[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: 21CFR211.68]

[Page 139-140]
 
                        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.  211.68  Automatic, mechanical, and electronic equipment.

    (a) Automatic, mechanical, or electronic equipment or other types of 
equipment, including computers, or related systems that will perform a 
function satisfactorily, may be used in the manufacture, processing, 
packing, and holding of a drug product. If such equipment is so used, it 
shall be routinely calibrated, inspected, or checked according to a 
written program designed to assure proper performance. Written records 
of those calibration checks and inspections shall be maintained.
    (b) Appropriate controls shall be exercised over computer or related 
systems to assure that changes in master

[[Page 140]]

production and control records or other records are instituted only by 
authorized personnel. Input to and output from the computer or related 
system of formulas or other records or data shall be checked for 
accuracy. The degree and frequency of input/output verification shall be 
based on the complexity and reliability of the computer or related 
system. A backup file of data entered into the computer or related 
system shall be maintained except where certain data, such as 
calculations performed in connection with laboratory analysis, are 
eliminated by computerization or other automated processes. In such 
instances a written record of the program shall be maintained along with 
appropriate validation data. Hard copy or alternative systems, such as 
duplicates, tapes, or microfilm, designed to assure that backup data are 
exact and complete and that it is secure from alteration, inadvertent 
erasures, or loss shall be maintained.

[43 FR 45077, Sept. 29, 1978, as amended at 60 FR 4091, Jan. 20, 1995]