Food and Drug Administration, HHS
`
`and meets the quality and purity char-
`acteristics that it purports or is rep-
`resented 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 sub-
`ject to regulatory action.
`(c) Owners and operators of establish-
`ments 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 appli-
`cation submitted under section 505 of
`the act or under a biological product li-
`cense application under section 351 of
`the Public Health Service Act), are
`subject to the donor-eligibility and ap-
`plicable current good tissue practice
`procedures set forth in part 1271 sub-
`parts C and D of this chapter, in addi-
`tion to the regulations in this part and
`in parts 211 through 226 of this chapter.
`Failure to comply with any applicable
`regulation set forth in this part, in
`parts 211 through 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, proc-
`essing, 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 re-
`sponsible 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]
`
`§ 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; 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 tis-
`sue-based product (HCT/P) that is a
`drug (subject to review under an appli-
`
`§ 210.3
`
`cation submitted under section 505 of
`the act or under a biological product li-
`cense application under section 351 of
`the Public Health Service Act); shall
`be considered to supplement, not super-
`sede, 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 through 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 regula-
`tions applicable to the operations in
`which he or she is engaged.
`
`[69 FR 29828, May 25, 2004]
`
`§ 210.3 Definitions.
`(a) The definitions and interpreta-
`tions 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 in-
`tended to have uniform character and
`quality, within specified limits, and is
`produced according to a single manu-
`facturing 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 dos-
`age form, for example, tablet, capsule,
`solution, etc., that contains an active
`drug ingredient generally, but not nec-
`essarily, in association with inactive
`ingredients. The term also includes a
`finished dosage form that does not con-
`tain an active ingredient but is in-
`tended to be used as a placebo.
`(5) Fiber means any particulate con-
`taminant with a length at least three
`times greater than its width.
`
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`§ 210.3
`
`(6) Non-fiber-releasing filter means any
`filter, which after any appropriate
`pretreatment such as washing or flush-
`ing, will not release fibers into the
`component or drug product that is
`being filtered. All filters composed of
`asbestos are deemed to be fiber-releas-
`ing filters.
`(7) Active ingredient means any com-
`ponent that is intended to furnish
`pharmacological activity or other di-
`rect effect in the diagnosis, cure, miti-
`gation, treatment, or prevention of dis-
`ease, or to affect the structure or any
`function of the body of man or other
`animals. The term includes those com-
`ponents 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 com-
`ponent other than an active ingredient.
`(9) In-process material means any ma-
`terial fabricated, compounded, blended,
`or derived by chemical reaction that is
`produced for, and used in, the prepara-
`tion 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 de-
`fined in section 201(g) of the act. The
`manufacture of medicated feeds is sub-
`
`21 CFR Ch. I (4–1–07 Edition)
`
`ject 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 manu-
`facture of medicated premixes is sub-
`ject to the requirements of part 226 of
`this chapter.
`(15) Quality control unit means any
`person or organizational element des-
`ignated by the firm to be responsible
`for the duties relating to quality con-
`trol.
`(16) Strength means:
`(i) The concentration of the drug sub-
`stance (for example, weight/weight,
`weight/volume, or unit dose/volume
`basis), and/or
`(ii) The potency, that is, the thera-
`peutic 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 quan-
`tity that would be produced at any ap-
`propriate phase of manufacture, proc-
`essing, 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 produc-
`tion.
`(18) Actual yield means the quantity
`that is actually produced at any appro-
`priate phase of manufacture, proc-
`essing, 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 per-
`centage.
`(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 sub-
`groups of manufactured units).
`(21) Representative sample means a
`sample that consists of a number of
`units that are drawn based on rational
`
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`Pt. 211
`
`211.89 Rejected components, drug product
`containers, and closures.
`211.94 Drug product containers and closures.
`
`Subpart F—Production and Process
`Controls
`
`211.100 Written procedures; deviations.
`211.101 Charge-in of components.
`211.103 Calculation of yield.
`211.105 Equipment identification.
`211.110 Sampling and testing of in-process
`materials and drug products.
`211.111 Time limitations on production.
`211.113 Control of microbiological contami-
`nation.
`211.115 Reproccessing.
`
`Subpart G—Packaging and Labeling
`Control
`
`211.122 Materials examination and usage
`criteria.
`211.125 Labeling issuance.
`211.130 Packaging and labeling operations.
`211.132 Tamper-evident packaging require-
`ments for over-the-counter (OTC) human
`drug products.
`211.134 Drug product inspection.
`211.137 Expiration dating.
`
`Subpart H—Holding and Distribution
`
`211.142 Warehousing procedures.
`211.150 Distribution procedures.
`
`Subpart I—Laboratory Controls
`
`211.160 General requirements.
`211.165 Testing and release for distribution.
`211.166 Stability testing.
`211.167 Special testing requirements.
`211.170 Reserve samples.
`211.173 Laboratory animals.
`211.176 Penicillin contamination.
`
`Subpart J—Records and Reports
`
`control
`
`211.180 General requirements.
`211.182 Equipment cleaning and use log.
`211.184 Component, drug product container,
`closure, and labeling records.
`211.186 Master production and
`records.
`211.188 Batch
`records.
`211.192 Production record review.
`211.194 Laboratory records.
`211.196 Distribution records.
`211.198 Complaint files.
`
`production
`
`and
`
`control
`
`Food and Drug Administration, HHS
`
`criteria such as random sampling and
`intended to assure that the sample ac-
`curately portrays the material being
`sampled.
`(22) Gang-printed labeling means la-
`beling derived from a sheet of material
`on which more than one item of label-
`ing is printed.
`
`[43 FR 45076, Sept. 29, 1978, as amended at 51
`FR 7389, Mar. 3, 1986; 58 FR 41353, Aug. 3, 1993]
`
`PART 211—CURRENT GOOD MAN-
`UFACTURING PRACTICE FOR FIN-
`ISHED PHARMACEUTICALS
`
`Subpart A—General Provisions
`
`Sec.
`211.1 Scope.
`211.3 Definitions.
`
`Subpart B—Organization and Personnel
`
`211.22 Responsibilities of quality control
`unit.
`211.25 Personnel qualifications.
`211.28 Personnel responsibilities.
`211.34 Consultants.
`
`Subpart C—Buildings and Facilities
`
`211.42 Design and construction features.
`211.44 Lighting.
`211.46 Ventilation, air filtration, air heating
`and cooling.
`211.48 Plumbing.
`211.50 Sewage and refuse.
`211.52 Washing and toilet facilities.
`211.56 Sanitation.
`211.58 Maintenance.
`
`Subpart D—Equipment
`
`211.63 Equipment design, size, and location.
`211.65 Equipment construction.
`211.67 Equipment cleaning and mainte-
`nance.
`211.68 Automatic, mechanical, and elec-
`tronic equipment.
`211.72 Filters.
`
`Subpart E—Control of Components and
`Drug Product Containers and Closures
`
`211.80 General requirements.
`211.82 Receipt and storage of untested com-
`ponents, drug product containers, and
`closures.
`211.84 Testing and approval or rejection of
`components, drug product containers,
`and closures.
`211.86 Use of approved components, drug
`product containers, and closures.
`211.87 Retesting of approved components,
`drug product containers, and closures.
`
`Subpart K—Returned and Salvaged Drug
`Products
`
`211.204 Returned drug products.
`211.208 Drug product salvaging.
`AUTHORITY: 21 U.S.C. 321, 351, 352, 355, 360b,
`371, 374; 42 U.S.C. 216, 262, 263a, 264.
`
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