美国良好操作规范(GMP—21CFR_Part_110_参考译文)

合集下载

美国良好操作规范(GMP—21CFRPart111)

[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的进口提供，哥伦比亚特区，或波多黎各联邦。

美国良好操作规范GMP110

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。

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。

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。

2.2.1 美国21CFR第110法规-GMP

美国FDA食品生产企业GMP法规美国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。

（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。

美国cGMP 中英文对照

PART 210 CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL 210部分有关于生产、加工、包装和药品的储存的现行GMP；一般准则Sec. Status of current good manufacturingpractice regulations.cGMP的法规地位。

(a) The regulations set forth in this part and in parts 211 through 226 of this chapter contain the minimum current good manufacturing practice for methods to be used in, and the facilities or controls to be used for, the manufacture, processing, packing, or holding of a drug to assure that such drug meets the requirements of the act as to safety, and has the identity and strength and meets the quality and purity characteristics that it purports or is represented to possess. (a)在本部分及本章第211－226部分中所陈述的法规，为现行GMP最低要求，适用于药品制造、加工、包装或贮存中所采用的方法及所使用的设施或控制手段，以保证该药品符合《联邦食品、药品及化妆品法案》（以下简称法案）对安全性的要求，具有均一性和效价(或含量)并符合或代表其生产过程的质量及纯度等特征。

美国GMP中文稿(CGMP)

