脚轮nsf的审核提纲-pg电子游戏试玩

脚轮nsf的审核提纲

发表时间:16:06:01

脚轮nsf的审核提纲
question 1 cfr 111.10
procedures have been established that define work requirements for personnel to prevent microbial contamination from illness hygienic practices.
建立员工工作要求的程序以预防疾病的微生物污染
question 2 cfr 111.10
hygienic practices have been established to include appropriate garments, personal hygiene, hand washing and sanitization, etc. prior to starting work and at any time whereby personnel can become soiled/contaminated.
在工作前或员工被污染时需要建立包括适当的服装，员工卫生，洗手与消毒等的卫生操作
question 3 cfr 111.10
procedures for removal of jewelry and other items or appropriate coverings.
不能戴首饰与其他物品或适当遮盖物的程序
question 4 cfr 111.10
procedures for use of impermeable gloves, hairnets, caps, beard covers, etc. and for restrictions on use of food, drinks, tobacco, etc. in areas whereby product contamination could occur. procedures have been established to prevent contamination from all extraneous sources.
在产品可能受到污染的区域，需要制定使用非渗透性的手套，发网，帽子，须套以及限制饮食，喝水，吸烟等的程序。需要建立预防所有外来物质污染的程序。
question 5 cfr 111.10
appropriate change rooms are available if needed and there is adequate storage of personal effects.
如果需要，应当提供适当的更衣室，更衣室能足够储存个人物品。
question 6 cfr 111.12
personnel must be qualified and have adequate training, experience and/or education necessary to perform job functions.
员工必须有资格，有足够的培训，经历与教育以完成工作
question 7 cfr 111.12
quality responsibilities are distinct and separate from operations.
质量职责是清楚的并与生产分开的
question 8 cfr 111.13
procedures have been established to define the requirements for personnel who will supervise activities.
建立执行管理活动的人员明确要求的程序
question 9 cfr 111.13
personnel who are designated as supervisors are qualified and have written requirements.
主管人员有资格并有书面的要求
question 10 cfr 111.14
procedures have been established and records are maintained documenting compliance to these procedures.
应当建立程序，并且有记录表明符合这些程序
question 11 cfr 111.12
job descriptions are available for all personnel and personnel have received gmp and appropriate training for their assigned functions.
所有员工以及有接受gmp与工作职责培训员工应当有工作描述
question 12 cfr 111.15a
grounds have been properly maintained through removal of litter and waste, cutting of grass and weeds adjacent to the plant, maintenance of roads and parking lots, providing adequate drainage, etc.
地面被适当维护；去除垃圾，废弃物，修剪草与临近工厂的杂草；维护道路与停车场；提供足够的排水等
question 13 cfr 111.15a4
waste treatment and disposal is adequate and does not provide a source of potential contamination.
废弃物处理应当足够的，不能成为潜在污染的来源
question 14 cfr 111.15a5
production facility is maintained in a clean and sanitary condition and in a proper state of repair.
生产工厂被维护干净与卫生的状况，有适当修理的状态
question 15 cfr 111.15
entrances to the facilities are properly controlled and maintained to prevent contamination
确保工厂入口被适当控制与维护以预防污染
question 16 cfr 111.15c
cleaning and sanitizing compounds have been established for cleaning the facility. these agents are safe and adequate under the conditions of use.
制定清洁工厂时使用的清洗与消毒剂。在使用时这些药品是安全与适当的
question 17 cfr 111.15c3
cleaning and sanitizing agents, pesticide chemicals, and fungicides have been identified, used, and held and stored in a manner that protects against adulteration of raw materials and in-process or finished products, and against contamination of processing equipment, utensils, and packaging materials.
清洗与消毒剂，杀虫剂，杀真菌剂被识别，使用与储存时防止对原料，加工过程与成品的掺杂；防止对加工设备，器具与包装材料的污染
question 18 cfr 111.15d1,2
procedures have been established to prevent entrance to the facility by pests and animals, including screens and barriers, rodent traps, insect traps or lights, etc.
建立预防昆虫与动物进入工厂的程序，包括风幕，障碍物，鼠笼，昆虫捕笼与灭蝇灯
question 19 cfr111.15d3
pest control procedures have been established for the appropriate use of any insecticides, fungicides, fumigants, rodenticides, etc.
必须建立正确使用杀虫剂，杀真菌剂，熏剂，灭鼠剂等虫害控制程序
question 20 cfr 111.15e
the water supply is safe and sanitary and under suitable temperature and pressure. water that may contact a product contact surface or is in fact a component must meet u.s. federal, state and local requirements for drinking water.
水的供应是安全，卫生，并在合适的温度与压力下。水直接接触产品表面或作为原料必须符合美国联邦，州与当地对饮用水的要求
question 21 cfr 111.15f3 & cfr111.15e
water sources do not act as a potential source of contamination of the dietary supplement, either due to water purity or due to the configuration and construction of the water delivery system.
