CFR section
21 CFR 111.205(b)(1): What is the requirement to establish a master manufacturing record?
PART 111-CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS · Subpart H-Production and Process Control System: Requirements for the Master Manufacturing Record
Key facts
| Citation | 21 CFR 111.205(b)(1) |
|---|---|
| Section | What is the requirement to establish a master manufacturing record? |
| Part | PART 111-CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS |
| Subpart | Subpart H-Production and Process Control System: Requirements for the Master Manufacturing Record |
| Subchapter | 21 CFR B Food |
| Product types cited | Drugs, Food/Cosmetics, General |
| Regulation text (excerpt) | (1) Identify specifications for the points, steps, or stages in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record; and |
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.