美国良好操作规范(GMP—21CFR_Part_110,参考译文)

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【实用文档】良好操作规范GMP

第三章良好生产规范（GMP）人们有权利期望所食用的食品是安全的和适宜的，但食源性疾病导致对人们的伤害，甚至带来不幸，则是大家都不愿看到的。

为满足人们日益增长的期望，保证所食用的食品是安全和适宜的，避免由于食源性疾病、食源性伤害和食品腐败给人们身体健康带来的损害及其造成经济损失，食品法典委员会（CAC）于1969年颁布了《食品卫生通则》（Codex General Principle of Food Hygiene），随后又经过三次修订。

通则对食品的初级生产、加工厂设计和设施、生产控制、工厂养护与卫生、工厂个人卫生、运输等作了规定。

各国政府以CAC的《食品卫生通则》为基本框架并结合本国的一些实际情况，分别制定了相关的法律法规，以达到对食品卫生进行有效控制的目的。

良好生产规范GMP是英文Good Manufacturing Practice的缩写，是指政府制定颁布的强制性的有关食品原料、生产加工、包装、贮存、运输、人员等的卫生要求。

它规定了食品生产必须满足的卫生条件，因此也可以说它是食品生产企业所必须满足的卫生标准。

由于食品GMP的提法诞生于美国，并被批准为法规（21CFR part 110），故我们就将类似内容的法规称为GMP法规。

第一节良好生产规范（GMP）的发展良好生产规范（GMP）在二十世纪六十年代产生于美国，先是美国FDA制定药品的GMP，为保证药品的质量，强制要求药品生产厂必须达到其要求，如厂房设施、机构人员、设备、物料、生产卫生管理、质量管理、销售回收、投诉等等。

1969年CAC公布了《食品卫生通则》（CAC/RCP 1-1969），随后在1985年、1997年和1999年做了修改。

1969年美国公布了食品GMP基本法规（21CFR Part 110）。

从1969—1999年CAC公布了42个各类食品的卫生技术规范。

1975年日本厚生省开始制定各类食品卫生规范。

美国FDA在21CFR part 110法规之后又相继制定了各类食品的操作规范，如21CFR part 106适用于婴儿食品的营养品质控制；21CFR part 113适用于低酸罐头食品加工企业；21CFR part 114适用于酸化食品加工企业等等。

美国FDA21CFR110部分关于食品生产企业现行良好操作规范

美国FDA 21 CFR 第110部分关于食品生产企业现行良好操作规范(GMP)法规汇总美国GMP（21 CFR part 110）法规适用于所有食品，作为食品的生产、包装、贮藏卫生品质管理体制的技术基础，具有法律上的强制性。

以下内容即为21 CFR part 110 法规汇总。

A分部—总则§110.3 现行的良好操作规范的定义（Definitions）§110.5 现行的良好操作规范（Current good manufacturing practice）§110.10 现行良好操作规范的操作人员（Personnel）§110.19 现行良好操作规范的例外情况（Exclusions）B分部-建筑物与设施§110.20 食品生产加工企业的厂房与地面（Plant and grounds）§110.35 食品生产加工企业的卫生操作（Sanitary operations）§110.37 食品生产加工企业的卫生设施及控制（Sanitary facilities and controls）C 分部—设备§110.40 食品生产加工企业的设备及器具（Equipment and utensils）D分部—预留作将来补充E分部-生产加工控制§110.80 食品生产加工及控制（Processes and controls）§110.93 食品成品的仓储与销售（Warehousing and distribution）F分部-预留作将来补充G部分-缺陷水平§110.110 供人食用的食品中对健康无危害的、天然的、不可避免的缺陷（Natural or unavoidable defects in food for human use that present no health hazard）§110.3 现行的良好操作规范的定义(Definitions) 110.3 定义联邦食品、药物及化妆品条例（以下简称条例）第201节中术语的定义和解释适用于本部分的同类术语。

美国良好操作规范(GMP—21CFRPart111)之欧阳家百创编

[联邦法规]欧阳家百（2021.03.07）[Title 21, Volume 2] [标题21，第2卷][Revised as of April 1, 2008] [日期为2008年4月1日][CITE: 21CFR111] [引用：21CFR111]TITLE 21--FOOD AND DRUGS 标题21 -食品和药物CHAPTER I--FOOD AND DRUG ADMINISTRATION 第一章-食品和药物管理局DEPARTMENT OF HEALTH AND HUMAN SERVICES 部卫生与公众服务SUBCHAPTER B--FOOD FOR HUMAN CONSUMPTION 子章节B 组-人类食用的食物PART 111 第111 CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS 现行良好操作规范在制造，包装，标签，或对食品补充剂控股作业Subpart A--General Provisions 子部分-一般规定Sec. 秒。

111.1 Who is subject to this part? 111.1谁是受这部分？(a) Except as provided by 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（二本节），你必须遵守，如果你这部分的制造，包装，标签，或持有饮食的补充，其中包括：(1) A dietary supplement you manufacture but that is packaged or labeled by another person; and （1）膳食补充剂，但你制造的包装物或由他人标记;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）膳食补充剂进口或在任何国家或美国境内的进口提供，哥伦比亚特区，或波多黎各联邦。

良好操作规范GMP

G o o d
M a n u f a c t u r i n g
P r a c t i c e
CAC有关卫生实施法规
第二节 CAC 有关卫生实施法规
5、生产控制目标：通过食品危害控制，生产安全的和适宜人们消费的食品。 -食品的危害控制：实施控制、监测、验证； - 安全卫生控制关键：时间和温度；其它加工工艺；微生物交叉污染；物理和化学污染

食品企业通用卫生规范 GB14881-1994 饮料企业良好生产规范 GB12695-2003 出口饮料生产企业卫生注册规范 GB/T22000-2006食品安全管理体系食品链中各类组织的要求 GB/T27305-2008食品安全管理体系果汁和蔬菜汁类生产企业要求

GMP一般情况下，它以法规、推荐性法案、条例和准则等形式公布。企业为了更好地执行GMP的规定，可以结合本企业的加工品种和工艺特点，在不违背法规性 GMP的基础上制定自己的良好加工指导文件。
CAC有关卫生实施法规
第二节 CAC 有关卫生实施法规
7、工厂：个人卫生目标：通过保持适当的个人清洁及适当的工作方法，保证生产人员不污染食品。 -健康状况； -疾病和受伤； -个人清洁； -个人举止； -参观者。
CAC有关卫生实施法规
第二节 CAC 有关卫生实施法规
G o o d
M a n u f a c t u r i n g
P r a c t i c e
第一节良好操作规范发展简介

21 21
CFR CFR
part part
106 113
适用于婴儿食品的营养品质控制适用于低酸罐头食品加工企业

21 CFR part110-美国FDA食品生产企业GMP

美国FDA食品生产企业GMP（良好操作规范）法规（21 CFR part110）A 总则§110.3定义联邦食品、药物及化妆品法（以下简称该法案）第210节中术语的定义和解释适用于本法规的同类术语，下列定义亦同样适用：（a）酸性食品或酸化食品（Acid foods or acidified foods）：平衡pH值等于或低于4.6的食品。

