【分享】21CFR111简介：膳食补充剂（中英文）

Subpart G –Components, Packaging, and Labeling
• You must visually examine containers of components to ensure they are appropriate for use and examine the paperwork for those shipments to ensure those materials are consistent with your purchase order. (111.155)
• You must visually examine containers of labels and packaging to ensure they are appropriate for use and examine the paperwork for those shipments to ensure those materials are consistent with your purchase order. (111.160)
• You must examine, quarantine, collect representative samples, perform an QC review for approval, and use some form of identifier or code to allow the trace back of each unique lot to the supplier. (111.155 and 111.160)
• You must clearly identify, hold, and control under a quarantine system for disposition, any component, packaging, and labels which have been rejected and are not suitable for manufacturing, packaging, or labeling operations. (111.170)
• You must have written procedures and keep records documenting compliance with this subsection. (111.180)
子部分的G -组分，包装和标签
•您必须对组分容器进行目测以确保它们适合使用，并检查这些货物的相关文件，以确保这些物料与您的订单一致。 （111.155）
•您必须对标签和包装的容器进行目测以确保它们适合使用，并检查这些货物的相关文件，以确保这些物料与您的订单一致。 （111.160）
•您必须对进厂物料进行检查，隔离，采集有代表性的样本，执行质量控制审查批准，并使用标识符或代码，使每批物料都能追溯到供应商。 （111.155和111.160）
•你必须在一个丢弃物料隔离系统下清楚地鉴别、持有和控制任何因不适用而被拒的组分、包装和标签。 （111.170）
•您必须有书面程序并保留记录，以对符合本款规定进行存档。 （111.180）
Subpart H – Ma-ster Manufacturing Record
• You must have a written ma-ster manufacturing record (MMR) for each unique formulation of dietary supplement manufactured and for each batch size.
• You must identify the controls and procedures in the ma-ster manufacturing record to ensure that each batch of dietary supplement meets the established specifications. (111.205)
• Each ma-ster manufacturing record must identify the specifications for all points, steps, or stages in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the supplement is packaged and labeled as specified in the ma-ster manufacturing record. (111.210)
• The ma-ster manufacturing record must include the complete identity of the supplement to be manufactured, a complete list of the components used, the weights or measure of these components, the theoretical and expected yield, a description of the packaging and a representative label, and other written instructions required by this section. (111.210)
子部分的H – 主生产记录
•您必须为生产的每个独特配方的膳食补充剂以及每个批量都编写书面的主生产记录（MMR）。
•您必须在主生产记录中指明控制和程序，以确保每一批膳食补充剂都符合既定规格。 （111.205）
•每个母版生产记录必须辨识生产过程中每个需要受控的点、步骤和阶段的标准，以确保膳食补充剂的质量，并且膳食补充剂的包装与贴标操作与主生产记录上的要求一致。 （111.210）
•主生产记录必须包括所生产补充剂的完整特性，所用组分的完整清单，这些组分的重量或体积，理论与预期收率，包装描述和代表性标签，以及其他本款要求的书面指示。（111.210）
Subpart I – Batch Production Record
• You must prepare a batch production record every time you manufacture a batch of dietary supplement. (111.255)
• The batch production record must include the batch or lot number for the batch produced, the identity of the equipment and processing lines used, the date and time of the maintenance, cleaning, and sanitizing of the equipment and processing lines or a cross-reference to this information, the identity and weights of all components used, a statement of actual yield, the results of all testing performed, the dates and identification of persons performing all manufacturing, packaging, and labeling operations, the disposition of the batch, and any other information action which involved the batch. (111.260)
子部分I - 批生产记录
•您每生产一批膳食补充剂，必须准备相应的批生产记录。 （111.255）
•批生产记录必须包括批次或批号，列明使用的设备和生产线，对设备和加工线进行维护、清洁和消毒的日期和时间，或交叉引用这些信息，所有用掉组分的鉴别和重量，实际收率的声明，所有测试的结果，列明执行所有生产、包装和贴标操作的人员和日期，批次丢弃处理，以及与该批产品有关的任何其他信息和行动。 （111.260）

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