GOOD MANUFACTURE PRACTICE 美国药品生产质量管理规范CGMP二三年十二月目录210.1 cGMP法规的地位 2 210.2 cGMP法规的适用性 2 210.3 定义 2 211-A- 总则 4 211-B- 组织与人员 4 211-C- 厂房和设施 5 211-D- 设备7 211-E- 成份药品容器和密封件的控制8 211-F- 生产和加工控制10 211-G- 包装和标签控制11 211-H- 贮存和销售13 211-I- 实验室控制14 211-J- 记录和报告16 211-K- 退回的药品和回收处理20210部分人用及兽用药品的生产加工包装或贮存的CGMP210.1 cGMP法规的地位(a) 在本部分及21CFR 211226部分中陈述的法规是在药品生产加工包装或贮存中使用的现行生产质量管理规范及使用的设施或控制的最低标准以保证该药品符合联邦食品药品及化妆品法对安全性的要求具有均一性和效价(或含量)并符合或代表其生产过程的质量及纯度等特征(b) 凡是在药品生产加工包装或贮存过程中存在任何不符合本部分及21CFR 211226部分中陈述的法规的药品依据联邦食品药品及化妆品法501 (a)(2)-(B)该药应被视为劣药同时导致该事故发生的负责人应受相应的法规的制裁210.2 cGMP法规的适用性(a) 本部分及21CFR 211226适用于普通药品21CFR 600680适用于人用生物制品除非另有明确规定否则上述两者之间应该是相互补充而不是相互取代如有上述两部分的法规不适用的药品则可用特定的具体法规来替代210.3 定义(a) 在联邦食品药品及化妆品法201部分中包含的定义和解释说明适用于21CFR 211 226部分中的术语(b) 下面定义的术语适用于本部分及21CFR 211226(1) 法(Act)指联邦食品药品及化妆品法修订版(21 U.S.C 301 et seq.)(2) 批(Batch)指在规定限度内按照某一生产指令在同一生产周期内生产出来的具有同一性质和质量的一定数量的药品或其它物料(3) 组分(Component)指用于药品生产的所有成份包括那些未在药品中出现的成份(4) 药品(Drug Product)指成品制剂(如片剂胶囊剂口服液等)通常含有一种活性成份并伴有非活性成份(但不是必需的)本术语也包括不含有活性成份但作为安慰剂使用的成品制剂(5) 纤维(Fiber)指长度大于其宽度的3倍的任何微粒状污染物(6) 无纤维脱落的过滤器(Non-fiber-releasing filter)指任何经过适当的预处理(如清洗或冲洗)后不会将纤维脱落到已过滤的组分或药品中的所有过滤器所有含石棉过滤器均被认为是有纤维脱落的过滤器(7) 活性成份(Active Ingredient)是指所有用于保证药物活性或其他在疾病的诊断治愈缓解治疗或预防中起直接作用或影响人或其他动物身体结构或功能的组分本术语包括那些能承受药品生产中的化学变化和为了保证其指定的活性或作用以一种经调整的形式存在于药品中的组分(8) 非活性成份(Inactive ingredient)指不同于活性成份的其他组分(9) 中间产品(In-process material)是指所有经制备复合混合或由化学反应得到的用于药品生产或制备的物料(10)批lot指一批或是一批中特定的均一部分在指定的范围内具有相同的性质和质量或者若为由连续的生产过程制造出的药品批指在单位时间或单位数量生产出的特定的均一的部分并且确保该部分在指定的范围内具有均一性质与质量(11) 批号(Lot number, control number batch number)指由字母数字符号或他们的组合组成由此可确定某批药品或物料的生产加工包装贮存或销售的情况(12) 药品的生产加工包装或贮存(Manufacture, processing, packing, or holding of adrug product)包括药品的包装和标签操作检验质量控制(13) 药用物料(medicated feed)指在21CFR 558.3中定义的B型和C型药用物料该物料含有联邦食品药品及化妆品法201(g)部分中定义的一种或一种以上的药物药用物料的生产应符合21CFR 226部分中的要求(14) 药用预混合料(medicated premix)指21CFR 558.3中定义的A型药用物质该预混合料含有联邦食品药品及化妆品法201(g)部分中定义的一种或一种以上的药物药用预混合料生产应符合21CFR 226部分中的要求(15) 质量控制部门(Quality control unit)指由企业任命负责质量控制相关责任的任何人员或组织机构(16) 含量或效价Strength指() 原料药的浓度(如以重量/重量重量/体积单位剂量/体积为基础)和/(或) () 活性(效价)也即由适当的实验室检测或由足够的临床数据得出的指定的药品治疗活性(如可表达为对照于某标准的单位的术语)(17) 理论产量(Theoretical yield)指在生产加工或包装某种药品的任一适当阶段中并且基于所使用的组分的数量在实际生产中无任何损失或错误的情况下应能生产的数量(18) 实际产量(Actual