水源，水纯度，水输送系统不能作为膳食补充剂的潜在污染源
question 22 cfr 111.15f
plumbing is of adequate size and design for intended usage.
水管有足够的尺寸，设计成规定的用途
question 23 cfr 111.15g
sewage and waste disposal is properly plumbed from the facility and does not provide a potential source of contamination to contact surfaces, products, components, water supplies, etc.
污水与废弃物通过工厂管道正确排放，不能成为接触面，产品，原料与供应水的潜在污染源
question 24 cfr 111.15f4
floor drainage is adequate (immediate and continuous drainage, no pooling, proper drain covers, etc.).
地面排水管是足够的（立即与连续排放，没有水池，适当的排水沟的盖子）
question 25 cfr 111.15f5
backflow and cross-connection prevention is in place.
防止倒流与交叉连接
question 26 cfr 111.15h
bathrooms are provided and are of adequate number and location.
需要提供盥洗室，且有合适的数量与位置
question 27 cfr 111.15h
bathrooms and wash facilities are kept clean and are not a potential source of contamination to components, products, contact surfaces, etc.
盥洗室与洗手设施保持干净，不能成为组分，产品与接触面的潜在污染源
question 28 cfr 111.15i
hand washing facilities are constructed and located in appropriate areas to ensure proper hand washing of personnel.
有洗手设施并位于适当的区域，以保证员工的正确洗手
question 29 cfr 111.15j
solid waste and trash are disposed of appropriately and not allowed to accumulate.
固体废弃物与垃圾适当处理，不能积累
question 30 cfr 111.15j2,3
solid waste and trash does not provide a potential source of contamination to components, products, contact surfaces, etc.
固体垃圾与废弃物不能成为组分，产品与接触面的潜在污染源
question 31 111.15 j4
hazardous waste is properly controlled so as not to provide a potential source of contamination to components, products, contact surfaces, etc.
危险废物需要正确控制，避免成为组分，产品与接触面的潜在污染源
question 32 cfr 111.15k
sanitation supervisors have been assigned and are qualified.
卫生主管需要被指派，并有资质
question 33 111.16
procedures have been established for cleaning of the plant.
建立工厂的清洁程序
question 34 cfr 111.20a
all facilities are of adequate size, construction, and design for their intended use.
所有设施有足够的大小，结构，设计成预期的用途
question 35 cfr 111.20b
there is adequate space for performing all operations and to prevent mix-ups, contaminations, and cross-contaminations during manufacturing, packaging, labeling, or holding.
在制造，包装，贴标与扣留时有足够的空间以完成操作，避免混乱，污染与交叉污染
question 36 cfr 111.20c
there are adequate precautions against contamination by microorganisms, chemicals, filth, or other extraneous materials.
预防微生物，化学品，污物与其他外来物的污染
question 37 cfr 111.20c1
areas have been clearly defined or separated for receiving, inspecting and identifying, holding and withholding from use components, dietary supplements, packaging, and labels that will be used.
接收，检验，识别，储存与扣留使用的组分，膳食补充剂，包材与使用的标签的区域应清楚规定与隔离
question 38 cfr 111.20c2
areas have been provided for quarantine and release of materials to be used in the manufacture, packaging, or labeling of dietary supplements.
在膳食补充剂制造，包装与贴标签使用的材料的检疫与放行区域应被规定
question 39 cfr 111.20c3
areas have been provided to separate the manufacturing, packaging, labeling, and holding of different product types (e.g. foods, cosmetics, pharmaceuticals) from dietary supplements.
应规定同膳食补充剂分开的不同产品类型（如食品，化妆品，药品）的制造，包装，贴标签与储存的区域
question 40 cfr 111.20c4,5,6,7
separate or defined areas exist for laboratory analysis and holding of laboratory supplies and samples, cleaning of contact surfaces, packaging and labeling, and holding of components or dietary supplements.
对实验室分析，实验室供应品与样品的扣留，接触面的清洁，包材与标签，组分或膳食补充剂的储存应分开或有明确的区域
question 41 cfr 111.20d1i
walls, floors, ceilings can be adequately cleaned and kept in good repair
墙面，地面与天花板应充分地清洁，并有良好的修理
question 42 cfr 111.20d1ii
fixtures, ducts, piping, etc. are kept clean, do not drip or leak or provide a source of condensation that could contaminate components, products, or contact surfaces.
设备，管道等保持清洁，不能滴漏或泄露，不能成为组分，产品与接触面的潜在污染源
question 43 cfr 111.20d1iii
adequate ventilation and airflow is provided in all areas of the facility.
工厂所有区域需要有足够的通风
question 44 cfr 111.20d1iv
temperature and humidity control equipment is of adequate design for its intended function and is functioning properly.
温度与湿度控制设备设计成预期的功能并能正常工作
question 45 cfr 111.20d1v
working areas have adequate access and space, aisles are clear, etc. to allow for persons to perform their duties and protect against contamination or mix-ups.
