[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR211.67]

[Page 139]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 211_CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS--
 
                           Subpart D_Equipment
 
Sec.  211.67  Equipment cleaning and maintenance.

    (a) Equipment and utensils shall be cleaned, maintained, and 
sanitized at appropriate intervals to prevent malfunctions or 
contamination that would alter the safety, identity, strength, quality, 
or purity of the drug product beyond the official or other established 
requirements.
    (b) Written procedures shall be established and followed for 
cleaning and maintenance of equipment, including utensils, used in the 
manufacture, processing, packing, or holding of a drug product. These 
procedures shall include, but are not necessarily limited to, the 
following:
    (1) Assignment of responsibility for cleaning and maintaining 
equipment;
    (2) Maintenance and cleaning schedules, including, where 
appropriate, sanitizing schedules;
    (3) A description in sufficient detail of the methods, equipment, 
and materials used in cleaning and maintenance operations, and the 
methods of disassembling and reassembling equipment as necessary to 
assure proper cleaning and maintenance;
    (4) Removal or obliteration of previous batch identification;
    (5) Protection of clean equipment from contamination prior to use;
    (6) Inspection of equipment for cleanliness immediately before use.
    (c) Records shall be kept of maintenance, cleaning, sanitizing, and 
inspection as specified in Sec. Sec.  211.180 and 211.182.