美國良好操作規(guī)范

1、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 21-FOOD AND DRUGS 標(biāo)題 21 -食品和藥物 CHAPTER I-FOOD 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 B-FOOD FOR HUMAN CONSUMPTION 子章節(jié) B 組 -人

2、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充劑控股作業(yè) Subpart A-General Provisions 子部分 - 一般規(guī)定 Sec. 秒。 111.1 Who is subject to this part? 111.1 誰是受這 部分？ (a) Except as provided by

3、paragraph (b) of this section, you are subject to this part if you manufacture, package, label, or hold a dietary supplement, including: (一)除提供段(二 本節(jié))，你必須遵守 ， 如果你這部分的制造，包裝，標(biāo) 簽，或持有飲食的補充，其中包括： (1) A dietary supplement you manufacture but that is packaged or labeled by another person; and ( 1)膳食補充 劑 ，

4、但你制造的包裝物或由他人標(biāo)記 ;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 補充劑進口或在任何國家或美國境內(nèi)的進口提供， 哥倫比 亞特區(qū)，或波多黎各聯(lián)邦。 (b) The requirements pertaining to holding dietary supplements do not

5、 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)膳食補充劑并不適用于你是否保持在一 個直接零售個人消費者零售的唯一目的建立的膳食補充 劑。 A retail establishment does not include a warehouse or other storage facility for a retail

6、er or a warehouse or other storage facility that sells directly to individual consumers. 阿零售的建立 ， 并不包括為零售商或倉庫或其他存儲設(shè) 施 ， 銷售直接向個人消費者倉庫或其他存儲設(shè)施。 Sec. 秒。 111.3 What definitions apply to this part? 111.3 什么定義適用于本部分？ The definitions and interpretations of terms in section 201 of the Federal Food, Drug, and

7、 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 ， 使用的條款就本部分。 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

8、 or packaging of a particular dietary supplement. 實際收益率是指實際上是在 任何制造或包裝特殊膳食補充劑生產(chǎn)數(shù)量適當(dāng)?shù)牟襟E。 Batch means a specific quantity of a dietary supplement that is uniform, that is intended to meet specifications for identity, purity, strength, and composition, and that is produced during a specified time perio

9、d according to a single manufacturing record during the same cycle of manufacture. 批次指飲食補 充劑是一致的，便是為了滿足身份，純度，強度規(guī)格，和 組成， 具體數(shù)量 ， 即在規(guī)定的時限內(nèi)根據(jù)一個單一的生 產(chǎn)過程中產(chǎn)生的記錄的生產(chǎn)同一周期。 Batch number, lot number, or control number means any distinctive group of letters, numbers, or symbols, or any combination of them, from

10、which the complete history of the manufacturing, packaging, labeling, and/or holding of a batch or lot of dietary supplements can be determined. 批 號，批號，或控制數(shù)是指任何字母，數(shù)字或符號，或任何 組合，獨特的一群 ， 從其中的制造，包裝標(biāo)簽，完整的 歷史，和 / 或批處理或很多持有膳食補充劑可確定。 Component means any substance intended for use in the manufacture of a die

11、tary 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 ， 包括那些可能不會出現(xiàn)在膳食補充劑 完成一批物質(zhì)在膳食補充劑的生產(chǎn)用途。 組成部分包括膳 食成分(如第 201(后)的行為)和其他說明材料。 Contact sur

12、face means any surface that contacts a component or dietary supplement, and those surfaces from which drainage onto the component or dietary supplement, or onto surfaces that contact the component or dietary supplement, occurs during the normal course of operations. 接觸面指任 何表面接觸組件或營養(yǎng)補充劑， 以及那些從表面上的排水

13、組件或營養(yǎng)補充劑， 或接觸到的表面 ， 組件或營養(yǎng)補充 劑，在正常操作期間發(fā)生。 Examples of contact surfaces include containers, utensils, tables, contact surfaces of equipment, and packaging. 表面接觸的例子包括容器，用 具，表，接觸的設(shè)備表面和包裝。 Ingredient means any substance that is used in the manufacture of a dietary supplement and that is intended to be pr

14、esent 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 在一個膳食補充劑生產(chǎn)中使用的物質(zhì) ， 并擬在膳食補充 劑完成一批存在。 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) 。 In-process material means any material t

