CFR section
21 CFR 111.325(b)(2): Under this subpart J, what records must you make and keep?
PART 111-CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS · Subpart J-Production and Process Control System: Requirements for Laboratory Operations
Key facts
| Citation | 21 CFR 111.325(b)(2) |
|---|---|
| Section | Under this subpart J, 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 J-Production and Process Control System: Requirements for Laboratory Operations |
| Subchapter | 21 CFR B Food |
| Product types cited | Drugs, Food/Cosmetics |
| Regulation text (excerpt) | (2) Documentation that laboratory methodology established in accordance with this subpart J is followed. (i) The person who conducts the testing and examination must document, at the time of performance, that laboratory methodology established in accordance with this subpart J is followed. (ii) The documentation for laboratory tests and examinations must include the results of the testing and examination. |
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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.