[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: 21CFR111.35]

[Page 236-237]
 
                        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.  111.35  Under this subpart D, what records must you make and keep?

    (a) You must make and keep records required under this subpart D in 
accordance with subpart P of this part.
    (b) You must make and keep the following records:
    (1) Written procedures for fulfilling the requirements of this 
subpart, including written procedures for:
    (i) Calibrating instruments and controls that you use in 
manufacturing or testing a component or dietary supplement;
    (ii) Calibrating, inspecting, and checking automated, mechanical, 
and electronic equipment; and
    (iii) Maintaining, cleaning, and sanitizing, as necessary, all 
equipment, utensils, and any other contact surfaces that are used to 
manufacture, package, label, or hold components or dietary supplements;
    (2) Documentation, in individual equipment logs, of the date of the 
use, maintenance, cleaning, and sanitizing of equipment, unless such 
documentation is kept with the batch record;
    (3) Documentation of any calibration, each time the calibration is 
performed, for instruments and controls that you use in manufacturing or 
testing a component or dietary supplement. In your documentation, you 
must:
    (i) Identify the instrument or control calibrated;
    (ii) Provide the date of calibration;
    (iii) Identify the reference standard used including the 
certification of accuracy of the known reference standard and a history 
of recertification of accuracy;
    (iv) Identify the calibration method used, including appropriate 
limits for accuracy and precision of instruments and controls when 
calibrating;
    (v) Provide the calibration reading or readings found;
    (vi) Identify the recalibration method used, and reading or readings 
found, if accuracy or precision or both accuracy and precision limits 
for instruments and controls were not met; and
    (vii) Include the initials of the person who performed the 
calibration and any recalibration.
    (4) Written records of calibrations, inspections, and checks of 
automated, mechanical, and electronic equipment;

[[Page 237]]

    (5) Backup file(s) of current software programs (and of outdated 
software that is necessary to retrieve records that you are required to 
keep in accordance with subpart P of this part, when current software is 
not able to retrieve such records) and of data entered into computer 
systems that you use to manufacture, package, label, or hold dietary 
supplements.
    (i) Your backup file (e.g., a hard copy of data you have entered, 
diskettes, tapes, microfilm, or compact disks) must be an exact and 
complete record of the data you entered.
    (ii) You must keep your backup software programs and data secure 
from alterations, inadvertent erasures, or loss; and
    (6) Documentation of the controls that you use to ensure that 
equipment functions in accordance with its intended use.