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Code of Federal Regulations (Last Updated: May 6, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter B - Food for Human Consumption |
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Part 106 - Infant Formula Requirements Pertaining to Current Good Manufacturing Practice, Quality Control Procedures, Quality Factors, Records and Reports, and Notifications |
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Subpart B - Current Good Manufacturing Practice |
§ 106.25 - In-process control.
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(a) For each infant formula, a master manufacturing order shall be prepared and approved by a responsible official of the manufacturer. The manufacturer shall establish a quality control system that assures and verifies the addition of each ingredient specified in the manufacturing order.
(b) Unless each batch of finished product is analyzed as specified in §106.30(b)(1), the manufacturer shall analyze each in-process batch for:
(1) Solids;
(2) Protein, fat, and carbohydrates (carbohydrates either by analysis or by mathematical difference);
(3) The indicator nutrient(s) in each nutrient premix;
(4) Each nutrient added independently of nutrient premixes during formulation of the product, except for linoleic acid, vitamin D, vitamin K, choline, inositol, and biotin; and
(5) Solids or an appropriate nutrient to confirm proper dilution when final dilution is made after performance of the analyses in paragraph (b) (1) through (4) of this section.