CFR section
21 CFR 111.210(f): What must the master manufacturing record include?
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 111.210(f) |
|---|---|
| Section | What must the master manufacturing record include? |
| 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) | (f) A statement of theoretical yield of a manufactured dietary supplement expected at each point, step, or stage of the manufacturing process where control is needed to ensure the quality of the dietary supplement, and the expected yield when you finish manufacturing the dietary supplement, including the maximum and minimum percentages of theoretical yield beyond which a deviation investigation of a batch is necessary and material review is conducted and disposition decision is made; |
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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.