Definitions as per 21 CFR 210 (USFDA) in Pharma company
(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 for Pharma company.
(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.
(22) Gang-printed labeling means labeling derived from a sheet of material on which more than one
item of labeling is printed.
Reference – 21 CODE OF FEDERAL REGULATIONS – Part 210 & 211
Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field.
During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube