the prepara-
(a) The definitions and interpreta-
tion of the drug product.
tions contained in section 201 of the act
shall be applicable to such terms when (10) Lot means a batch, or a specific
used in this part and in parts 211 identified portion of a batch, having
through 226 of this chapter. uniform character and quality within
(b) The following definitions of terms specified limits; or, in the case of a
apply to this part and to parts 211 drug product produced by continuous
through 226 of this chapter. process, it is a specific identified
(1) Act means the Federal Food, Drug, amount produced in a unit of time or
and Cosmetic Act, as amended (21 quantity in a manner that assures its
U.S.C. 301 et seq.). having uniform character and quality
(2) Batch means a specific quantity of within specified limits.
a drug or other material that is in- (11) Lot number, control number, or
tended to have uniform character and batch number means any distinctive
quality, within specified limits, and is combination of letters, numbers, or
produced according to a single manu- symbols, or any combination of them,
facturing order during the same cycle from which the complete history of the
of manufacture. manufacture, processing, packing,
(3) Component means any ingredient holding, and distribution of a batch or
intended for use in the manufacture of lot of drug product or other material
a drug product, including those that can be determined.
may not appear in such drug product. (12) Manufacture, processing, packing,
(4) Drug product means a finished dos- or holding of a drug product includes
age form, for example, tablet, capsule, packaging and labeling operations,
solution, etc., that contains an active testing, and quality control of drug
drug ingredient generally, but not nec- products.
essarily, in association with inactive (13) The term medicated feed means
WReier-Aviles on DSKGBLS3C1PROD with CFR
ingredients. The term also includes a any Type B or Type C medicated feed
finished dosage form that does not con- as defined in § 558.3 of this chapter. The
tain an active ingredient but is in- feed contains one or more drugs as de-
tended to be used as a placebo. fined in section 201(g) of the act. The
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3. Pt. 211 21 CFR Ch. I (4–1–11 Edition)
manufacture of medicated feeds is sub- units that are drawn based on rational
ject to the requirements of part 225 of criteria such as random sampling and
this chapter. intended to assure that the sample ac-
(14) The term medicated premix means curately portrays the material being
a Type A medicated article as defined sampled.
in § 558.3 of this chapter. The article (22) Gang-printed labeling means la-
contains one or more drugs as defined beling derived from a sheet of material
in section 201(g) of the act. The manu- on which more than one item of label-
facture of medicated premixes is sub- ing is printed.
ject to the requirements of part 226 of
[43 FR 45076, Sept. 29, 1978, as amended at 51
this chapter. FR 7389, Mar. 3, 1986; 58 FR 41353, Aug. 3, 1993;
(15) Quality control unit means any 73 FR 51931, Sept. 8, 2008]
person or organizational element des-
ignated by the firm to be responsible EFFECTIVE DATE NOTE: At 74 FR 65431, Dec.
10, 2009, § 210.3(a) and (b) introductory text
for the duties relating to quality con- were amended by removing the phrase ‘‘211
trol. through 226’’ and adding in its place the
(16) Strength means: phrase ‘‘211, 225, and 226’’, effective Dec. 12,
(i) The concentration of the drug sub- 2011.
stance (for example, weight/weight,
weight/volume, or unit dose/volume PART 211—CURRENT GOOD MAN-
basis), and/or
(ii) The potency, that is, the thera-
UFACTURING PRACTICE FOR FIN-
peutic activity of the drug product as ISHED PHARMACEUTICALS
indicated by appropriate laboratory
tests or by adequately developed and Subpart A—General Provisions
controlled clinical data (expressed, for Sec.
example, in terms of units by reference 211.1 Scope.
to a standard). 211.3 Definitions.
(17) Theoretical yield means the quan-
tity that would be produced at any ap- Subpart B—Organization and Personnel
propriate phase of manufacture, proc- 211.22 Responsibilities of quality control
essing, or packing of a particular drug unit.
product, based upon the quantity of 211.25 Personnel qualifications.
components to be used, in the absence 211.28 Personnel responsibilities.
of any loss or error in actual produc- 211.34 Consultants.
tion.
(18) Actual yield means the quantity Subpart C—Buildings and Facilities
that is actually produced at any appro-
211.42 Design and construction features.
priate phase of manufacture, proc- 211.44 Lighting.
essing, or packing of a particular drug 211.46 Ventilation, air filtration, air heating
product. and cooling.
(19) Percentage of theoretical yield 211.48 Plumbing.
means the ratio of the actual yield (at 211.50 Sewage and refuse.
any appropriate phase of manufacture, 211.52 Washing and toilet facilities.
processing, or packing of a particular 211.56 Sanitation.
drug product) to the theoretical yield 211.58 Maintenance.
(at the same phase), stated as a per-
centage. Subpart D—Equipment
(20) Acceptance criteria means the 211.63 Equipment design, size, and location.
product specifications and acceptance/ 211.65 Equipment construction.
rejection criteria, such as acceptable 211.67 Equipment cleaning and mainte-
quality level and unacceptable quality nance.
level, with an associated sampling 211.68 Automatic, mechanical, and elec-
plan, that are necessary for making a tronic equipment.
decision to accept or reject a lot or 211.72 Filters.
WReier-Aviles on DSKGBLS3C1PROD with CFR
batch (or any other convenient sub- Subpart E—Control of Components and
groups of manufactured units). Drug Product Containers and Closures
(21) Representative sample means a
sample that consists of a number of 211.80 General requirements.
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