[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR211.68]

[Page 121]
 
                        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--Table of Contents
 
                          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 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]