（b）适当的（Adequate）为完成良好公共卫生规范的预定目标所需要的要求。

（c）面糊（Batter）：一种半流体物质，通常包含面粉和其它成分。

可在其中浸蘸食品的主要成分，或用它涂在外表，或直接用它制成焙烤食品。

（d）烫漂（Blanching）：在包装前对食品（不包括树生坚果和花生）进行热处理，使天然酶部分或完全失活，并使该食品发生物理或生化的变化。

（e）关键控制点（Critical control point）：食品加工过程中的一个点，若该点控制不当，极可能造成、引发或导致危害，或导致成品污染，或导致成品分解。

（f）食品（Food）：指210法案（f）节所定义的食品，包括各种原料和配料。

（g）食品接触面（Food contact surfaces）：接触食品的那些表面以及经常在正常加工过程中会将污水滴溅在食品上或溅在接触食品的那些表面上的表面。

“食品接触面”包括用具及接触食品的设备表面。

（h）批（Lot）：在某一时间段内生产的用具体编号标记的食品。

（i）微生物（Microorganisms）：酵母菌、霉菌、细菌和病毒，并包括但不限于对公众健康产生影响的那些微生物种类。

“不良微生物（undesirable microorganisms）”包括那些对公众健康产生显著影响的微生物，会使食品分解的微生物，会使食品受到杂质污染的微生物，或使食品成为该法案所指的掺杂食品的微生物。

在某些情况下，美国FDA在这些法规中使用形容词“微生物的（microbial）”，替代包含“微生物（microorganism）”的形容词短语。

FDA GMP 21CFR Part110 介绍及应用(精选PPT)

然而，如果有必要将这些例外的作业纳入规范，食品与药品管理局会颁布特别的法规。
19
Ｂ分部—建筑物与设施
110.30 厂房与场地场地 1.放置好设备，消除垃圾和废料，铲除厂房及其构
造物近处可能成为害虫所喜爱的孽生地或藏身处的杂草。 2.管理好道路、院落和停车场，使其不至成为能接触食品的区域的污染源。 3.凡是会造成渗漏、鞋上的脏物或害虫孽生地而可能污染食品的区域，要把水排干净。 4.管理好废物处理系统，使其不至成为食品裸露区域的污染源。
11
A 分部—总则
110.10 人员（1）疾病控制（FDA要求的第七个SCP）
体检（患有碍食品卫生的传染病如痢疾、伤寒、病毒性肝炎、活动期肺结核、化脓性或者渗出性皮肤病）监督人员观察（外伤、感冒等；外来人员健康登记）必须教育职工，发现情况，要向上司报告。
12
110.10 人员
品接触面或食品包装材料受到潜在危害。可以通过完善的食品安全管理及操作规范
或有效的设计，包括将可能发生污染的不同作业分开(可采用以下一种或数种手段：地点、时间、隔墙、气流、封闭的操作系统或其它有效方法）。
22
110.30 厂房与场地
3.对露天里发酵容器中的散装食品，可以采用以下任何一种有效的保护手段：
16
110.10 人员
2、规定洗手及消毒的时间在接触到除已清洁的手和胳膊暴露部分以外
的人体暴露部分之后咳嗽、打喷嚏、用完手绢或处理过卫生纸、
吸烟后、吃完东西或喝完饮料之后食品预处理期间，若经常需要去除赃物及污
染物以及在交换工作时，要防止交叉污染在处理完脏的设备和工器具后
17
110.10 人员
（2）清洁卫生（FDA 要求的第4个SCP）

CFR110+关于食品生产企业现行良好操作规范

美国FDA21CFR第110部分关于食品生产企业现行良好操作规范(GMP)法规汇总美国GMP（21CFR part110）法规适用于所有食品，作为食品的生产、包装、贮藏卫生品质管理体制的技术基础，具有法律上的强制性。

以下内容即为21CFR part110法规汇总。

A分部—总则§110.3现行的良好操作规范的定义（Definitions）§110.5现行的良好操作规范（Current good manufacturing practice）§110.10现行良好操作规范的操作人员（Personnel）§110.19现行良好操作规范的例外情况（Exclusions）B分部-建筑物与设施§110.20食品生产加工企业的厂房与地面（Plant and grounds）§110.35食品生产加工企业的卫生操作（Sanitary operations）§110.37食品生产加工企业的卫生设施及控制（Sanitary facilities and controls）C分部—设备§110.40食品生产加工企业的设备及器具（Equipment and utensils）D分部—预留作将来补充E分部-生产加工控制§110.80食品生产加工及控制（Processes and controls）§110.93食品成品的仓储与销售（Warehousing and distribution）F分部-预留作将来补充G部分-缺陷水平§110.110供人食用的食品中对健康无危害的、天然的、不可避免的缺陷（Natural or unavoidable defects in food for human use that present no health hazard）§110.3现行的良好操作规范的定义(Definitions) 110.3定义联邦食品、药物及化妆品条例（以下简称条例）第201节中术语的定义和解释适用于本部分的同类术语。

食品卫生通则(GMP)

23
《食品卫生通则》讲解
2.2 使用本文件各节就有关食品的安全性和适宜性问题不仅对其应达到的目的进行了说明,而且还对这些目标的基本原理加以说明。下面的第3节内容是有关初级生产及其相关过程的。不同食品的卫生规范可能差别较大,而且根据情况应使用具体的细则,因此本节仅是一个总的指导。后面的第4至第10节制定了应用于食物链中销售点以前的总的卫生原则；而第9节还包括有关消费者信息的内容,以使消费者认识到自己在保证食品的安全性和适宜性方面的重要责任。
7
良好操作规范（GMP）简介
中国GMP 卫生注册/登记－出口企业出口资格） 2002版《出口食品生产企业卫生要求》特点：
采用了世界上先进的管理理论和方法强调建立体系突出机构、人员的作用硬件软件要求关健要求“有效控制原则” 有毒有害化学物品控制原则保证体系有效进行的手段传统工艺的额外条款
10
我国良好操作规范体系
食品卫生法
《中华人民共和国工业产品生产许可证管理条例》
各类食品卫生管理办法
《食品生产加工企业质量安全监督管理实施细则（试行）》
食品企业通用卫生规范 GB14881-1994
商检法动植物检疫法
卫生检疫法
出口食品生产企业卫生要求
各类产品生产许可证审查细则
生产许可证
25
《食品卫生通则》讲解
2.3 定义危害：可能对健康产生有害影响的食品中的生物、化学或物理因子； HACCP：对食品安全性可能产生显著影响的危害进行识别、评定和控制的体系；食品处理者：任何与包装或非包装食品、食品设备和器具或者食品表面直接接触,并因此要遵守食品卫生要求的人；食品安全性：当根据食品的用途进行烹调或食用时,食品不会对消费者带来损害的保证；食品的适宜性：根据食品的预期用途,食品可以被人们接受的保证；初级生产：食品链中诸如收获、屠宰、挤奶、捕获等前期的的操作环节。

