§106.25 婴儿配方粉的生产控制(In-process control)

      更多关于婴儿配方粉质量控制程序的法规，请详见 美国FDA 21 CFR 第106部分关于婴儿配方粉质量控制程序的法规汇总。

　　§ 106.25   In-process control.

　　（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.