15、hat is fabricated, compounded, blended, ground, extracted, sifted, sterilized, derived by chemical reaction, or processed in any other way for use in the manufacture of a dietary supplement. 在進程 的任何物質(zhì)手段是捏造的，復(fù)雜，混合，地面，提取，篩 選，消毒， 通過化學(xué)反應(yīng)， 或以任何其他方式處理在膳食 補充劑的生產(chǎn)使用得來的材料。 Lot means a batch, or a specific ide

16、ntified portion of a batch, that is uniform and that is intended to meet specifications for identity, purity, strength, and composition; 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 t

17、hat is uniform and that is intended to meet specifications for identity, purity, strength, and composition. 地段指一批，或特定確定了一個批處理 部分，即是一致的 ， 就是為了滿足身份，純度，強度規(guī) 格，并組成 ; 或者，在連續(xù)過程中產(chǎn)生的飲食的補充，具 體案件確定數(shù)額的方式生產(chǎn)在時間和數(shù)量的指定單位 ， 是一致的 ， 目的是要滿足的身份，純度，強度規(guī)格，和 組成。 Microorganisms means yeasts, molds, bacteria, viruses, and oth

18、er similar microscopic organisms having public health or sanitary concern. 微生物是指酵母菌，霉菌，細菌，病毒 和其他類似的具有公共健康或衛(wèi)生關(guān)注的微生物。 This definition includes species that: 這個定義包括物種： (1) May have public health significance; (1)5 月對公眾衛(wèi) 生的重要性 ; (2) May cause a component or dietary supplement to decompose; ( 2)可能會導(dǎo)致部分或膳

19、食補充劑分解; (3) Indicate that the component or dietary supplement is contaminated with filth; or ( 3)表明 ， 組件或膳食補充 劑與污物污染 ;或 (4) Otherwise may cause the component or dietary supplement to be adulterated. ( 4)，否則可能會導(dǎo)致部分 或營養(yǎng)補充劑是摻假。 Must is used to state a requirement. 必須用于國家規(guī)定。 Pest means any objectionable

20、 insect or other animal including birds, rodents, flies, mites, and larvae. 害蟲是指 任何不良昆蟲或其他動物包括鳥類， 老鼠， 蒼蠅， 螨蟲和 幼蟲。 Physical plant means all or any part of a building or facility 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

21、裝， 標(biāo)簽， 或舉辦膳食補 充劑連接使用設(shè)施的一部分。 Product complaint means any communication 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 complaints

22、 are: Foul odor, off taste, illness or injury, disintegration time, color variation, tablet size or size variation, under-filled container, foreign material in a dietary supplement container, improper packaging, mislabeling, or dietary supplements that are superpotent, subpotent, or contain the wron

23、g 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 膳食補充劑的質(zhì)量， 這可能與目前的良好生產(chǎn)規(guī)范。 產(chǎn)品 投訴的例子有：難聞的氣味，關(guān)閉口味，生病或受傷，解 體時，顏色的變化， 平板尺寸或大小的變化， 在充滿容器， 異 物在 膳食 補充 劑容 器， 包裝 不當(dāng) ，起 假， 或者 是 superpotent, subpotent,或控制飲食補充劑錯誤的成

24、分， 或含有藥物或其他污染物(如細菌，農(nóng)藥，霉菌毒素，玻 璃,鉛)。 Quality means that the dietary supplement consistently meets the established specifications for identity, purity, strength, and composition, and limits on contaminants, and has been manufactured, packaged, labeled, and held under conditions to prevent adulteration

25、under section 402(a)(1), (a)(2), (a)(3), and (a)(4) of the act. 質(zhì)量是指膳食補充劑始終符合身份， 純度，強度既定的規(guī)范，和組成，以及污染物的限制，并 已生產(chǎn)，包裝，標(biāo)簽和條件下進行 ， 以防止根據(jù)第 402 (1) (1 摻假)，(1) (2), (1) (3),和(a) (4)行為。 Quality control means a planned and systematic operation or procedure for ensuring the quality of a dietary supplement. 質(zhì)量控制