21 CFR Part 110 - 在制造、包装或者保存人类食品中的现行良好制造规范GMP's on foods

[Code of Federal Regulations][Title 21, Volume 2][Revised as of April 1, 2015][CITE: 21CFR110]TITLE 21--FOOD AND DRUGSCHAPTER I--FOOD AND DRUG ADMINISTRATIONDEPARTMENT OF HEALTH AND HUMAN SERVICESSUBCHAPTER B--FOOD FOR HUMAN CONSUMPTIONPART 110 CURRENT GOOD MANUFACTURING PRACTICEIN MANUFACTURING, PACKING, ORHOLDING HUMAN FOODSubpart A--General ProvisionsSec. 110.3 Definitions.The definitions and interpretations of terms in section 201 of the Federal Food, Drug, and Cosmetic Act (the act) are applicable to such terms when used in this part. The following definitions shall also apply:(a) Acid foods or acidified foods means foods that have an equilibrium pH of 4.6 or below.(b) Adequate means that which is needed to accomplish the intended purpose in keeping with good public health practice.(c) Batter means a semifluid substance, usually composed of flour and other ingredients, into which principal components of food are dipped or with which they are coated, or which may be used directly to form bakery foods.(d) Blanching,except for tree nuts and peanuts, means a prepackaging heat treatment of foodstuffs for a sufficient time and at a sufficient temperature to partially or completely inactivate the naturally occurring enzymes and to effect other physical or biochemical changes in the food.(e) Critical control point means a point in a food process where thereis a high probability that improper control may cause, allow, or contribute to a hazard or to filth in the final food or decomposition of the final food.(f) Food means food as defined in section 201(f) of the act and includes raw materials and ingredients.(g) Food-contact surfaces are those surfaces that contact human food and those surfaces from which drainage onto the food or onto surfaces that contact the food ordinarily occurs during the normal course of operations. "Food-contact surfaces" includes utensils and food-contact surfaces of equipment.(h) Lot means the food produced during a period of time indicated by a specific code.(i) Microorganisms means yeasts, molds, bacteria, and viruses and includes, but is not limited to, species having public health significance. The term "undesirable microorganisms" includes those microorganisms that are of public health significance, that subject food to decomposition, that indicate that food is contaminated with filth, or that otherwise may cause food to be adulterated within the meaning of the act. Occasionally in these regulations, FDA used the adjective "microbial" instead of using an adjectival phrase containing the word microorganism.(j) Pest refers to any objectionable animals or insects including, but not limited to, birds, rodents, flies, and larvae.(k) Plant means the building or facility or parts thereof, used for or in connection with the manufacturing, packaging, labeling, or holding of human food.(l) Quality control operation means a planned and systematic procedure for taking all actions necessary to prevent food from being adulterated within the meaning of the act.(m) Rework means clean, unadulterated food that has been removed from processing for reasons other than insanitary conditions or that hasbeen successfully reconditioned by reprocessing and that is suitable for use as food.(n) Safe-moisture level is a level of moisture low enough to prevent the growth of undesirable microorganisms in the finished product under the intended conditions of manufacturing, storage, and distribution. The maximum safe moisture level for a food is based on its water activity (aw). An aw will be considered safe for a food if adequate data are available that demonstrate that the food at or below the given aw will not support the growth of undesirable microorganisms.(o) Sanitize means to adequately treat food-contact surfaces by a process that is effective in destroying vegetative cells of microorganisms of public health significance, and in substantially reducing numbers of other undesirable microorganisms, but without adversely affecting the product or its safety for the consumer.(p) Shall is used to state mandatory requirements.(q) Should is used to state recommended or advisory procedures or identify recommended equipment.(r) Water activity (aw) is a measure of the free moisture in a food and is the quotient of the water vapor pressure of the substance divided by the vapor pressure of pure water at the same temperature.Sec. 110.5 Current good manufacturing practice.(a) The criteria and definitions in this part shall apply in determining whether a food is adulterated (1) within the meaning of section 402(a)(3) of the act in that the food has been manufactured under such conditions that it is unfit for food; or (2) within the meaning of section 402(a)(4) of the act in that the food has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. The criteria and definitions in this part also apply in determining whether a food is in violation of section 361 of the Public Health Service Act(42 U.S.C. 264).(b) Food covered by specific current good manufacturing practice regulations also is subject to the requirements of those regulations.Sec. 110.10 Personnel.The plant management shall take all reasonable measures and precautions to ensure the following:(a) Disease control. Any person who, by medical examination or supervisory observation, is shown to have, or appears to have, an illness, open lesion, including boils, sores, or infected wounds, or any other abnormal source of microbial contamination by which there is a reasonable possibility of food, food-contact surfaces, orfood-packaging materials becoming contaminated, shall be excluded from any operations which may be expected to result in such contamination until the condition is corrected. Personnel shall be instructed to report such health conditions to their supervisors.(b) Cleanliness. All persons working in direct contact with food, food-contact surfaces, and food-packaging materials shall conform to hygienic practices while on duty to the extent necessary to protect against contamination of food. The methods for maintaining cleanliness include, but are not limited to:(1) Wearing outer garments suitable to the operation in a manner that protects against the contamination of food, food-contact surfaces, or food-packaging materials.(2) Maintaining adequate personal cleanliness.(3) Washing hands thoroughly (and sanitizing if necessary to protect against contamination with undesirable microorganisms) in an adequate hand-washing facility before starting work, after each absence from the work station, and at any other time when the hands may have become soiled or contaminated.(4) Removing all unsecured jewelry and other objects that might fall into food, equipment, or containers, and removing hand jewelry that cannot be adequately sanitized during periods in which food is manipulated by hand. If such hand jewelry cannot be removed, it may be covered by material which can be maintained in an intact, clean, and sanitary condition and which effectively protects against the contamination by these objects of the food, food-contact surfaces, or food-packaging materials.(5) Maintaining gloves, if they are used in food handling, in an intact, clean, and sanitary condition. The gloves should be of an impermeable material.(6) Wearing, where appropriate, in an effective manner, hair nets, headbands, caps, beard covers, or other effective hair restraints.(7) Storing clothing or other personal belongings in areas other than where food is exposed or where equipment or utensils are washed.(8) Confining the following to areas other than where food may be exposed or where equipment or utensils are washed: eating food, chewing gum, drinking beverages, or using tobacco.(9) Taking any other necessary precautions to protect against contamination of food, food-contact surfaces, or food-packaging materials with microorganisms or foreign substances including, but not limited to, perspiration, hair, cosmetics, tobacco, chemicals, and medicines applied to the skin.(c) Education and training. Personnel responsible for identifying sanitation failures or food contamination should have a background of education or experience, or a combination thereof, to provide a level of competency necessary for production of clean and safe food. Food handlers and supervisors should receive appropriate training in proper food handling techniques and food-protection principles and should be informed of the danger of poor personal hygiene and insanitary practices.(d) Supervision. Responsibility for assuring compliance by allpersonnel with all requirements of this part shall be clearly assigned to competent supervisory personnel.[51 FR 22475, June 19, 1986, as amended at 54 FR 24892, June 12, 1989] Sec. 110.19 Exclusions.(a) The following operations are not subject to this part: Establishments engaged solely in the harvesting, storage, or distribution of one or more "raw agricultural commodities," as defined in section 201(r) of the act, which are ordinarily cleaned, prepared, treated, or otherwise processed before being marketed to the consuming public.(b) FDA, however, will issue special regulations if it is necessary to cover these excluded operations.Subpart B--Buildings and FacilitiesSec. 110.20 Plant and grounds.(a) Grounds. The grounds about a food plant under the control of the operator shall be kept in a condition that will protect against the contamination of food. The methods for adequate maintenance of grounds include, but are not limited to:(1) Properly storing equipment, removing litter and waste, and cutting weeds or grass within the immediate vicinity of the plant buildings or structures that may constitute an attractant, breeding place, or harborage for pests.