CFR section
21 CFR 111.103: What are the requirements under this subpart F for written procedures?
PART 111-CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS · Subpart F-Production and Process Control System: Requirements for Quality Control
Key facts
| Citation | 21 CFR 111.103 |
|---|---|
| Section | What are the requirements under this subpart F for written procedures? |
| Part | PART 111-CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS |
| Subpart | Subpart F-Production and Process Control System: Requirements for Quality Control |
| Subchapter | 21 CFR B Food |
| Product types cited | Devices, Drugs, Food/Cosmetics, General, Veterinary |
| Regulation text (excerpt) | You must establish and follow written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making a disposition decision, and for approving or rejecting any reprocessing. |
At a glance
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About CFR sections cited by the FDA
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.