26、手段 , 有計劃和有系統(tǒng)的運作 , 確保膳食補 充劑的質(zhì)量或程序。 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,誰您指定組,對您的質(zhì)量控制操作負責(zé)。 Representative sample means a sample that

27、consists of an adequate number of units that are drawn based on rational criteria, such as random sampling, and that are intended to ensure that the sample accurately portrays the material being sampled. 代表性的樣本是指樣本的足夠數(shù)量的單位所組 成的基礎(chǔ)上制定合理的標(biāo)準(zhǔn) , 如隨機抽樣, 并說是為了 確保樣本準(zhǔn)確地描繪了被采樣的材料。 Reprocessing means using, in

28、the manufacture of a dietary supplement, clean, uncontaminated components or dietary supplements that have been previously removed from manufacturing and that have been made suitable for use in the manufacture of a dietary supplement. 使用后處理方法 的膳食補充劑生產(chǎn), 清潔無污染組件或膳食補充劑, 先前 已刪除從制造業(yè)和已作出在膳食補充劑的生產(chǎn)使用。 Reser

29、ve sample means a representative sample of product that is held for a designated period of time. 儲備樣本指產(chǎn) 品 , 在一段時間指定期間舉行的代表性。 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

30、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)處理的一個過程 , 是在破壞公 共健康的微生物的生長細胞 , 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)品或其對消費者的安全。 Theoretical

31、yield means the quantity that would be produced at any appropriate step of manufacture or packaging of a particular dietary supplement, based upon the quantity of components or packaging to be used, in the absence of any loss or error in actual production. 理論產(chǎn)量是指在沒有任 何損失或錯誤的情況下實際生產(chǎn)數(shù)量將在任何制造或包 裝特殊膳食補充

32、劑的適當(dāng)步驟后組件或包裝數(shù)量為基礎(chǔ), 制作使用。 Water activity (aw) is a measure of the free moisture in a component or dietary supplement and is the quotient of the water vapor pressure of the substance divided by the vapor pressure of pure water at the same temperature. 水分活度 ( Aw )為是一個組件或膳食補充劑自由水分的措施 , 是 由單純的水在相同溫度下的蒸氣壓

33、力分為物質(zhì)的水蒸汽 壓力商。 We means the US Food and Drug Administration (FDA). 我 們指美國食品及藥物管理局 (FDA)。 You means a person who manufactures, packages, labels, or holds dietary supplements. 你是指一個人誰制造,包裝, 標(biāo)簽,或持有膳食補充劑。 Sec. 秒 。111.5 Do other statutory provisions and regulations apply? 111.5 做其他法定規(guī)定和條例適用？ In addition

34、to this part, you must comply with other applicable statutory provisions and regulations under the act related to dietary supplements. 除了這部分, 你必須遵守其 他適用的法律規(guī)定和有關(guān)膳食補充劑的行為規(guī)則。 Subpart B-Personnel 部分 B -人事 Sec. 秒。 111.8 What are the requirements under this subpart B for written procedures? 111.8 什么是根據(jù)本書面

35、程序 , 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。 Sec. 秒。 111.10 What requirements apply for preventing microbial contamination from sick or infected personnel and for hygienic practices? 111.10 什么要求防止生病或受感染 人員的微生物污

36、染和衛(wèi)生習(xí)慣申請？ (a) Preventing microbial contamination . ( 1) 防止微生物 污染 。 You must take measures to exclude from any operations any person who might be a source of microbial contamination, due to a health condition, where such contamination may occur, of any material, including components, dietary suppleme

37、nts, and contact surfaces used in the manufacture, packaging, labeling, or holding of a dietary supplement. 你必須采取措施 ， 排除任何行動 ， 任何人可能是誰微生物污染的來源， 由于衛(wèi)生條件下， 這 種污染可能發(fā)生的任何材料， 包括組件， 膳食補充劑， 并 在接觸面用于制造包裝， 標(biāo)簽，或膳食補充劑舉行。 Such measures include the following: 這些措施包括以下內(nèi)容： (1) Excluding from working in any operatio

38、ns that may result in contamination any person who, by medical examination, the persons acknowledgement, or supervisory observation, is shown to have, or appears to have, an illness, infection, open lesion, or any other abnormal source of microbial contamination, that could result in microbial conta

