CFR section
21 CFR 111.75(b): What must you do to determine whether specifications are met?
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 111.75(b) |
|---|---|
| Section | What must you do to determine whether specifications are met? |
| 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 | Food/Cosmetics |
| Regulation text (excerpt) | (b) You must monitor the in-process points, steps, or stages where control is necessary to ensure the quality of the finished batch of dietary supplement to: (1) Determine whether the in-process specifications are met; and (2) Detect any deviation or unanticipated occurrence that may result in a failure to meet specifications. |
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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.