[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR111.117]

[Page 243]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 111_CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS--Table of Contents
 
   Subpart F_Production and Process Control System: Requirements for 
                             Quality Control
 
Sec.  111.117  What quality control operations are required for equipment, instruments, and controls?

    Quality control operations for equipment, instruments, and controls 
must include:
    (a) Reviewing and approving all processes for calibrating 
instruments and controls;
    (b) Periodically reviewing all records for calibration of 
instruments and controls;
    (c) Periodically reviewing all records for calibrations, 
inspections, and checks of automated, mechanical, or electronic 
equipment; and
    (d) Reviewing and approving controls to ensure that automated, 
mechanical, or electronic equipment functions in accordance with its 
intended use.