yield)指某种药品在生产加工包装的任一适当的阶段实际生产出的数量(19) 比率(Percentage of theoretical yield)实际产量(生产加工或包装某种药品的适当阶段)与理论产量(在相同阶段)的比率以百分数表示(20)验收标准(Acceptance criteria)建立在相应的取样方法基础上的药品的质量检验标准和合格不合格标准(如合格质量水平和不合格的质量水平)是决定批准或拒收一批(或其他生产单元的小组)药品的必需因素(21) 代表性样品(Representative sample)指一个样品按合理的标准抽取如随机取样法并包含若干单位元以能保证样品准确描绘被取样品的物料A总则211·1范围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GMPb　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本章其他部分或本章600至680各部分和本部分均可适用的条例前部分的条例可代替本部分条例c　在考虑经提议的发表在1978年9月29日联邦注册表FR上一项免除时若产品及其所有成份是以人用物品形式作一般销售和消费且这些产品根据其预期用途亦可列入药品的范围内则不应对这些非处方药OTC实施本部分条例直至进一步的通知为止本章110部分和113至119部分的条例用于鉴别这些变是食品的OTC药品是否按照GMP的要求生产加工包装和贮存211·3定义本章210·3中的定义适用于本部分B组织与人员211·22质量控制部门的职责a　本部门有批准和拒收所有成份药品包装容器密封件中间体包装材料标签及药品的职责与权力复查生产记录和权力保证不产生差错或若发生差错保证他们充分调查这差错本部门负责根据合同批准或拒收由其它公司生产加工包装或贮存的药品b　适当的实验室检验设备批准或拒收各种成份药品容器密封件包装材料及药品质量控制部门是可以获得的c　本部门有批准或驳回影响药品的均一性效价或含量质量及纯度的所有程序或规格标准的职责d　适用于本部门的职责与程序应成文字材料并应遵循211·25人员资格a　每位从事药品生产加工包装或仓贮工作人员应接受培训教育及有实践经验完成委派的各项职务培训是按照现行GMP包括本章中的现行GMP条例和这些条例要求的成文程序中涉及雇员的内容邀请合格人员指导并连续多次培训保证雇员熟悉现行GMP对他们的要求b　负责监督药品的生产加工包装或仓贮工作的每一个工作人员应受教育培训及有经验完成委派的各项职务以此作为提供药品具有安全性均一性效价或含量质量及纯度的保证c　有足够量招待和监督每种药品的生产加工包装或仓贮的合格人员211·28人员职责a　从事药品生产加工包装或仓贮的人员应穿着适合于其履行职责的清洁衣服按需要头部脸部手部臂部另外罩防止药物受污染b　人员保持良好的个人卫生和健康c　未经监督人员允许其他人员不能进入限制进入的建筑物和设施d　任何人在任何时间明显地表现出现有影响药品安全性和质量的疾病或开放性`损伤应避免接触各种成份药品容器包装设备密封件中间体直至监督人员结对药品有不利影响的健康情况211·34顾问为了对问题提出意见聘请顾问顾问应对药品生产加工包装或仓贮提出建议他们受过足够的教育培训且有丰富的实践经验保留他们的姓名地址任何的顾问资格及服务形式等履历资料C厂房和设施211·42设计与建造特征a　任何用于某类药品生产加工包装或贮存的厂房或建筑群大小适宜结构与位置使其易于清洁保养适合操作b　建筑物有足够空间来有条理地安装设备和放置材料避免不同类的成份药品容器密封件标签中间体或药品等相互混放防止污染通过厂房的上述物料其流向在设计时要防止污染c　操作应在明确规定的大小适中的地区内进行这些地区内进行这些地区按规定各自分隔开以防止污染下列操作须在单独的地区内进行1　发放给生产或包装前质量控制部门取样期间成份药品容器密封件及标签的签收鉴别贮存及拒收2　在处理前拒收的成份药品容器密封件及标签的贮存3　已发放的成份药品容器密封件及标签的贮存4　中间体的贮存5　生产与加工操作6　包装和贴标签操作7　药品发放前的隔离贮存8　发放后药品的贮存9　控制室与实验室操作10无菌操作及有关操作地板墙壁和天花板平滑坚硬表面易清洁温度与湿度控制空气经高效过滤器在正压下过滤层流或非层流均可环境监测系统创造无菌环境房间和设备清洁消毒系统控制无菌环境的设备维修系统d青霉素生产加工及包装设备与生产其他人用药品的设备分开211·44照明所有地区均须提供充足的照明211·46通风空气过滤空气加热与冷却a　提供足够的通风b　提供足够能控制空气正压微生物尘土温度和湿度的设备适应药品生产加工和贮存需要c　空气过滤系统包括预过滤器和微粒物质空气过滤器空气经过滤才送至生产区如果空气是再循环到生产区应测量尘埃含量控制从生产区带来的尘埃在生产区生产中发生空气污染应以排气系统或其他系统充分抽出空气控制污染d　青霉素生产加工和包装的空气输送系统应与其他人用药品的空气输送系统完全分开211·48管件a　在持续正压下应对药品无污染的管道系统内供应饮用水饮用水应符合环境保护机构制订的基本饮用水条例标准40CFR141部分不符合该标准的水不许进入水系统b　