(2) Maintaining roads, yards, and parking lots so that they do not constitute a source of contamination in areas where food is exposed.(3) Adequately draining areas that may contribute contamination to food by seepage, foot-borne filth, or providing a breeding place for pests.(4) Operating systems for waste treatment and disposal in an adequate manner so that they do not constitute a source of contamination in areaswhere food is exposed.If the plant grounds are bordered by grounds not under the operator's control and not maintained in the manner described in paragraph (a) (1) through (3) of this section, care shall be exercised in the plant by inspection, extermination, or other means to exclude pests, dirt, and filth that may be a source of food contamination.(b) Plant construction and design.Plant buildings and structures shall be suitable in size, construction, and design to facilitate maintenance and sanitary operations for food-manufacturing purposes. The plant and facilities shall:(1) Provide sufficient space for such placement of equipment and storage of materials as is necessary for the maintenance of sanitary operations and the production of safe food.(2) Permit the taking of proper precautions to reduce the potential for contamination of food, food-contact surfaces, or food-packaging materials with microorganisms, chemicals, filth, or other extraneous material. The potential for contamination may be reduced by adequate food safety controls and operating practices or effective design, including the separation of operations in which contamination is likely to occur, by one or more of the following means: location, time, partition, air flow, enclosed systems, or other effective means.(3) Permit the taking of proper precautions to protect food in outdoor bulk fermentation vessels by any effective means, including:(i) Using protective coverings.(ii) Controlling areas over and around the vessels to eliminate harborages for pests.(iii) Checking on a regular basis for pests and pest infestation.(iv) Skimming the fermentation vessels, as necessary.(4) Be constructed in such a manner that floors, walls, and ceilingsmay be adequately cleaned and kept clean and kept in good repair; that drip or condensate from fixtures, ducts and pipes does not contaminate food, food-contact surfaces, or food-packaging materials; and that aisles or working spaces are provided between equipment and walls and are adequately unobstructed and of adequate width to permit employees to perform their duties and to protect against contaminating food or food-contact surfaces with clothing or personal contact.(5) Provide adequate lighting in hand-washing areas, dressing and locker rooms, and toilet rooms and in all areas where food is examined, processed, or stored and where equipment or utensils are cleaned; and provide safety-type light bulbs, fixtures, skylights, or other glass suspended over exposed food in any step of preparation or otherwise protect against food contamination in case of glass breakage.(6) Provide adequate ventilation or control equipment to minimize odors and vapors (including steam and noxious fumes) in areas where they may contaminate food; and locate and operate fans and other air-blowing equipment in a manner that minimizes the potential for contaminating food, food-packaging materials, and food-contact surfaces.(7) Provide, where necessary, adequate screening or other protection against pests.Sec. 110.35 Sanitary operations.(a) General maintenance. Buildings, fixtures, and other physical facilities of the plant shall be maintained in a sanitary condition and shall be kept in repair sufficient to prevent food from becoming adulterated within the meaning of the act. Cleaning and sanitizing of utensils and equipment shall be conducted in a manner that protects against contamination of food, food-contact surfaces, orfood-packaging materials.(b) Substances used in cleaning and sanitizing; storage of toxic materials. (1) Cleaning compounds and sanitizing agents used in cleaning and sanitizing procedures shall be free from undesirable microorganisms and shall be safe and adequate under the conditions ofuse. Compliance with this requirement may be verified by any effective means including purchase of these substances under a supplier's guarantee or certification, or examination of these substances for contamination. Only the following toxic materials may be used or stored in a plant where food is processed or exposed:(i) Those required to maintain clean and sanitary conditions;(ii) Those necessary for use in laboratory testing procedures;(iii) Those necessary for plant and equipment maintenance and operation; and(iv) Those necessary for use in the plant's operations.(2) Toxic cleaning compounds, sanitizing agents, and pesticide chemicals shall be identified, held, and stored in a manner that protects against contamination of food, food-contact surfaces, orfood-packaging materials. All relevant regulations promulgated by other Federal, State, and local government agencies for the application, use, or holding of these products should be followed.(c) Pest control.No pests shall be allowed in any area of a food plant. Guard or guide dogs may be allowed in some areas of a plant if the presence of the dogs is unlikely to result in contamination of food, food-contact surfaces, or food-packaging materials. Effective measures shall be taken to exclude pests from the processing areas and to protect against the contamination of food on the premises by pests. The use of insecticides or rodenticides is permitted only under precautions and restrictions that will protect against the contamination of food, food-contact surfaces, and food-packaging materials.(d) Sanitation of food-contact surfaces. All food-contact surfaces, including utensils and food-contact surfaces of equipment, shall be cleaned as frequently as necessary to protect against contamination of food.(1) Food-contact surfaces used for manufacturing or holdinglow-moisture food shall be in a dry, sanitary condition at the timeof use. When the surfaces are wet-cleaned, they shall, when necessary, be sanitized and thoroughly dried before subsequent use.(2) In wet processing, when cleaning is necessary to protect against the introduction of microorganisms into food, all food-contact surfaces shall be cleaned and sanitized before use and after any interruption during which the food-contact surfaces may have become contaminated. Where equipment and utensils are used in a continuous production operation, the utensils and food-contact surfaces of the equipment shall be cleaned and sanitized as necessary.(3) Non-food-contact surfaces of equipment used in the operation of food plants should be cleaned as frequently as necessary to protect against contamination of food.(4) Single-service articles (such as utensils intended for one-time use, paper cups, and paper towels) should be stored in appropriate containers and shall be handled, dispensed, used, and disposed of in a manner that protects against contamination of food or food-contact surfaces.(5) Sanitizing agents shall be adequate and safe under conditions of use. Any facility, procedure, or machine is acceptable for cleaning and sanitizing equipment and utensils if it is established that the facility, procedure, or machine will routinely render equipment and utensils clean and provide adequate cleaning and sanitizing treatment.(e) Storage and handling of cleaned portable equipment and utensils. Cleaned and sanitized portable equipment with food-contact surfaces and utensils should be stored in a location and manner that protects food-contact surfaces from contamination.[51 FR 22475, June 19, 1986, as amended at 54 FR 24892, June 12, 1989] Sec. 110.37 Sanitary facilities and controls.Each plant shall be equipped with adequate sanitary facilities andaccommodations including, but not limited to:(a) Water supply.The water supply shall be sufficient for the operations intended and shall be derived from an adequate source. Any water that contacts food or food-contact surfaces shall be safe and of adequate sanitary quality. Running water at a suitable temperature, and under pressure as needed, shall be provided in all areas where required for the processing of food, for the cleaning of equipment, utensils, and food-packaging materials, or for employee sanitary facilities.(b) Plumbing. Plumbing shall be of adequate size and design and adequately installed and maintained to:(1) Carry sufficient quantities of water to required locations throughout the plant.(2) Properly convey sewage and liquid disposable waste from the plant.(3) Avoid constituting a source of contamination to food, water supplies, equipment, or utensils or creating an unsanitary condition.(4) Provide adequate floor drainage in all areas where floors are subject to flooding-type cleaning or where normal operations release or discharge water or other liquid waste on the floor.(5) Provide that there is not backflow from, or cross-connection between, piping systems that discharge waste water or sewage and piping systems that carry water for food or food manufacturing.(c) Sewage disposal. Sewage disposal shall be made into an adequate sewerage system or disposed of through other adequate means.(d) Toilet facilities. Each plant shall provide its employees with adequate, readily accessible toilet facilities. Compliance with this requirement may be accomplished by:(1) Maintaining the facilities in a sanitary condition.(2) Keeping the facilities in good repair at all times.(3) Providing self-closing doors.(4) Providing doors that do not open into areas where food is exposed to airborne contamination, except where alternate means have been taken to protect against such contamination (such as double doors or positive air-flow systems).(e) Hand-washing facilities.Hand-washing facilities shall be adequate and convenient and be furnished with running water at a suitable temperature. Compliance with this requirement may be accomplished by providing:(1) Hand-washing and, where appropriate, hand-sanitizing facilities at each location in the plant where good sanitary practices require employees to wash and/or sanitize their hands.(2) Effective hand-cleaning and sanitizing preparations.(3) Sanitary towel service or suitable drying devices.(4) Devices or fixtures, such as water control valves, so designed and constructed to protect against recontamination of clean, sanitized hands.(5) Readily understandable signs directing employees handling unproteced food, unprotected food-packaging materials, of food-contact surfaces to wash and, where appropriate, sanitize their hands before they start work, after each absence from post of duty, and when their hands may have become soiled or contaminated. These signs may be posted in the processing room(s) and in all other areas where employees may handle such food, materials, or surfaces.(6) Refuse receptacles that are constructed and maintained in a manner that protects against contamination of food.(f) Rubbish and offal disposal. Rubbish and any offal shall be so conveyed, stored, and disposed of as to minimize the development of odor, minimize the potential for the waste becoming an attractant and harborage or breeding place for pests, and protect againstcontamination of food, food-contact surfaces, water supplies, and ground surfaces.Subpart C--EquipmentSec. 110.40 Equipment and utensils.(a) All plant equipment and utensils shall be so designed and of such material and workmanship as to be adequately cleanable, and shall be properly maintained. The design, construction, and use of equipment and utensils shall preclude the adulteration of food with lubricants, fuel, metal fragments, contaminated water, or any other contaminants. All equipment should be so installed and maintained as to facilitate the cleaning of the equipment and of all adjacent spaces. Food-contact surfaces shall be corrosion-resistant when in contact with food. They shall be made of nontoxic materials and designed to withstand the environment of their intended use and the action of food, and, if applicable, cleaning compounds and sanitizing agents. Food-contact surfaces shall be maintained to protect food from being contaminated by any source, including unlawful indirect food additives.(b) Seams on food-contact surfaces shall be smoothly bonded or maintained so as to minimize accumulation of food particles, dirt, and organic matter and thus minimize the opportunity for growth of microorganisms.(c) Equipment that is in the manufacturing or food-handling area and that does not come into contact with food shall be so constructed that it can be kept in a clean condition.(d) Holding, conveying, and manufacturing systems, including gravimetric, pneumatic, closed, and automated systems, shall be of a design and construction that enables them to be maintained in an appropriate sanitary condition.(e) Each freezer and cold storage compartment used to store and hold food capable of supporting growth of microorganisms shall be fitted with an indicating thermometer, temperature-measuring device, ortemperature-recording device so installed as to show the temperature accurately within the compartment, and should be fitted with an automatic control for regulating temperature or with an automatic alarm system to indicate a significant temperature change in a manual operation.(f) Instruments and controls used for measuring, regulating, or recording temperatures, pH, acidity, water activity, or other conditions that control or prevent the growth of undesirable microorganisms in food shall be accurate and adequately maintained, and adequate in number for their designated uses.(g) Compressed air or other gases mechanically introduced into food or used to clean food-contact surfaces or equipment shall be treated in such a way that food is not contaminated with unlawful indirect food additives.Subpart D [Reserved]Subpart E--Production and Process ControlsSec. 110.80 Processes and controls.All operations in the receiving, inspecting, transporting, segregating, preparing, manufacturing, packaging, and storing of food shall be conducted in accordance with adequate sanitation principles. Appropriate quality control operations shall be employed to ensure that food is suitable for human consumption and that food-packaging materials are safe and suitable. Overall sanitation of the plant shall be under the supervision of one or more competent individuals assigned responsibility for this function. All reasonable precautions shall be taken to ensure that production procedures do not contribute contamination from any source. Chemical, microbial, orextraneous-material testing procedures shall be used where necessary to identify sanitation failures or possible food contamination. All food that has become contaminated to the extent that it is adulterated within the meaning of the act shall be rejected, or if permissible, treated or processed to eliminate the contamination.(a) Raw materials and other ingredients. (1) Raw materials and other ingredients shall be inspected and segregated or otherwise handled as necessary to ascertain that they are clean and suitable for processing into food and shall be stored under conditions that will protect against contamination and minimize deterioration. Raw materials shall be washed or cleaned as necessary to remove soil or other contamination. Water used for washing, rinsing, or conveying food shall be safe and of adequate sanitary quality. Water may be reused for washing, rinsing, or conveying food if it does not increase the level of contamination of the food. Containers and carriers of raw materials should be inspected on receipt to ensure that their condition has not contributed to the contamination or deterioration of food.(2) Raw materials and other ingredients shall either not contain levels of microorganisms that may produce food poisoning or other disease in humans, or they shall be pasteurized or otherwise treated during manufacturing operations so that they no longer contain levels that would cause the product to be adulterated within the meaning of the act. Compliance with this requirement may be verified by any effective means, including purchasing raw materials and other ingredients under a supplier's guarantee or certification.(3) Raw materials and other ingredients susceptible to contamination with aflatoxin or other natural toxins shall comply with current Food and Drug Administration regulations and action levels for poisonous or deleterious substances before these materials or ingredients are incorporated into finished food. Compliance with this requirement may be accomplished by purchasing raw materials and other ingredients under a supplier's guarantee or certification, or may be verified by analyzing these materials and ingredients for aflatoxins and other natural toxins.(4) Raw materials, other ingredients, and rework susceptible to contamination with pests, undesirable microorganisms, or extraneous material shall comply with applicable Food and Drug Administration regulations and defect action levels for natural or unavoidable defects if a manufacturer wishes to use the materials in manufacturing food. Compliance with this requirement may be verified by any effective means,including purchasing the materials under a supplier's guarantee or certification, or examination of these materials for contamination.(5) Raw materials, other ingredients, and rework shall be held in bulk, or in containers designed and constructed so as to protect against contamination and shall be held at such temperature and relative humidity and in such a manner as to prevent the food from becoming adulterated within the meaning of the act. Material scheduled for rework shall be identified as such.(6) Frozen raw materials and other ingredients shall be kept frozen. If thawing is required prior to use, it shall be done in a manner that prevents the raw materials and other ingredients from becoming adulterated within the meaning of the act.(7) Liquid or dry raw materials and other ingredients received and stored in bulk form shall be held in a manner that protects against contamination.(b) Manufacturing operations.(1) Equipment and utensils and finished food containers shall be maintained in an acceptable condition through appropriate cleaning and sanitizing, as necessary. Insofar as necessary, equipment shall be taken apart for thorough cleaning.(2) All food manufacturing, including packaging and storage, shall be conducted under such conditions and controls as are necessary to minimize the potential for the growth of microorganisms, or for the contamination of food. One way to comply with this requirement is careful monitoring of physical factors such as time, temperature, humidity, aw, pH, pressure, flow rate, and manufacturing operations such as freezing, dehydration, heat processing, acidification, and refrigeration to ensure that mechanical breakdowns, time delays, temperature fluctuations, and other factors do not contribute to the decomposition or contamination of food.(3) Food that can support the rapid growth of undesirable microorganisms, particularly those of public health significance, shall be held in a manner that prevents the food from becoming。

21CFR第110部分的内容要点

（1）人员(110.10)经体检或现场观察发现凡是患有或可能患有有碍食品生产卫生的人员不准进入车间，工厂要告知员工一旦健康不良时要向厂方报告。

从事食品加工的人员必须：•穿着清洁、卫生的工作服•讲究个人卫生•进入车间前、双手弄脏后或间歇复工前均要洗手、消毒•不准佩戴不稳固的饰物和难以充分消毒的戒指类手饰物品•如用手套，则必须清洁、卫生、无破损、不渗水•戴发网、发袋、帽或胡须套，防止毛发污染食品•私人衣物、用品不准存放在加工区内•禁止在加工区内吸烟、吃东西、嚼口香糖、喝饮料•食品及其接触面和包装材料不得受汗水、头发、化妆品、肤用药品的污染或微生物的污染卫生监督员、生产员工要经食品生产卫生、安全培训；工厂要指定胜任监督的人员负责确保所有员工符合卫生要求。

(2)厂房和场地（110．20)工厂的场地必须：•无垃圾、杂物、废旧设备，无杂草，无孳生蝇虫和藏匿鼠类的场所•道路、院落和停车场不会污染食品加工区•场地排水通畅•废水、废物处理不构成对食品加工区的污染厂房的结构、设计必须：•面积与生产能力相适应•能进行有效地隔离，防止生物的、化学的、物理的交叉污染•地板、墙面、天面易于清洁，维护状况良好，设备和管道上的冷凝水不污染食品及其接触面和包装材料，人员通道和设备周围的空间要足够和通畅•人员卫生区、加工区照明充足，采用防爆和安全灯具•车间内排烟气设施充足、良好，排放方向不对食品生产造成污染•装设防蝇虫纱窗等设施(3)操作卫生（110.35）•车间及生产设施清洁卫生，维护状况良好，工器具和设备清洗、消毒对生产不造成污染•清洁剂、消毒剂必须安全、可靠，不含有害微生物•清洁剂、消毒剂、灭虫药剂必须加贴标志，存放和贮存不对生产造成污染•工厂内不得有虫害、鼠害，厂区内养的狗不得对食品生产造成污染，灭虫剂和杀鼠剂使用对生产不造成污染•工器具和设备的食品接触表面必须经常进行清洁，以防止污染——生产低水分食品的食品接触面必须干燥、卫生，如需清洗，必须经消毒、干燥后方可使用；——带水作业时，工器具和设备的食品接触面使用前，必须清洗消毒，如果是连续作业，上述表面必须按需要经常进行清洗消毒；——非食品接触表面必须按需要经常进行清洁或清洗；——一次性用品的贮存和弃置不得对食品接触表面造成污染；——消毒剂必须有效、安全，所采用的清洗和消毒的设备和方法要能保证充分的清洗、消毒效果。

美国FDA食品生产企业GMP(良好操作规范)法规

美国FDA食品生产企业GMP（良好操作规）法规（21 CFR part110）A 总则§110.3定义联邦食品、药物及化妆品法（以下简称该法案）第210节中术语的定义和解释适用于本法规的同类术语，下列定义亦同样适用：（a）酸性食品或酸化食品（Acid foods or acidified foods）：平衡pH值等于或低于4.6的食品。

（b）适当的（Adequate）为完成良好公共卫生规的预定目标所需要的要求。

（c）面糊（Batter）：一种半流体物质，通常包含面粉和其它成分。

可在其中浸蘸食品的主要成分，或用它涂在外表，或直接用它制成焙烤食品。

（d）烫漂（Blanching）：在包装前对食品（不包括树生坚果和花生）进行热处理，使天然酶部分或完全失活，并使该食品发生物理或生化的变化。

（f）食品（Food）：指210法案（f）节所定义的食品，包括各种原料和配料。

（g）食品接触面（Food contact surfaces）：接触食品的那些表面以及经常在正常加工过程中会将污水滴溅在食品上或溅在接触食品的那些表面上的表面。

“食品接触面”包括用具及接触食品的设备表面。

（h）批（Lot）：在某一时间段生产的用具体编号标记的食品。

（i）微生物（Microorganisms）：酵母菌、霉菌、细菌和病毒，并包括但不限于对公众健康产生影响的那些微生物种类。

在某些情况下，美国FDA在这些法规中使用形容词“微生物的（microbial）”，替代包含“微生物（microorganism）”的形容词短语。

21CFR211中英文对照版(SMART)

PART 211 211部分- CURRENT GOOD MANUFACTURING PRACTICE FOR—制剂药品的CGMPFINISHED PHARMACEUTICALSSubpart A--General Provisions A.总则§211.1 - Scope.211∙1范围§211.3 - Definitions.211∙3定义Subpart B--Organization and Personnel B．组织与人员§211.22 - Responsibilities of quality control unit.211∙22质量控制部门的职责§211.25 - Personnel qualifications.211∙25人员资格§211.28 - Personnel responsibilities.211∙28人员职责§211.34 - Consultants.211∙34顾问Subpart C--Buildings and Facilities C．厂房和设施§211.42 - Design and construction features.211∙42设计与建造特征§211.44 - Lighting.211∙44照明§211.46 - Ventilation, air filtration, air heating and211∙46通风、空气过滤、空气加热与冷却§211.48 - Plumbing.211∙48管件§211.50 - Sewage and refuse.211∙50污水和废料§211.52 - Washing and toilet facilities.211∙52洗涤和盥洗设备§211.56 - Sanitation.211∙56卫生§211.58 - Maintenance.211∙58保养Subpart D--Equipment D．设备§211.63 - Equipment design, size, and location.211∙63设备的设计、尺寸及位置§211.65 - Equipment construction.211∙65设备构造§211.67 - Equipment cleaning and maintenance.211∙67设备清洁与保养§211.68 - Automatic, mechanical, and electronic211∙68自动化设备、机械化设备和电子设备equipment.§211.72 - Filters.211∙72过滤器Subpart E--Control of Components and DrugE．成分、药品容器和密封件控制Product Containers and Closures§211.80 - General requirements.211∙80总要求§211.82 - Receipt and storage of untested211∙82未检验的成份、药品容器和密封件的接收与贮存components, drug product containers, and closures.§211.84 - Testing and approval or rejection of211∙84成份、药品容器和密封件的试验、批准或拒收components, drug product containers, and closures.§211.86 - Use of approved components, drug product211∙86获准的成份、药品容器和密封件的使用containers, and closures.§211.87 - Retesting of approved components, drug211∙87获准的成份、药品容器和密封件的复检product containers, and closures.§ 211.89 - Rejected components, drug product211∙89拒收的成份、药品容器和密封件containers, and closures.§ 211.94 - Drug product containers and closures.211∙94药品密封容器和密封件Subpart F--Production and Process Controls F .生产和加工控制§211.100 - Written procedures; deviations.211∙100成文的规程、偏差§211.101 - Charge-in of components.211∙101成分的控制§211.103 - Calculation of yield.211∙103 产量计算§211.105 - Equipment identification.211∙105设备鉴别§211.110 - Sampling and testing of in-process211∙110中间体和药品的取样与检验materials and drug products.§211.111 - Time limitations on production.211∙111生产时间限制§211.113 - Control of microbiological contamination.211∙113微生物污染的控制§211.115 - Reprocessing.211∙115返工Subpart G--Packaging and Labeling Control G.包装和标签控制§211.122 - Materials examination and usage criteria.211∙122材料的检查和使用标准§211.125 - Labeling issuance.211∙125标签的发放§211.130 - Packaging and labeling operations.211∙130包装和贴签操作§211.132 - Tamper-evident packaging requirements211∙132人用非处方药（OTC）保险包装的要求for over-the-counter (OTC) human drug products.§211.134 - Drug product inspection.211∙134药品检查§ 211.137 - Expiration dating.211∙137有效期Subpart H--Holding and Distribution H．贮存和销售§ 211.142 - Warehousing procedures.211∙142入库程序§ 211.150 - Distribution procedures.211∙150销售程序Subpart I--Laboratory Controls I∙实验室控制§ 211.160 - General requirements.211∙160总要求§ 211.165 - Testing and release for distribution.211∙165销售前的检验与发放§ 211.166 - Stability testing.211∙166稳定性试验§211.167 - Special testing requirements.211∙167特别检验要求§ 211.170 - Reserve samples.211∙170留样§ 211.173 - Laboratory animals.211∙173实验动物§ 211.176 - Penicillin contamination.211∙176青霉素污染Subpart J--Records and Reports J．记录和报告§ 211.180 - General requirements.211∙180总要求§ 211.182 - Equipment cleaning and use log.211∙182设备清洁和使用记录§ 211.184 - Component, drug product container,211∙184成份、药品容器、密封件及标签记录closure, and labeling records.§ 211.186 - Master production and control records.211∙186主要生产和控制的记录§ 211.188 - Batch production and control records.211∙188批生产和控制记录§ 211.192 - Production record review.211∙192产品记录复查§ 211.194 - Laboratory records.211∙194实验室记录§ 211.196 - Distribution records.211∙196销售记录§ 211.198 - Complaint files.211∙198客户投诉档案Subpart K--Returned and Salvaged Drug Products K．退货的药品和回收处理§ 211.204 - Returned drug products.211∙204退货的药品§ 211.208 - Drug product salvaging.211∙208 药品的回收利用Subpart A-General Provisions A.总则§ 211.1 Scope211∙1范围(a) The regulations in this part contain the minimum current good manufacturing practice for preparation of drug products for administration to humans or animals.（a）本部分的条例包含人用或兽用药品制备的现行最低限度的药品生产质量管理规范（GMP）(b) The current good manufacturing practice regulations in this chapter, as they pertain to drug products, and in parts 600 through 680 of thischapter, as they pertain to biological products for human use, shall be considered to supplement, not supersede, the regulations in this part unless the regulations explicitly provide otherwise. In the event it is impossible to comply with applicable regulations both in this part and in other parts of this chapter or in parts 600 through 680 of this chapter, the regulation specifically applicable to the drug product in question （b）在本章里的这些针对药品的现行GMP条例和本章600至800的所有部分针对人用生物制品的现行GMP条例，除非明确另有说明者外，应认为是对本部分条例的补充，而是不代替。

美国良好操作规范(GMP—21CFR Part 110,参考译文)

美国良好操作规范（GMP—21CFR Part 110，参考译文）A分部—总则110.3 定义联邦食品、药物及化妆品条例（以下简称条例）第201节中术语的定义和解释适用于本部分的同类术语。

下列定义亦同样适用：1．酸性食品或酸化食品：是指平衡pH值为4.6或低于4.6的食品。

2．适当的：指为达到良好的公共卫生规范的预期目的所需要满足的要求。

3．面糊：是指一种半流体物质，通常包含面粉和其他辅料，食品的主要成分可浸在其中，或用它涂膜，或直接用来形成烘烤的食品。

4．热烫：除坚果和花生外，指在包装前对食品进行足够时间和充分温度的热处理，以使天然形成的酶部分地或完全失活，并使该食品产生物理或生化方面的变化。

5．关键控制点：是指食品加工过程中的一个点，在这个点上控制不当时，就可能造成或导致危害，或使成品受到杂质污染，或造成成品的腐败。

6．食品：指条例201（F）节所定义的食品．包括各种原料和辅料。

7．食品接触面：指与人类食品的接触表面以及在正常加工过程中因污水滴溅污染的并与食品接触的设备和工器具表面。

“食品接触面”包括与食品接触的工器具及设备的表面。

8．批：指在某一段时间生产的由具体代号标记的食品。

9．微生物：是指酵母菌、霉菌、细菌和病毒,包括（但不仅限于）对公众健康有影响的微生物种类。

“有害微生物”这个术语包括对公众健康有影响的，或使食品发酵分解的，或使食品受到杂质污染的、或使食品成为条例所指的劣质食品的微生物。

有时，美国食品与药物管理局在这些法规中使用“微生物”这个词，而不使用包含“微生物”一词的短语。

10．害虫：指令人厌恶的任何动物或昆虫，包括，但不仅限于鸟、啮齿动物、蝇和幼虫。

11．厂房：指用于人类食品加工、包装、标识或存放，或与人类食品的加工、包装、标识或存放有关的建筑物或设施或其中的某些部分。

12．质量控制操作：是指一种有计划的系统操作，并采取一切必要的行动防止食品成为条例所指的劣质食品。

13．返工品：是指由于一些不卫生因素而从加工过程中检选出的、干净的、未被掺杂的食品，或经过重新加工而再次调制，并适于消费的食品。

美国良好操作规范(GMP—21CFRPart111)之欧阳化创编

[联邦法规][Title 21, Volume 2] [标题21，第2卷][Revised as of April 1, 2008] [日期为2008年4月1日][CITE: 21CFR111] [引用：21CFR111]TITLE 21--FOOD AND DRUGS 标题21 -食品和药物CHAPTER I--FOOD AND DRUG ADMINISTRATION 第一章-食品和药物管理局DEPARTMENT OF HEALTH AND HUMAN SERVICES 部卫生与公众服务SUBCHAPTER B--FOOD FOR HUMAN CONSUMPTION 子章节B组-人类食用的食物PART 111 第111 CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS 现行良好操作规范在制造，包装，标签，或对食品补充剂控股作业Subpart A--General Provisions 子部分-一般规定Sec. 秒。

111.1 Who is subject to this part? 111.1谁是受这部分？(a) Except as provided by 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（二本节），你必须遵守，如果你这部分的制造，包装，标签，或持有饮食的补充，其中包括：(1) A dietary supplement you manufacture but that is packaged orlabeled by another person; and （1）膳食补充剂，但你制造的包装物或由他人标记;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）膳食补充剂进口或在任何国家或美国境内的进口提供，哥伦比亚特区，或波多黎各联邦。

美国FDA食品生产企业GMP(良好操作规范)法规doc18

（b）适当的（Adequate）为完成良好公共卫生规范的预定目标所需要的要求。

（c）面糊（Batter）：一种半流体物质，通常包含面粉和其它成分。

可在其中浸蘸食品的主要成分，或用它涂在外表，或直接用它制成焙烤食品。

（d）烫漂（Blanching）：在包装前对食品（不包括树生坚果和花生）进行热处理，使天然酶部分或完全失活，并使该食品发生物理或生化的变化。

（f）食品（Food）：指210法案（f）节所定义的食品，包括各种原料和配料。

（g）食品接触面（Food contact surfaces）：接触食品的那些表面以及经常在正常加工过程中会将污水滴溅在食品上或溅在接触食品的那些表面上的表面。

“食品接触面”包括用具及接触食品的设备表面。

（h）批（Lot）：在某一时间段内生产的用具体编号标记的食品。

（i）微生物（Microorganisms）：酵母菌、霉菌、细菌和病毒，并包括但不限于对公众健康产生影响的那些微生物种类。

在某些情况下，美国FDA在这些法规中使用形容词“微生物的（microbial）”，替代包含“微生物（microorganism）”的形容词短语。

FDA-GMP-21CFR-Part110培训

洗手示例
110.10 人员
2、规定洗手及消毒的时间在接触到除已清洁的手和胳膊暴露部分以外
的人体暴露部分之后咳嗽、打喷嚏、用完手绢或处理过卫生纸、
吸烟后、吃完东西或喝完饮料之后食品预处理期间，若经常需要去除赃物及污
染物以及在交换工作时，要防止交叉污染在处理完脏的设备和工器具后
110.10 人员
工的完整的产品安全计划。没有适当的GMP做基础，工厂量系统设施与设备系统物料系统生产系统包装与标签系统实验室控制系统
FDA SCP (SSOP)控制八大系
NO.1 加工用水和冰的安全 NO.2 食品接触面和清洁度（工器具、手套、工作
保持清洁的方法包括，但不限于： 1、外套 2、个人卫生 3、手部的卫生 4、珠宝饰品和其它饰物的控制。
个人卫生设施
生产场所或生产车间入口处应设置更衣室；必要时特定的作业区入口处可按需要设置更衣室。更衣室应保证工作服与个人服装及其他物品分开放置。
生产车间入口及车间内必要处，应按需设置换鞋（穿戴鞋套）设施或工作鞋靴消毒设施。如设置工作鞋靴消毒设施，其规格尺寸应能满足消毒需要。
SCP是针对GMP的特定几个部分，引入GMP 没有具体规
定的一些新的要求，例如监测、纠正措施、记录等。可以使GMP得到更好的应用。
当已经鉴别的危害是与产品本身或某个单独的加工步骤有关，必须由HACCP来控制。而与加工环境或人员有
关的危害一般有SCP来控制较好。
SCP和GMP是HACCP计划的基础，构成针对具体产品和加
A 分部—总则
110.3 定义 “食品接触面” 指接触人类食品那些表面
以及在正常加工过程中会将污水滴溅在食品上或与食品接触的表面上的那些表面，“食品接触面”包括用具及接触食品的设备的表面。

FDAGMP21CFRPart110介绍及应用精选

16
110.10 人员
? 2、规定洗手及消毒的时间 ? 在接触到除已清洁的手和胳膊暴露部分以外
的人体暴露部分之后 ? 咳嗽、打喷嚏、用完手绢或处理过卫生纸、
吸烟后、吃完东西或喝完饮料之后 ? 食品预处理期间，若经常需要去除赃物及污
染物以及在交换工作时，要防止交叉污染 ? 在处理完脏的设备和工器具后
? A分部－总则 ? B 分部—建筑物与设施
110.30 厂房与场地 110.35 卫生操作 110.37 卫生设施及管理 ? C 分部—设备 110.40 设备与用具 ? D 分部— ( 本节预留作将来补充） ? E 分部—生产及加工管理 110.80 加工及控制 110.93 仓储与分销 ? F 分部— ( 本节预留作将来补充 ) ? G 分部— 缺陷行动水平 ( DEFECT ACTION LEVEL ）
9
A 分部—总则
? “消毒” 是指用一种方法对接触食物的表面进行充分地处理，这种方法能有效地消灭危害公众健康的微生物的细胞，并大量减少其它不良微生物的数量，但对产品及其安全性却无不利的影响。
10
A 分部—总则
? 掺杂食品必须用本部分的标准和定义来确定⑴某种食品是否为该法 402(a)(3) 节意义上的掺杂食品，也就是说这种食品是在不适合生产食品的条件下加工的，或者是⑵该法402(a)(4) 节意义上的食品，就是说该食品是在不卫生的条件下制作、包装或存放的，因而可能已经受到污染，或者已经变得对人体健康有害。
? 然而，如果有必要将这些例外的作业纳入规范，食品与药品管理局会颁布特别的法规。
19
Ｂ分部—建筑物与设施
? 110.30 厂房与场地 ? 场地 ? 1.放置好设备，消除垃圾和废料，铲除厂房及其构

FDA21CFRpart11译文

FDA21CFRpart11译⽂21 CFR Part 11是针对电⼦记录和电⼦签名的FDA法规，对于药⼚和医疗器械使⽤的众多电⼦记录和电⼦签名提供了详尽的要求和规范。

彼得对这部分接触的也不多，在研读过程中将原⽂进⾏了翻译，供⼤家交流和讨论。

A部分—通⽤规定Subpart A--General Provisions11.1 范围Sec. 11.1 Scope.(a) 本部分的法规制定了接受标准，⽤于机构评估电⼦记录、电⼦签名、电⼦记录加⼿写签名的可信性、可靠性，以及通常等同于纸质记录和⼿写签名的形式。

(a) The regulations in this part setforth the criteria under which the agency considers electronic records,electronic signatures, and handwritten signatures executed to electronicrecords to be trustworthy, reliable, and generally equivalent to paper recordsand handwritten signatures executed on paper.(b) 本部分适⽤于根据法规需求制定的，以电⼦形式⽣成、修改、维护、存档、恢复或传输的任何记录。

还适⽤于提交给监管机构的关于联邦⾷品、药品和化妆品以及公共健康服务法案需求的电⼦记录，即使此类记录不是法规中特别提到的。

但是，本部分不适⽤于以电⼦形式传输的纸质记录。

(b) This part applies to records inelectronic form that are created, modified, maintained, archived, retrieved, ortransmitted, under any records requirements set forth in agency regulations.This part also applies to electronic records submitted to the agency underrequirements of the Federal Food, Drug, and Cosmetic Act and the Public HealthService Act, even if such records are not specifically identified in agencyregulations. However, this part does not apply to paper records that are, orhave been, transmitted by electronic means.(c) 当电⼦签名和相关的电⼦记录符合本部分要求时，机构应认可电⼦签名等同于⼿写签名、缩写和其他法规中要求常⽤的签名形式，除⾮是法规⾃1997年8⽉20⽇以来特别强调的情况。