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 -組分，包裝和標(biāo)簽
?您必須對(duì)組分容器進(jìn)行目測(cè)以確保它們適合使用，并檢查這些貨物的相關(guān)文件，以確保這些物料與您的訂單一致。 （111.155）
?您必須對(duì)標(biāo)簽和包裝的容器進(jìn)行目測(cè)以確保它們適合使用，并檢查這些貨物的相關(guān)文件，以確保這些物料與您的訂單一致。 （111.160）
?您必須對(duì)進(jìn)廠物料進(jìn)行檢查，隔離，采集有代表性的樣本，執(zhí)行質(zhì)量控制審查批準(zhǔn)，并使用標(biāo)識(shí)符或代碼，使每批物料都能追溯到供應(yīng)商。 （111.155和111.160）
?你必須在一個(gè)丟棄物料隔離系統(tǒng)下清楚地鑒別、持有和控制任何因不適用而被拒的組分、包裝和標(biāo)簽。 （111.170）
?您必須有書面程序并保留記錄，以對(duì)符合本款規(guī)定進(jìn)行存檔。 （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 – 主生產(chǎn)記錄
?您必須為生產(chǎn)的每個(gè)獨(dú)特配方的膳食補(bǔ)充劑以及每個(gè)批量都編寫書面的主生產(chǎn)記錄（MMR）。
?您必須在主生產(chǎn)記錄中指明控制和程序，以確保每一批膳食補(bǔ)充劑都符合既定規(guī)格。 （111.205）
?每個(gè)母版生產(chǎn)記錄必須辨識(shí)生產(chǎn)過程中每個(gè)需要受控的點(diǎn)、步驟和階段的標(biāo)準(zhǔn)，以確保膳食補(bǔ)充劑的質(zhì)量，并且膳食補(bǔ)充劑的包裝與貼標(biāo)操作與主生產(chǎn)記錄上的要求一致。 （111.210）
?主生產(chǎn)記錄必須包括所生產(chǎn)補(bǔ)充劑的完整特性，所用組分的完整清單，這些組分的重量或體積，理論與預(yù)期收率，包裝描述和代表性標(biāo)簽，以及其他本款要求的書面指示。（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 - 批生產(chǎn)記錄
?您每生產(chǎn)一批膳食補(bǔ)充劑，必須準(zhǔn)備相應(yīng)的批生產(chǎn)記錄。 （111.255）
?批生產(chǎn)記錄必須包括批次或批號(hào)，列明使用的設(shè)備和生產(chǎn)線，對(duì)設(shè)備和加工線進(jìn)行維護(hù)、清潔和消毒的日期和時(shí)間，或交叉引用這些信息，所有用掉組分的鑒別和重量，實(shí)際收率的聲明，所有測(cè)試的結(jié)果，列明執(zhí)行所有生產(chǎn)、包裝和貼標(biāo)操作的人員和日期，批次丟棄處理，以及與該批產(chǎn)品有關(guān)的任何其他信息和行動(dòng)。 （111.260）

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