[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR210.3]

[Page 115-116]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 210--CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL--Table of Contents
 
 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 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

[[Page 116]]

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 Sec. 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 Sec. 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]