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美國(guó)良好操作規(guī)范-wenkub.com

2025-04-09 23:40 本頁(yè)面
   

【正文】 and (2)所有地區(qū) , 接觸面的清潔。 (2)當(dāng)風(fēng)扇和其他空中吹設(shè)備的使用,這些球迷和設(shè)備必須位于的方式 , 最大限度地降低對(duì)微生物的潛力和可吸入顆粒物的污染成分,膳食補(bǔ)充劑,或與經(jīng)營(yíng)的表面。 (iv) Equipment that controls temperature and humidity, when such equipment is necessary to ensure the quality of the dietary supplement。 (ii) Fixtures, ducts, and pipes that do not contaminate ponents, dietary supplements, or contact surfaces by dripping or other leakage, or condensate。 (7) Holding ponents or dietary supplements. (7)控股組件或膳食補(bǔ)充劑。 (5) Cleaning and sanitizing contact surfaces。 (3) Separating the manufacturing, packaging, labeling, and holding of different product types including different types of dietary supplements and other foods, cosmetics, and pharmaceutical products。 Your physical plant must have, and you must use, separate or defined areas of adequate size or other control systems, such as puterized inventory controls or automated systems of separation, to prevent contamination and mixups of ponents and dietary supplements during the following operations: 你的身體廠必須要有,你必須使用單獨(dú)的或定義 , 例如電腦化庫(kù)存管理或分離自動(dòng)化系統(tǒng)足夠的規(guī)?;蚱渌刂葡到y(tǒng),地區(qū),以防止在以下操作污染和零部件與膳食補(bǔ)充劑mixups: (1) Receiving, identifying, holding, and withholding from use, ponents, dietary supplements, packaging, and labels that will be used in or during the manufacturing, packaging, labeling, or holding of dietary supplements。 (一)在規(guī)模,適合建設(shè)和設(shè)計(jì) , 方便維修,清潔和消毒工作。 Sec. 秒。及 (4) Control hazardous waste to prevent contamination of ponents, dietary supplements, and contact surfaces. (4)控制危險(xiǎn)廢物 , 以防止污染成分,膳食補(bǔ)充劑,和接觸面。 (2) Minimize the potential for the trash to attract, harbor, or bee a breeding place for pests。s hands are not a source of contamination of ponents, dietary supplements, or any contact surface, by providing facilities that are adequate, convenient, and furnish running water at a suitable temperature. 您必須提供洗手的目的是確保雇員的手是不是對(duì)部分污染水源工程,膳食補(bǔ)充劑,或任何接觸面,通過提供足夠的設(shè)施,方便,運(yùn)行提供適當(dāng)溫度的水。 You must provide your employees with adequate, readily accessible bathrooms. The bathrooms must be kept clean and must not be a potential source of contamination to ponents, dietary supplements, or contact surfaces. 你必須提供足夠的,易于使用的浴室 , 你的員工。及 (5) Not allow backflow from, or cross connection between, piping systems that discharge waste water or sewage and piping systems that carry water used for manufacturing dietary supplements, for cleaning contact surfaces, or for use in bathrooms or handwashing facilities. (5)不允許倒流的,或交叉連接之間,管道系統(tǒng) , 排放廢水或污水管道清洗接觸面,或在浴室或使用手洗手設(shè)施系統(tǒng) , 進(jìn)行營(yíng)養(yǎng)補(bǔ)充品生產(chǎn)用水。 (3) Avoid being a source of contamination to ponents, dietary supplements, water supplies, or any contact surface, or creating an unsanitary condition。 The plumbing in your physical plant must be of an adequate size and design and be adequately installed and maintained to: 在您的物理設(shè)備水管必須是一個(gè)適當(dāng)?shù)囊?guī)模和設(shè)計(jì) , 并有足夠的安裝和維護(hù): (1) Carry sufficient amounts of water to required locations throughout the physical plant。 (e) Water supply . (五) 供水 。民警衛(wèi)隊(duì)或?qū)と谠试S對(duì)您的身體種植一些地區(qū)如果狗的存在將不會(huì)導(dǎo)致污染的部件,膳食補(bǔ)充劑,或聯(lián)系表面。 (3) You must identify and hold cleaning pounds, sanitizing agents, pesticides, pesticide chemicals, and other toxic materials in a manner that protects against contamination of ponents, dietary supplements, or contact surfaces. (3)您必須確定并保持清潔劑,消毒劑,殺蟲劑,農(nóng)藥化學(xué)品和方式 , 對(duì)污染保護(hù)的元件,膳食補(bǔ)充劑,或與其他有毒物質(zhì)的表面。 (iii) For maintaining or operating the physical plant or equipment。 (2) You must not use or hold toxic materials in a physical plant in which ponents, dietary supplements, or contact surfaces are manufactured or exposed, unless those materials are necessary as follows: (2)不得使用或持有物理工廠的組件,膳食補(bǔ)充劑,或接觸面制造或暴露,有毒物質(zhì) , 除非這些材料是必要的 , 因?yàn)槿缦拢?(i) To maintain clean and sanitary conditions。 and (1)您必須保持您在清潔和衛(wèi)生情況的綠化植物。 and (4)有適當(dāng)經(jīng)營(yíng)廢物處理和排放系統(tǒng) , 使它們不構(gòu)成面源污染情況組件,膳食補(bǔ)充劑,或接觸面接觸。 (2)保持道路,庭院,停車場(chǎng) , 使他們不構(gòu)成面源污染情況組件,膳食補(bǔ)充劑,或接觸面接觸。 You must keep the grounds of your physical plant in a condition that protects against the contamination of ponents, dietary supplements, or contact surfaces. 你必須保持一個(gè)條件 , 對(duì)組件的污染保護(hù),膳食補(bǔ)充劑,或聯(lián)絡(luò)您的身體植物表面的理由。 and (1)書面程序履行本附B的要求。 (b) Each supervisor whom you use must be qualified by education, training, or experience to supervise. (二)每個(gè)主管人必須為您使用合格的教育,培訓(xùn),監(jiān)督或經(jīng)驗(yàn)。 (c) Each person engaged in manufacturing, packaging, labeling, or holding, or in performing any quality control operations, must have the education, training, or experience to perform the person39。 Sec. 秒。 (七)不儲(chǔ)存在那里組成部分,膳食補(bǔ)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(gè)人財(cái)物。 該手套必須是一個(gè)防滲材料。 If hand jewelry cannot be removed, it must be covered by material that is maintained in an intact, clean, and sanitary condition and that effectively protects against contamination of ponents, dietary supplements, or contact surfaces。 and (i)在開始工作。 (1)穿著的方式 , 對(duì)部分污染的保護(hù)外衣,膳食補(bǔ)充劑,或任何接觸面。及 (2) Instructing your employees to notify their 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 ponents, 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(gè)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(bǔ)充劑,或任何接觸面。 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 ponents, dietary supplements, 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(dòng) , 任何人可能是誰(shuí)微生物污染的來(lái)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(bǔ)充劑,并在接觸面用于制造包裝,標(biāo)簽,或膳食補(bǔ)充劑舉行。 Subpart BPersonnel 部分B 人事 Sec. 秒。 We means the US Food and Drug Administration (FDA). 我們指美國(guó)食品及藥物管理局(FDA)。 Reserve sample means a representative sample of product that is held for a designated period of time. 儲(chǔ)備樣本指產(chǎn)品 , 在一段時(shí)間指定期間舉行的代表性。 Quality control means a planned and systematic operation or procedure for ensuring the quality of a dietary supplement. 質(zhì)量控制手段 , 有計(jì)劃和有系統(tǒng)的運(yùn)作 , 確保膳食補(bǔ)充劑的質(zhì)量或程序。 Physical plant means all or any part of a building or faci
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