[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR211.42]

[Page 118]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 211--CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS--Table of Contents
 
                   Subpart C--Buildings and Facilities
 
Sec. 211.42  Design and construction features.


    (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]