排水设备应有足够的大小可直接连接排水管及安装防止虹吸倒流的空气破坏设备或其他机械设备43FR450771978年9月29日修正于48FR114261983年3月18日211·50污水和废料来自水厂和附近建筑物的污水垃圾及其他废料用安全卫生的方法处理211·52洗涤和盥洗设备提供洗涤和盥洗设备包括热冷水肥皂清洁剂空气干燥器或专用毛巾及进入厕所的清洁设备211·56a　所有用作药品生产加工包装及贮存的三房应保持清洁卫生的环境且不受啮齿动物鸟类及其他害虫侵害扰实验动物除外垃圾和有机废料定时以卫生的方法控制处理b　填写分配卫生清洁任务的详细的清洁项目方法设备用于清洁厂房和设施的材料的一览表c　填写适用的杀鼠剂杀昆虫剂杀真菌剂熏蒸剂去垢剂和消毒剂一览表防止这些物品对设备成份药品容器密封件包装材料标签或药品污染除依据联邦杀虫剂杀真菌剂及杀鼠剂法规7U.S.C135已登记和使用的品种外其他的不用211·58保养任何用于药品生产加工包装或贮存的厂保持良好状态D设备211·63设备的设计尺寸及位置药品生产加工包装或贮存设备设计合理大小适当布置合理便于操作清洁和保养211·65设备制造a　设备表面与各种成人中间体或药品接触不产生化学反应和作用保证药品的安全性均一性效价或含量质量或纯度改变b　操作所需之物质如滂沱剂冷却剂等不能进入设备里与成人药品容器封口物品中间体或药品接触保证药品的安全性均一性效价或含量质量或纯度不变211·67设备清洁与保养a　相隔一定时间对设备与工具进行清洁保养和消毒防止出故障与污染影响药品的安全性均一性效价或含量质量或纯度b　制订药品生产加工包装或贮存设备包括用具的清洁和保养文字程序并执行这些程序包括但不一定限于以下内容1　分配清洁保养任务2　保养和清洁细目一览表3　详细说明用于清洁和保养的设备物品和方法拆卸和装配设备的方法必须保证适合清洁和保养的要求4　除去或擦去前批遗留物的鉴定5　已清除了污染的清洁设备的保护6　使用前检查清洁的设备7　保留保养清洁消毒的记录按211·180及211·182的说明检查211·68自动化设备机械化设备和电子设备a　用于药品生产加工包装和贮存的自动化机械化或电子包括计算机或其它类型的设备按惯例对其设计之成文条款作标定检查或核对保证其工作性能良好保留检查标定核对等文字记录b　对保障重要生产变化的计算机或有关系统进行操作培训操作记录或其他记录只能由被认可的人员制订向计算机或有关系统输入或从中输出的各种方案其他记录或资料应核查其准确性输入计算机或关系统内的档案资料除与实验室共同分析计算的结果可消除外其他的应保留文字记录与相应的证明资料一起保存事先设计好的硬件复制品或多各选择系统台复印件磁带或微型胶卷等保证其支持资料正确可靠及完整出现资料改动非人为消除或遗失时应维修211·72过滤器用于生产加工的液体过滤器或人用注射药品的包装材料不许释放出纤维的进入产品除非不得以不在生产加工中使用释放纤维的过滤器或注射药品的包装材料若必须使用一种能释放纤维素的过滤器最后应使用一非释放纷纷物平均最大孔径为0.22μm(如实际生产条件限制可用0.45μm)的附加过滤器过滤降低注射剂内微粒量使用含石板的过滤器最后用或不用特殊非释放纤维过滤器均可以但要根据FDA有关部门提供的该非释放纤维过滤器会或可能损害注射剂的安全性和有效性的证据而定E成分药品容器和密封件控制211·80总要求a　有文字详细说明成份药品容器密封件的签收鉴定贮存装运取样检验和批准或拒收程序并遵循b　成份药品容器和密封件应专人管理和在防止污染的环境下贮存c　药品容器的包装袋或包装箱或密封件应离地面放置保持适当间隔全球清洁和检查d　用明显的已接收的每装货量中的批号代码对成分药品容器或密封件加以鉴别此代码用于记录每批货的放置地方对每批货的情况如隔离批准或拒收等作检查211·82未检验的成份药品容器和密封件的接收与贮存a　接收时和验收前对每个或编组的成份容器药品容器和密封件进行目检给内容物容器损坏或拆封和污染等情况作适当的标志b　成份药品容器各密封件应隔离贮存直至经检验为止合格可发放在符合211·80要求的地区中贮存211·84成份药品容器和封口物品的试验批准或拒收a　每批成份药品容器和封口物品在未经质量部门取样检查合格前不准使用检验合格后发放使用b　收集每批的每一装货量的代表性样品供检验用容数目和每一容器里物质的取样量是有适当的标准的例如成份的变异性统计学标准可信限要求的精密度供应商过去的质量历史21·170要求分析和留样所需的数量等c　收集样品程序1　用适当的方法清洁选出成份容器2　打开容器取样重新封口防止其内容物受污染和其他成分药品容器或密封件的污染3　必要时使用灭菌设备和无菌取样技术4　如果需要从容器顶部中部和底部的成分中取样样品须混合5　鉴定样品容器目的是确定如下资料被取样的材料名称批号被取样的容器取样日期及样品收集人的名字等6　已取样的容器应作标志表示样品已取出d　样品检验程序1　一个药品的每个成分最少做一个特性试验如有专一特性实验就应采用2　依照所有成文的规格标准检验每个成份的纯度含量和质量生产厂家代替上述试验规定生产厂家最少要做个成份特别试验可承认这些成分的供应者扫提供的分析报告规定隔一定时间生产厂家定期验证供应午的试验结果证明供应者的分析结果是正确的3　