【正文】 lity used for or in connection with manufacturing, packaging, labeling, or holding a dietary supplement. 物理植物是指所有或任何建筑物或或與制造，包裝，標(biāo)簽，或舉辦膳食補(bǔ)充劑連接使用設(shè)施的一部分。 or （3）表明 ， 組件或膳食補(bǔ)充劑與污物污染。 （1）5月對(duì)公眾衛(wèi)生的重要性。 or, in the case of a dietary supplement produced by continuous process, a specific identified amount produced in a specified unit of time or quantity in a manner that is uniform and that is intended to meet specifications for identity, purity, strength, and position. 地段指一批，或特定確定了一個(gè)批處理部分，即是一致的 ， 就是為了滿足身份，純度，強(qiáng)度規(guī)格，并組成。 Ingredient means any substance that is used in the manufacture of a dietary supplement and that is intended to be present in the finished batch of the dietary supplement. An ingredient includes, but is not necessarily limited to, a dietary ingredient as defined in section 201(ff) of the act. 成分是指在一個(gè)膳食補(bǔ)充劑生產(chǎn)中使用的物質(zhì) ， 并擬在膳食補(bǔ)充劑完成一批存在。 Component means any substance intended for use in the manufacture of a dietary supplement, including those that may not appear in the finished batch of the dietary supplement. Component includes dietary ingredients (as described in section 201(ff) of the act) and other ingredients. 組件是指任何人 ， 包括那些可能不會(huì)出現(xiàn)在膳食補(bǔ)充劑完成一批物質(zhì)在膳食補(bǔ)充劑的生產(chǎn)用途。 What definitions apply to this part? ？ The definitions and interpretations of terms in section 201 of the Federal Food, Drug, and Cosmetic Act (the act) apply to such terms when used in this part. For the purpose of this part, the following definitions also apply: 的定義和節(jié)聯(lián)邦食品，藥品和化妝品法（該法）201條款的解釋適用于本部分時(shí) ， 使用的條款就本部分。及 (2) A dietary supplement imported or offered for import in any State or territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico. （2）膳食補(bǔ)充劑進(jìn)口或在任何國(guó)家或美國(guó)境內(nèi)的進(jìn)口提供，哥倫比亞特區(qū)，或波多黎各聯(lián)邦。[聯(lián)邦法規(guī)] [Title 21, Volume 2] [標(biāo)題21，第2卷] [Revised as of April 1, 2008] [日期為2008年4月1日] [CITE: 21CFR111] [引用：21CFR111] TITLE 21FOOD AND DRUGS 標(biāo)題21 食品和藥物 CHAPTER IFOOD AND DRUG ADMINISTRATION 第一章食品和藥物管理局 DEPARTMENT OF HEALTH AND HUMAN SERVICES 部衛(wèi)生與公眾服務(wù) SUBCHAPTER BFOOD FOR HUMAN CONSUMPTION 子章節(jié)B組人類(lèi)食用的食物 PART 111 第111 CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS 現(xiàn)行良好操作規(guī)范在制造，包裝，標(biāo)簽，或?qū)κ称费a(bǔ)充劑控股作業(yè) Subpart AGeneral Provisions 子部分一般規(guī)定 Sec. 秒。 (b) The requirements pertaining to holding dietary supplements do not apply to you if you are holding those dietary supplements at a retail establishment for the sole purpose of direct retail sale to individual consumers. （二）的要求舉行有關(guān)膳食補(bǔ)充劑并不適用于你是否保持在一個(gè)直接零售個(gè)人消費(fèi)者零售的唯一目的建立的膳食補(bǔ)充劑。為此，下列定義也適用于： Actual yield means the quantity that is actually produced at any appropriate step of manufacture or packaging of a particular dietary supplement. 實(shí)際收益率是指實(shí)際上是在任何制造或包裝特殊膳食補(bǔ)充劑生產(chǎn)數(shù)量適當(dāng)?shù)牟襟E。組成部分包括膳食成分（如第201（后）的行為）和其他說(shuō)明材料。一種成分，包括但不一定限于，作為第201定義的膳食成分（法郎的行為）?；蛘?，在連續(xù)過(guò)程中產(chǎn)生的飲食的補(bǔ)充，具體案件確定數(shù)額的方式生產(chǎn)在時(shí)間和數(shù)量的指定單位 ， 是一致的 ， 目的是要滿足的身份，純度，強(qiáng)度規(guī)格，和組成。 (2) May cause a ponent or dietary supplement to depose?；?