§106.25 嬰兒配方粉的生產(chǎn)控制(In-process control)

   2011-08-20 991
核心提示:更多關(guān)于嬰兒配方粉質(zhì)量控制程序的法規(guī),請(qǐng)?jiān)斠?jiàn)美國(guó)FDA 21 CFR 第106部分關(guān)于嬰兒配方粉質(zhì)量控制程序的法規(guī)匯總。   106.25 In

      更多關(guān)于嬰兒配方粉質(zhì)量控制程序的法規(guī),請(qǐng)?jiān)斠?jiàn) 美國(guó)FDA 21 CFR 第106部分關(guān)于嬰兒配方粉質(zhì)量控制程序的法規(guī)匯總

  § 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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