[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: 21CFR211.105]

[Page 123]
 
                        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 F--Production and Process Controls
 
Sec. 211.105  Equipment identification.

    (a) All compounding and storage containers, processing lines, and 
major equipment used during the production of a batch of a drug product 
shall be properly identified at all times to indicate their contents 
and, when necessary, the phase of processing of the batch.
    (b) Major equipment shall be identified by a distinctive 
identification number or code that shall be recorded in the batch 
production record to show the specific equipment used in the manufacture 
of each batch of a drug product. In cases where only one of a particular 
type of equipment exists in a manufacturing facility, the name of the 
equipment may be used in lieu of a distinctive identification number or 
code.