[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: 21CFR111.30]

[Page 236]
 
                        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 D_Equipment and Utensils
 
Sec.  111.30  What requirements apply to automated, mechanical, or electronic equipment?

    For any automated, mechanical, or electronic equipment that you use 
to manufacture, package, label, or hold a dietary supplement, you must:
    (a) Design or select equipment to ensure that dietary supplement 
specifications are consistently met;
    (b) Determine the suitability of the equipment by ensuring that your 
equipment is capable of operating satisfactorily within the operating 
limits required by the process;
    (c) Routinely calibrate, inspect, or check the equipment to ensure 
proper performance. Your quality control personnel must periodically 
review these calibrations, inspections, or checks;
    (d) Establish and use appropriate controls for automated, 
mechanical, and electronic equipment (including software for a computer 
controlled process) to ensure that any changes to the manufacturing, 
packaging, labeling, holding, or other operations are approved by 
quality control personnel and instituted only by authorized personnel; 
and
    (e) Establish and use appropriate controls to ensure that the 
equipment functions in accordance with its intended use. These controls 
must be approved by quality control personnel.