CFR section
21 CFR 111.35(b)(3): Under this subpart D, what records must you make and keep?
PART 111-CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS · Subpart D-Equipment and Utensils
Key facts
| Citation | 21 CFR 111.35(b)(3) |
|---|---|
| Section | Under this subpart D, what records must you make and keep? |
| Part | PART 111-CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS |
| Subpart | Subpart D-Equipment and Utensils |
| Subchapter | 21 CFR B Food |
| Product types cited | Drugs, Food/Cosmetics |
| Regulation text (excerpt) | (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… |
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Title 21 of the Code of Federal Regulations contains the FDA's regulations, including current good manufacturing practice and quality system requirements that inspections cite.