---
kind: "section"
citation: "21 C.F.R. § 111.35"
title: "21"
number: "111.35"
heading: "Under this subpart D, what records must you make and keep?"
url: "https://uscodex.org/cfr/21/111.35"
---

# §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;
  - (5) Backup file(s) of current software programs (and of outdated software that is necessary to retrieve records that you are required to keep in accordance with [subpart P](/cfr/21/subpartP.md) of this part, when current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.

## Notes

### Authority

Authority: 21 U.S.C. 321, 342, 343, 371, 374, 381, 393; 42 U.S.C. 264.

### Source

Source: 72 FR 34942, June 25, 2007, unless otherwise noted.