依照成文规程检验容器和密封件生产厂家代替上友谊赛试验规定生产厂家对这些容器或封口物品最少做一次目检可承认供应者的检验证书规定生产厂家定期验证供应者的试验结果证明其试验结果是正确的4　必要时用显微镜检测成分5　每批易受污物昆虫或其他外来杂物污染的某一成份药品容器或密封件鉴于其预期用途在使用前应做微生物试验e任何批号的成份药品容器或密封件若符合已成文的均一性效价或含量质量纯度等的规格标准和本部分d的有关试验可批准使用任何批号的上述材料不符合这些规格应拒收211·86获准作用的成份药品容器和密封件先入库者先用若产生的偏差是暂时的和适当这种偏差是容许的211·87获准的成份药品容器和密封件的复检经质量控制部门批准或拒收的成份药品容器密封件若长期贮存或曝露在空气热或其他可能对其产生不良影响的环境后应依照211·84对均一性效价或含量质量纯度等复检211·89拒收的成份药品容器和封口物品拒收的成份药品容器和封口物品应经鉴定和在隔离系统下加以控制防止在生产和加工使用211·94药品密封容器和密封件a　药品包装容器和密封件应不起反应不吸着不吸附不致改变药品的安全性均一性含量或效价质量和纯度而超出制定的或其它颁布的规定要求b　容器封口系统应对贮藏和使用过程中可预见的能引起药品变质或污染的外部因素提供足够的防护c　药品容器和密封件应清洁灭菌和除热原保证其适用于预期目的d　药品容器和密封件的标准或规格检验方法指清洁和消毒方法除热原过程应成文并遵循F .生产和加工控制211·100成文的规程偏差a　编写为保证药品的均一性含量或效价质量及纯度而设计的生产和加工控制程序这些程序包括本部内全部要求这些成文程序包括变化须经有关部门起草复查和批准然后再经质量控制部门复查与批准b　在实施各种生产和加工控制功能中遵循已制定的生产和加工控制程序并在招待时以文件加以证明程序中出现的任何偏差应作记录并提出证据211·101成分的进料成文的生产和控制程序包括下面的内容其设计应保证所生产的药品具有核武器原有的均一性含量和效价质量和纯度a　按处方配制的药品保证其活性成份含量不低于100%标示量或规定量b　生产药品用的成份应称量测量或适当粉碎若一种成份从原来容器转移到另一容器内用下列资料以鉴别(1) 成份名称或项目代码(2) 接收或控制号(3) 在新容器中的重量或份量(4) 使用此成分2配制的一批药品包含其产品名称含量和批号c成份的称重测量或粉碎操作应受到严密的监督所盛成份已用于生产的每一容器须经第二人检查保证1　此成份是由质量控制人员发放的2　重量或份量正确批生产记录一致3　容器经严格鉴别d每一成份投料时一人操作另一人核对211·103 产量计算在药品生产加工或贮存的每一适当阶段结束时测算实际产量与理论产量的百分比211·105设备鉴别a　在整个生产周期内同批药品生产使用的全部混合和贮存容器生产线和主要设备应严格识别标示出药品的成份需要时不须标出所处的加工阶段b　一种药品每批生产使用的主要设备以一鉴别性识别号或代号加以识别此鉴别号或代号记录在该批号产品的记录本若生产中只使用一种特殊型号的设备可用该设备名字代替鉴别性识别或代号211·110中间体和药品的取样与检验a　制订和遵循说明每批的加工过程控制及对加工过程中材料的适当样品实行检验或检查的成文程序保证药品的一致性和完整性上述控制程序包括但不限于如下内容1　片剂或胶囊的重量变化2　崩解时间3　充分混和保证均匀4　溶解时间和溶解速率5　溶液的澄明度溶解完全性及PH值b　考虑上述特性而制定的有效中间加工规格与药品最终规格一致此中间加工规格应在以前可靠的加工方法稳定性评估和经应用统计学程序断定认为合适的基础上制定的样品测试保证药品和中间体符合规格标准c　在生产加工期间如在重要阶段的开始由质量控制部门审定决定联取舍d　不合格的中间体在隔离系统下鉴别及控制防止其在征税或加工操作中使用211·111生产时间限制在适当时候制定完成每一生产阶段的时间限制保证药品质量制定的时间限制产生偏差如这些偏差不损害药品质量是可以接受的这些偏差应有文字文件证明是正当的211·113微生物污染的控制a　制订和遵循预防不需消毒药品有害微生物的适当程序b　制订和遵循预防已消毒药品微生物污染的适当程序这些程序包括所有消毒过程的验证211·115返工a　制订和遵循指导人合格批号返工及保证返工批号达标的程序b　没有质量控制部门复检与批准不许进行返工G.包装和标签控制211·122材料的检查和使用标准a　制订详细标签和包装材料的接收鉴别贮存半年取样检验的程序并遵循这些成文程序在接收用于药品包装和贴标签前有代表性地对其取样与检验b　符合成文规格标准的标签和包装材料可批准发放使用不符合规格者不得用于生产c　接收每批不同标签和包装材料无须签收测试无论是接收或拒收须保留其记录d　用于不同药品含量剂型及成份数量的标签和标示材料分别贮存并持上适当牌证只限经核准人员接近贮存地区e　作废和陈旧的标签标示材料及其他包装材料应销毁f　排字印刷在不同药品或同一药品不同规格的品种上`使用排字印刷考虑在印刷期间和印刷后印刷品的设置切裁和管理等应制订包装和标签工作专门控制程序g　在药品印标签的生产线其上的或与其有关的印刷设备应受到临近保证所有印痕与本批产品记录中说明的印痕一致211·125标签的发放a　严格控制已发放的用于药品的标签。

