褰撳墠浣嶇疆: 棣栭〉? 鏀跨瓥娉曡? 鍥藉娉曡? 搂106.25 濠村効閰嶆柟绮夌殑鐢熶骇鎺у埗(In-process control)

搂106.25 濠村効閰嶆柟绮夌殑鐢熶骇鎺у埗(In-process control)

鎵弿浜岀淮鐮 鍒嗕韩濂藉弸鍜屾湅鍙嬪湀
鏀惧ぇ瀛椾綋缂╁皬瀛椾綋2011-08-20 21:24:54 鏉ユ簮锛欸PO 娴忚娆℃暟锛欬span id="hits">3135
鏍稿績鎻愮ず锛氬姣忎竴绉嶅┐鍎块厤鏂圭矇锛屽繀椤荤紪鍒朵竴濂楁寚瀵兼€х殑鐢熶骇绋嬪簭骞剁敱璇ョ敓浜у晢鐨勪富绠″鎵广€傚鏋滀笉鎸夌収搂106.30锛坆锛夛紙1锛夌殑瑙勫畾瀵规瘡涓€鎵规垚鍝佽繘琛屽垎鏋愶紝鍒堕€犲晢蹇呴』瀵瑰姞宸ヨ繃绋嬩腑鐨勬瘡涓€鎵归厤鏂欒繘琛屽悇椤瑰垎鏋愶紝濡傚浐褰㈢墿銆佽泲鐧借川銆佽剛鑲拰纰虫按鍖栧悎鐗┿€佹瘡绉嶈惀鍏荤礌棰勬贩鏂欎腑鐨勬寚绀鸿惀鍏荤礌浠ュ強闄ゆ涔嬪鐨勫悇绉嶅崟鐙坊鍔犵殑钀ュ吇绱狅紝鎸夋湰鑺傦紙b锛夛紙1锛墌锛?锛変腑鍙欒堪鐨勫垎鏋愭柟娉曞埗鎴愭渶缁堢█閲婃恫鍚庢祴瀹氬浐褰㈢墿鎴栬惀鍏荤礌浠ョ‘瀹氬悎閫傜殑绋€閲婂害銆侟/div>
鍙戝竷鍗曚綅
FDA
FDA
鍙戝竷鏂囧彿 鏆傛棤
鍙戝竷鏃ユ湡 鏆傛棤 鐢熸晥鏃ユ湡 鏆傛棤
鏈夋晥鎬х姸鎬?/th> 搴熸鏃ユ湡 鏆傛棤
澶囨敞 瀵规瘡涓€绉嶅┐鍎块厤鏂圭矇锛屽繀椤荤紪鍒朵竴濂楁寚瀵兼€х殑鐢熶骇绋嬪簭骞剁敱璇ョ敓浜у晢鐨勪富绠″鎵广€傚鏋滀笉鎸夌収搂106.30锛坆锛夛紙1锛夌殑瑙勫畾瀵规瘡涓€鎵规垚鍝佽繘琛屽垎鏋愶紝鍒堕€犲晢蹇呴』瀵瑰姞宸ヨ繃绋嬩腑鐨勬瘡涓€鎵归厤鏂欒繘琛屽悇椤瑰垎鏋愶紝濡傚浐褰㈢墿銆佽泲鐧借川銆佽剛鑲拰纰虫按鍖栧悎鐗┿€佹瘡绉嶈惀鍏荤礌棰勬贩鏂欎腑鐨勬寚绀鸿惀鍏荤礌浠ュ強闄ゆ涔嬪鐨勫悇绉嶅崟鐙坊鍔犵殑钀ュ吇绱狅紝鎸夋湰鑺傦紙b锛夛紙1锛墌锛?锛変腑鍙欒堪鐨勫垎鏋愭柟娉曞埗鎴愭渶缁堢█閲婃恫鍚庢祴瀹氬浐褰㈢墿鎴栬惀鍏荤礌浠ョ‘瀹氬悎閫傜殑绋€閲婂害銆侟/td>

鏇村鍏充簬濠村効閰嶆柟绮夎川閲忔帶鍒剁▼搴忕殑娉曡锛岃璇﹁缇庡浗FDA 21 CFR 绗?06閮ㄥ垎鍏充簬濠村効閰嶆柟绮夎川閲忔帶鍒剁▼搴忕殑娉曡姹囨€狐/font>銆侟br />
銆€銆€§ 106.25 In-process control.

銆€銆€锛坅锛 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.

銆€銆€锛坆锛 Unless each batch of finished product is analyzed as specified in §106.30锛坆锛夛紙1锛? the manufacturer shall analyze each in-process batch for:

銆€銆€锛?锛 Solids;

銆€銆€锛?锛 Protein, fat, and carbohydrates 锛坈arbohydrates either by analysis or by mathematical difference锛堺

銆€銆€锛?锛 The indicator nutrient锛坰锛 in each nutrient premix;

銆€銆€锛?锛 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

銆€銆€锛?锛 Solids or an appropriate nutrient to confirm proper dilution when final dilution is made after performance of the analyses in paragraph 锛坆锛 锛?锛 through 锛?锛 of this section.

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