CFR section
21 CFR 111.80(b): What representative samples must you collect?
PART 111-CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS · Subpart E-Requirement to Establish a Production and Process Control System
Key facts
| Citation | 21 CFR 111.80(b) |
|---|---|
| Section | What representative samples must you collect? |
| Part | PART 111-CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS |
| Subpart | Subpart E-Requirement to Establish a Production and Process Control System |
| Subchapter | 21 CFR B Food |
| Product types cited | Drugs, Food/Cosmetics |
| Regulation text (excerpt) | (b) Representative samples of in-process materials for each manufactured batch at points, steps, or stages, in the manufacturing process as specified in the master manufacturing record where control is necessary to ensure the identity, purity, strength, and composition of dietary supplements to determine whether the in-process materials meet specifications established in accordance with § 111.70(c), and as applicable, § 111.70(a); |
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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.