美国药品生产质量管理规范-中英文对照

GOOD MANUFACTURE PRACTICE 美国药品生产质量管理规范（CGMP）二○○三年十二月目录210.1 cGMP法规的地位 (2)210.2 cGMP法规的适用性 (2)210.3 定义 (2)211-A- 总则 (4)211-B- 组织与人员 (4)211-C- 厂房和设施 (5)211-D- 设备 (7)211-E- 成份、药品容器和密封件的控制 (8)211-F- 生产和加工控制 (10)211-G- 包装和标签控制 (11)211-H- 贮存和销售 (13)211-I- 实验室控制 (14)211-J- 记录和报告 (16)211-K- 退回的药品和回收处理 (20)210部分—人用及兽用药品的生产、加工、包装或贮存的CGMPPart 210 - CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL210.1 cGMP法规的地位§ 210.1 Status of current good manufacturing practice regulations.(a) 在本部分及21CFR 211—226部分中陈述的法规是在药品生产、加工、包装或贮存中使用的现行生产质量管理规范及使用的设施或控制的最低标准，以保证该药品符合联邦食品、药品及化妆品法对安全性的要求，具有均一性和效价(或含量)并符合或代表其生产过程的质量及纯度等特征。

(a) The regulations set forth in this part and in Parts 211 through 226 of this chapter contain the minimum current good manufacturing practice for methods to be used in, and the facilities or controls to be used for, the manufacture, processing, packing, or holding of a drug to assure that such drug meets the requirements of the act as to safety, and has the identity and strength and meets the quality and purity characteristics that it purports or is represented to possess.(b) 凡是在药品生产、加工、包装或贮存过程中存在任何不符合本部分及21CFR 211—226部分中陈述的法规的药品，依据联邦食品、药品及化妆品法501 (a)(2)-(B)，该药应被视为劣药，同时导致该事故发生的负责人应受相应的法规的制裁。

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。

美国药品生产质量管理规范-中英文对照

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

新版美国良好操作规范(GMP—21CFRPart111)课件.doc

[联邦法规][Title 21, V olume 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。

FDA GMP 21CFR Part110 介绍及应用

110.35 卫生操作
食品接触面的卫生 (FDA要求的第二个SCP) 1.加工或存放低水分含量食品的食品接触面； 2.湿加工过程中； 3.不与食品接触的设备；如：空调、风扇、制冰
机、移动式的臭氧机等 4.一次性用品(如只用一次的用具、纸杯、纸巾） 5. 消毒方式、清洗后的存放和防护
关于食品接触面的卫生控制（SCP）
适于CIP，可渗入不规则的表面/在设备上可能形成膜或水垢，又被灼烫的危险
关于食品接触面的卫生控制（SCP）
北京防治非典型肺炎联合工作小组发布的《北京防治非典型肺炎消毒指南》中就规定了使用紫外线消毒的方法：一般情况下紫外线消毒法采用紫外线杀菌灯作为紫外线的辐射源，要求每立方米空间定紫外线的辐照强度不得低于70μW/cm2，否则杀菌效果不佳或无效。
关于食品接触面的卫生控制（SCP）
清洁剂的有效性与下列因素有关接触时间（弱碱性清洁剂通常需要1015min，浸泡或泡沫，CIP和COP）温度（60℃-82℃）物理擦洗（刷子、抹布、压力喷枪，考虑颜色标识系统管理）水化学（与水的硬度有关）
关于食品接触面的卫生控制（SCP）
消毒剂的类型及浓度
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工的完整的产品安全计划。没有适当的GMP做基础，工厂不会成功实施HACCP。
GMP 21CFR 110介绍和应用
虫害控制（SCP）
监测目的确保害虫已经从工厂相关区域清除、并且确保随后的工作能预防害虫的出现。
监测区域厂房和地面结构布局工厂机械、设备和工器具内务管理废物处理杀虫剂的使用和其他控制措施