C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER C—DRUGS: GENERAL › PART 211—CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS › Subpart C—Buildings and Facilities

21 C.F.R. § 211.42

Design and construction features

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(a) Any building or buildings used in the manufacture, processing, packing, or holding of a drug product shall be of suitable size, construction and location to facilitate cleaning, maintenance, and proper operations.

(b) Any such building shall have adequate space for the orderly placement of equipment and materials to prevent mixups between different components, drug product containers, closures, labeling, in-process materials, or drug products, and to prevent contamination. The flow of components, drug product containers, closures, labeling, in-process materials, and drug products through the building or buildings shall be designed to prevent contamination.

(c) Operations shall be performed within specifically defined areas of adequate size. There shall be separate or defined areas or such other control systems for the firm's operations as are necessary to prevent contamination or mixups during the course of the following procedures:

(1) Receipt, identification, storage, and withholding from use of components, drug product containers, closures, and labeling, pending the appropriate sampling, testing, or examination by the quality control unit before release for manufacturing or packaging;

(2) Holding rejected components, drug product containers, closures, and labeling before disposition;

(3) Storage of released components, drug product containers, closures, and labeling;

(4) Storage of in-process materials;

(5) Manufacturing and processing operations;

(6) Packaging and labeling operations;

(7) Quarantine storage before release of drug products;

(8) Storage of drug products after release;

(9) Control and laboratory operations;

(10) Aseptic processing, which includes as appropriate:

(i) Floors, walls, and ceilings of smooth, hard surfaces that are easily cleanable;

(ii) Temperature and humidity controls;

(iii) An air supply filtered through high-efficiency particulate air filters under positive pressure, regardless of whether flow is laminar or nonlaminar;

(iv) A system for monitoring environmental conditions;

(v) A system for cleaning and disinfecting the room and equipment to produce aseptic conditions;

(vi) A system for maintaining any equipment used to control the aseptic conditions.

(d) Operations relating to the manufacture, processing, and packing of penicillin shall be performed in facilities separate from those used for other drug products for human use.

[43 FR 45077, Sept. 29, 1978, as amended at 60 FR 4091, Jan. 20, 1995]
Notes of Decisions
Cited in 5 cases, 1980–2014 · leading case: US ex rel. Barry Rostholder v. Omnicare, Inc., 745 F.3d 694 (4th Cir. 2014).
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US ex rel. Barry Rostholder v. Omnicare, Inc., 745 F.3d 694 (4th Cir. 2014). “21 C.F.R. §§ 211.42 , 211.46(d). The regulations require that non-penicillin drugs be tested for the presence of penicillin “[i]f a reasonable possibility exists” that the non-penicillin drug has been exposed to penicillin cross-contamination.”
John D. Copanos & Sons, Inc. & Kanasco, Ltd. v. Food & Drug Admin. & Frank E. Young, M.D., ph.d., Comm'r of Food & Drugs, 854 F.2d 510 (D.C. Cir. 1988). “at 7315; see also 21 C.F.R. § 211.42 (d) (“Operations relating to the manufacture, processing, and packing of penicillin shall be performed in facilities separate from those used for other drug products for human use.”
United States v. Richlyn Labs., Inc., 827 F. Supp. 1145 (E.D. Pa. 1992). “” 21 C.F.R. § 211.42 . Adequate ventilation is to be provided and air filtration systems are to be used when appropriate on air supplies to production areas.”
United States v. W. Serum Co., Inc., 498 F. Supp. 863 (D. Ariz. 1980). “21 C.F.R. § 211.42 (d); see id. § 211.58(e).”
United States v. Richlyn Labs., Inc., 822 F. Supp. 268 (E.D. Pa. 1993). “” 21 C.F.R. § 211.42 . Adequate ventilation is to be provided and air filtration systems are to be used when appropriate on air supplies to production areas.”
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