39、mination of components, dietary supplements, or contact surfaces, until the health condition no longer exists; and ( 1)由任何 行動的工作 ， 可能導(dǎo)致在任何誰污染， 醫(yī)生檢查， 該人 的確認， 或監(jiān)督觀察， 結(jié)果表明有， 或看來， 疾病， 感染， 開放病變，或任何人排除其他不正常的微生物污染的來 源， 這可能對部分微生物污染的結(jié)果， 膳食補充劑， 或接 觸面，直到健康狀況不再存在 ;及 (2) Instructing your employees to notify thei

40、r supervisor(s) if they have or if there is a reasonable possibility that they have a health condition described in paragraph (a)(1) of this section that could result in microbial contamination of any components, dietary supplements, or any contact surface. ( 2)指導(dǎo)你的員工通知其主管 (擰)，如果他們有或有合 理的可能性 ， 他們有一個

41、健康狀況 ， 在本節(jié)段可能導(dǎo) 致微生物污染的任何組成部分( 1)( 1)所描述，膳食補 充劑，或任何接觸面。 (b) Hygienic practices . If you work in an operation during which adulteration of the component, dietary supplement, or contact surface could occur, you must use hygienic practices to the extent necessary to protect against such contamination of

42、 components, dietary supplements, or contact surfaces. (二) 衛(wèi)生習(xí)慣 。如果你在行動期間 ， 該組件摻假， 做法在必要情況下 ， 以防止這種污染成分， 膳食補充劑， 或聯(lián)系表 面。 These hygienic practices include the following: 這些衛(wèi)生習(xí)慣包括以下內(nèi)容： (1) Wearing outer garments in a manner that protects against the contamination of components, dietary supplements, or

43、any contact surface; ( 1)穿著的方式 ， 對部分污染的保 護外衣，膳食補充劑，或任何接觸面 ; (2) Maintaining adequate personal cleanliness; ( 2)保持適 當(dāng)?shù)膫€人清潔 ; (3) Washing hands thoroughly (and sanitizing if necessary to protect against contamination with microorganisms) in an adequate hand-washing facility: ( 3)徹底洗手(如有必要 的消毒 ， 以防止微生物

44、污染與適當(dāng)?shù)氖?洗手設(shè)施： (i) Before starting work; and ( i )在開始工作 ; (ii) At any time when the hands may have become soiled or contaminated; (二在任何時候手中可能已經(jīng)成為時間) 弄臟或污染 ; (4) Removing all unsecured jewelry and other objects that might fall into components, dietary supplements, equipment, or packaging, and removing

45、 hand jewelry that cannot be adequately sanitized during periods in which components or dietary supplements are manipulated by hand. ( 4)刪除所 有無擔(dān)保珠寶和其他物品可能落入組件， 膳食補充劑， 設(shè) 備或包裝， 并消除手工首飾 ， 不能在其中得到充分的組 件或膳食補充劑是由手工操作時期消毒。If hand jewelry cannot be removed, it must be covered by material that is maintained

46、in an intact, clean, and sanitary condition and that effectively protects against contamination of components, dietary supplements, or contact surfaces; 如果手首飾不能 被刪除， 它必須涵蓋材料 ， 保持一個完整的， 清潔和衛(wèi) 生情況 ， 并有效地保護了對組件的污染，膳食補充劑， 或接觸面 ; (5) Maintaining gloves used in handling components or dietary supplements in

47、 an intact, clean, and sanitary condition. ( 5)保持手套用在處理一個完整的， 清潔和衛(wèi) 生情況組件或膳食補充劑。 The gloves must be of an impermeable material; 該手套必須是一個防滲材料 ; 膳食補充劑， 或接觸面可能發(fā)生的工作， 您必須使用衛(wèi)生 (c) Each person engaged in manufacturing, packaging, labeling, or holding, or in performing any quality control operations, must h

48、ave the education, training, or experience to perform the persons assigned functions. (三)每個人從 事制造， 包裝，標(biāo)簽，或控股， 或進行任何質(zhì)量控制操作， 必須有教育， 培訓(xùn)或經(jīng)驗的人來執(zhí)行的分配職能。 Sec. 秒 。 111.13 What supervisor requirements apply? 111.13上級的規(guī)定適用于什么？ (a) You must assign qualified personnel to supervise the manufacturing, packaging,

