【正文】 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。[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。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。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）。 (2) May cause a ponent or dietary supplement to depose。 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。 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。 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面程序的規(guī)定。 (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 。 (ii) At any time when the hands may have bee soiled or contaminated。 (6) Wearing, where appropriate, in an effective manner, hair nets, caps, beard covers, or other effective hair restraints。 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。 Sec. 秒。 The methods for adequate ground maintenance include: 提供足夠的地面維修的方法包括： (1) Properly storing equipment, removing litter and waste, and cutting weeds or grass within the immediate vicinity of the physical plant so that it does not attract pests, harbor pests, or provide pests a place for breeding。及 (5) If your plant grounds are bordered by grounds not under your control, and if those other grounds are not maintained in the manner described in this section, you must exercise care in the plant by inspection, extermination, or other means to exclude pests, dirt, and filth or any other extraneous materials that may be a source of contamination. （5如果您的工廠理由的理由不接壤 ， 在你的控制，如果這些其他原因不能在本節(jié)中描述的方式保存），你必須行使的檢查，消滅，或其他手段植物護(hù)理排除害蟲，灰塵和臟物或任何其他無關(guān)的材料 ， 可能是一個(gè)污染源。 （一）保持清潔和衛(wèi)生條件。 (d) Pest control . （四） 害蟲控制 。 (1) You must provide water that is safe and sanitary, at suitable temperatures, and under pressure as needed, for all uses where water does not bee a ponent of the dietary supplement. （1）你必須提供的水是安全和衛(wèi)生，在適當(dāng)溫度和壓力下 ， 根據(jù)需要，為所有使用在水不會(huì)成為膳食補(bǔ)充劑的成分。 （3）避免成為污染來源的組件，膳食補(bǔ)充劑，供水，或任何接觸面，或創(chuàng)建不衛(wèi)生的條件。浴室必須保持干凈 ， 不能有污染的可能來源的組件，膳食補(bǔ)充劑，或接觸的表面。 （2）最大限度地降低垃圾吸引，港口，或成為滋生蚊蟲的地方的潛力。 What are the requirements under this subpart C for written procedures? ， 根據(jù)本C小節(jié)要求？ You must establish and follow written procedures for cleaning the physical plant and for pest control. 你必須建立和遵循清潔物質(zhì)設(shè)備和控制蟲害的書面程序。 （1）接收，識(shí)別，持有，使用和截留，組件，膳食補(bǔ)充劑，包裝和標(biāo)簽將用于或在制造，包裝，標(biāo)簽，或膳食補(bǔ)充劑的舉行。 （5）清洗和消毒 ， 接觸面。 （二）照明燈，管道，水管 ， 不污染成分，膳食補(bǔ)充劑，或接觸面的滴水或其他滲漏，或冷凝物。 (e) Provide adequate light in: （五）提供適當(dāng)?shù)墓庠冢?(1) All areas where ponents or dietary supplements are examined, processed, or held。 (2) All areas where contact surfaces are cleaned。 （三）足夠的通風(fēng)或環(huán)境控制設(shè)備 ， 如氣流系統(tǒng)，包括過濾器，風(fēng)扇和其他空氣吹設(shè)備，盡量減少氣味（包括蒸汽和有毒氣體的地區(qū)），他們可能污染氣體成分，膳食補(bǔ)充劑，或接觸面。 and （6）包裝和標(biāo)簽的行動(dòng)。 （2）必要時(shí)分離，元件，膳食補(bǔ)充劑，包裝和標(biāo)簽 ， 將在制造中使用的組件，膳食補(bǔ)充劑，包裝或標(biāo)簽 ， 正在等待材料進(jìn)行審查和處理決定，再加工，或等待處理后排斥反應(yīng)。 What design and construction requirements apply to your physical plant? ？ Any physical plant you use in the manufacture, packaging, labeling, or holding of dietary supplements must: 您的任何物質(zhì)設(shè)備的制造，包裝，標(biāo)志，或膳食補(bǔ)充劑控股必須使用： (a) Be suitable in size, construction, and design to facilitate maintenance, cleaning, and sanitizing operations。 and （3）對(duì)部分污染保護(hù)，膳食補(bǔ)充劑，任何接觸面，水的供應(yīng)和自己的身體周圍的場(chǎng)地設(shè)備。 You must provide handwashing facilities that are designed to ensure that an employee39。 and （4）在所有領(lǐng)域提供足夠的地面排水層時(shí)受水浸式清潔或正常操作釋放或排放水或其他液體廢物的地板上。 (f) Plumbing . （六） 管道 。 （1）您絕不允許任何動(dòng)物或?qū)δ纳眢w廠房面積蟲害。 （二）對(duì)于在實(shí)驗(yàn)室的測(cè)試程序的使用。 (1) You must maintain your physical plant in a clean and sanitary condition。 (2) Maintaining roads, yards, and parking lots so that they do not constitute a source of contamination in areas where ponents, dietary supplements, or contact surfaces are exposed。 (b) You must make and keep the following records: （b）你必須制作并保存以下記錄： (1) Written procedures for fulfilling the requirements of this subpart B。 Each person who is identified to perform quality control operations must be qualified to do so and have