(4) Otherwise may cause the ponent or dietary supplement to be adulterated. （4），否則可能會(huì)導(dǎo)致部分或營(yíng)養(yǎng)補(bǔ)充劑是摻假。 Product plaint means any munication that contains any allegation, written, electronic, or oral, expressing concern, for any reason, with the quality of a dietary supplement, that could be related to current good manufacturing practice. Examples of product plaints are: Foul odor, off taste, illness or injury, disintegration time, color variation, tablet size or size variation, underfilled container, foreign material in a dietary supplement container, improper packaging, mislabeling, or dietary supplements that are superpotent, subpotent, or contain the wrong ingredient, or contain a drug or other contaminant (eg, bacteria, pesticide, mycotoxin, glass, lead). 產(chǎn)品投訴的任何通信手段包含任何指控，書(shū)面，電子或口頭表示關(guān)注因任何原因，與一名膳食補(bǔ)充劑的質(zhì)量，這可能與目前的良好生產(chǎn)規(guī)范。 Quality control personnel means any person, persons, or group, within or outside of your organization, who you designate to be responsible for your quality control operations. 質(zhì)量控制人員 ， 是指任何人，人，或在境內(nèi)或境外的組織，誰(shuí)您指定組，對(duì)您的質(zhì)量控制操作負(fù)責(zé)。 Sanitize means to adequately treat cleaned equipment, containers, utensils, or any other cleaned contact surface by a process that is effective in destroying vegetative cells of microorganisms of public health significance, and in substantially reducing numbers of other microorganisms, but without adversely affecting the product or its safety for the consumer. 消毒方法適當(dāng)處理的一個(gè)過(guò)程 ， 是在破壞公共健康的微生物的生長(zhǎng)細(xì)胞 ， 有效的清洗設(shè)備，容器，用具，或任何其他清潔接觸面，并能顯著減少其他微生物的數(shù)字，但不影響該產(chǎn)品或其對(duì)消費(fèi)者的安全。 You means a person who manufactures, packages, labels, or holds dietary supplements. 你是指一個(gè)人誰(shuí)制造，包裝，標(biāo)簽，或持有膳食補(bǔ)充劑。 What are the requirements under this subpart B for written procedures? ， 部分B的要求？ You must establish and follow written procedures for fulfilling the requirements of this subpart. 你必須建立和遵循履行本附書(shū)面程序的規(guī)定。 Such measures include the following: 這些措施包括以下內(nèi)容： (1) Excluding from working in any operations that may result in contamination any person who, by medical examination, the person39。 (b) Hygienic practices . If you work in an operation during which adulteration of the ponent, dietary supplement, or contact surface could occur, you must use hygienic practices to the extent necessary to protect against such contamination of ponents, dietary supplements, or contact surfaces. （二） 衛(wèi)生習(xí)慣 。 (2) Maintaining adequate personal cleanliness。 (ii) At any time when the hands may have bee soiled or contaminated。 如果手首飾不能被刪除，它必須涵蓋材料 ， 保持一個(gè)完整的，清潔和衛(wèi)生情況 ， 并有效地保護(hù)了對(duì)組件的污染，膳食補(bǔ)充劑，或接觸面。 (6) Wearing, where appropriate, in an effective manner, hair nets, caps, beard covers, or other effective hair restraints。 (8) Not eating food, chewing gum, drinking beverages, or using tobacco products in areas where ponents, dietary supplements, or any contact surfaces are exposed, or where contact surfaces are washed。 What personnel qualification requirements apply? ？ (a) You must have qualified employees who manufacture, package, label, or hold dietary supplements. （1）您必須擁有合格的員工誰(shuí)制造，包裝，標(biāo)簽，或持有膳食補(bǔ)充劑。s assigned f