49、labeling, or holding of dietary supplements. ( 1)您必須指定合格的人員來監(jiān)督制造， 包裝，標(biāo)簽，或膳食補充劑舉行。 (b) Each supervisor whom you use must be qualified by education, training, or experience to supervise. (二)每個 主管人必須為您使用合格的教育，培訓(xùn)，監(jiān)督或經(jīng)驗。 Sec. 秒。 111.14 Under this subpart B, what records must you make and keep? 在這個子部分 B 1

50、11.14 ，什么記錄必 須保持你的？ (6) Wearing, where appropriate, in an effective manner, hair nets, caps, beard covers, or other effective hair restraints; (6)服裝，在適當(dāng)情況下，有效地，頭發(fā)網(wǎng)，帽子，胡 須套，或其他有效頭發(fā)限制 ; (7) Not storing clothing or other personal belongings in areas where components, dietary supplements, or any contact

51、 surfaces are exposed or where contact surfaces are washed; (七) 不儲存在那里組成部分， 膳食補充劑， 或任何接觸 面接觸或接觸面的清洗領(lǐng)域的衣物或其他個人財物 ; (8) Not eating food, chewing gum, drinking beverages, or using tobacco products in areas where components, dietary supplements, or any contact surfaces are exposed, or where contact surf

52、aces are washed; and 地區(qū)( 8)不進食， 嚼口香 糖，喝飲料，或在使用煙草制品成分，膳食補充劑，或任 何接觸面接觸，或接觸面的清洗 ;及 (9) Taking any other precautions necessary to protect against the contamination of components, dietary supplements, or contact surfaces with microorganisms, filth, or any other extraneous materials, including perspiratio

53、n, hair, cosmetics, tobacco, chemicals, and medicines applied to the skin. ( 9) 采取任何必要對零部件的污染， 保護， 膳食補充劑， 或與 其他預(yù)防措施表面微生物， 污物，或任何其他無關(guān)的材料， 包括出汗，頭發(fā)，化妝品，煙草，化學(xué)品，并應(yīng)用于皮膚 藥品。 Sec. 秒。 111.12 What personnel qualification requirements apply? 111.12什么資格要求的人員申請？ (a) You must have qualified employees who manufact

54、ure, package, label, or hold dietary supplements. ( 1)您必須擁 有合格的員工誰制造，包裝，標(biāo)簽，或持有膳食補充劑。 (b) You must identify who is responsible for your quality control operations.(b)你必須確定誰是你的質(zhì)量控制操 作負責(zé)。 Each person who is identified to perform quality control operations must be qualified to do so and have distinct an

55、d separate responsibilities related to performing such operations from those responsibilities that the person otherwise has when not performing such operations. 每個確 定誰是執(zhí)行質(zhì)量控制操作者必須具備這樣做 ， 并且有獨 特和不同的有關(guān)履行這些職責(zé)的人 ， 否則也當(dāng)不執(zhí)行這 些行動的這種行動的責(zé)任。 (a) You must make and keep records required under this subpart B in

56、accordance with subpart P of this part. ( 1)您 必須制作并保存在此按照本部分附 P 附乙所需的記錄。 (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; and ( 1)書面程序履行本附 B 的要求 ; (2) Documentation of training, including the date of the t

57、raining, the type of training, and the person(s) trained. (2) 文檔的培訓(xùn)，包括培訓(xùn)日期，培訓(xùn)類型，而該人(擰)培 Subpart C-Physical Plant and Grounds C 小節(jié) -物理設(shè)備和 場地 Sec. 秒。 111.15 What sanitation requirements apply to your physical plant and grounds? 111.15 什么衛(wèi)生要求適用于您 的身體工廠和理由？ (5) If your plant grounds are bordered by grou

58、nds 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 contaminatio

59、n. ( 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 ， 可能是一個污染源。 (a) Grounds . (一) 理由 。 You must keep the grounds of your physical plant in a condition that protects against the contamination of components, dietary supplements, or contact surfaces. 你

60、必須保持一個條件 ， 對組件的污染 保護，膳食補充劑， 或聯(lián)絡(luò)您的身體植物表面的理由。 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,