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§106.25 婴儿配方粉的生产控制(In-process control)
2011-08-20 21:24  点击:2816
发布单位:FDA
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发布日期:暂无
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废止日期:暂无
备注:对每一种婴儿配方粉,必须编制一套指导性的生产程序并由该生产商的主管审批。如果不按照§106.30(b)(1)的规定对每一批成品进行分析,制造商必须对加工过程中的每一批配料进行各项分析,如固形物、蛋白质、脂肪和碳水化合物、每种营养素预混料中的指示营养素以及除此之外的各种单独添加的营养素,按本节(b)(1)~(4)中叙述的分析方法制成最终稀释液后测定固形物或营养素以确定合适的稀释度。

      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.
 

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