工作区域有足够的通道与空间，过道清楚，以利于员工完成工作以及避免污染与混乱。
question 46 cfr 111.20e
adequate lighting is provided in all production areas, examination areas, where equipment is cleaned and examined, etc.
在所有工作区与检查区应有足够的照明，照明设备被清洁与检查。
question 47 cfr 111.20f
for lighting that is suspended or located above areas where materials or equipment are exposed are of adequate construction or
lighting type to prevent contamination (use of safe-lights, fixtures, etc.).
在材料或设备暴露区域的上方的灯应有适当的结构或灯的类型以避免污染（使用安全灯，固定设施等）
question 48 cfr 111.20g
in areas where open vessels are used, there is adequate protection against contamination, e.g. use of protective coverings, physical
location, use of skimming equipment, use of screening, etc.
使用敞开容器的区域，需要有防污染的保护。如使用保护罩，特定区域，使用盖上薄膜的设备，使用遮护等
question 49 cfr 111.20h
production areas do not provide a haven for pests, pest infestation, filth, etc. (adequate screening and other measures are used).
生产区域不能有虫害，污秽等（须有足够的遮护或其他措施）
question 50 cfr 111.23
records have been maintained for plant cleaning, pest control, and water quality (where required) and in accordance with subpart p.
须有工厂清洁，虫害控制与水质量(如果需要）的记录，并符合相关的部分
question 51 111.23
records have been maintained to show that the quality of water, when used as a component of the dietary supplement, meets the requirements of 111.15(e)(2).
在水作为膳食补充剂的组分时，须有水质量的记录并满足要求
question 52 cfr 111.25a,b
procedures have been established for calibration of all instruments, controls, automated, mechanical, and electronic equipment, etc.
所有仪器；控制；自动的，机械的与电子的设备须有校正程序
question 53 cfr 111.25c
procedures have been established for the cleaning and sanitization of all utensils and equipment.
建立所有器具与设备的清洗与消毒程序
question 54 cfr 111.25c
procedures and programs have been established for maintaining equipment.
建立设备的维修程序与计划
question 55 cfr 111.27a
all equipment and utensils are corrosion resistant, made of nontoxic materials, and of suitable design, construction, and workmanship for their intended use.
所有设备与器具是防腐蚀的，用无毒材料制成，有合适的设计与构造，按预期用途使用
question 56 cfr 111.27a2
equipment and utensils are of appropriate design so as to not contaminate components, products, or contact surfaces with lubricants, fuel, coolants, metal or glass fragments, filth or any extraneous materials, contaminated water, or other contaminants.
设备与器具有合适的设计，不能使润滑油，燃料，冷却液，金属或玻璃碎片，污秽，无关材料，污染的水或其他污染物对组分，产品与接触面产生污染
question 57 cfr 111.27a3iv
equipment and utensils are designed and constructed to withstand the environment in which they are used and do not degrade upon exposure to components, process materials, cleaning agents, etc.
设备与器具的设计与结构能经受使用的环境，在暴露于组分，加工材料与清洁剂时不能退化
question 58 cfr 111.27a3v
equipment and utensils protect components and dietary supplements from contamination from any source.
设备与器具应保护组分与膳食补充剂不受任何来源的污染
question 59 cfr 111.27a4
equipment and utensils are constructed as seamless, or if seams exist, are easily cleanable and do not provide a place for accumulation of potential contaminants.
设备与器具应为无缝结构，如果有缝，应容易清洁，不能成为潜在污染源积累的地方
question 60 111.27v
equipment and utensil surfaces are inspected at routine intervals for signs of wear, damage, etc.
设备与器具表面以常规间隔进行磨损与损坏的检查
question 61 cfr 111.27a5
equipment such as freezers, refrigerators, etc. that are used to hold components or dietary supplements must be functioning properly and adequately designed.
冷冻机，冰箱保存组分或膳食补充剂等设备必须有适当的功能，设计足够
question 62 cfr 111.27a6
instruments and controls that are used in all areas must be accurate and precise (calibrated where necessary), maintained, and adequate in number. , measuring and metering devices such as thermometers, scales
所有区域使用的仪器与控制设施必须正确与精确（需要时应校正），被维护，有足够的数量。测量与测定设施包括温度计，天平等。
question 63 cfr 111.27a7
process gases that are used and contact dietary supplements, components, and contact surfaces must be controlled so as not to cause contamination (e.g. filters).
与膳食补充剂，组分与接触面接触的使用的加工气体必须控制，不能产生污染
question 64 cfr 111.27d
all equipment, instruments, utensils, contact surfaces etc. must be maintained, cleaned and sanitized as necessary.
所有设备，器具，工具，接触面必须被维护，清洁，必要时消毒。
question 65 cfr 111.27d1
equipment, utensils, etc. must be disassembled as necessary to assure maintenance, cleaning, and sanitization.
需要时设备，器具等必须能拆卸以保证维护，清洗与消毒
question 66 cfr 111.27d2
low moisture processing: equipment, utensils, and contact surfaces are dry and sanitized. if wet-cleaned, drying and sanitization is performed.
低水分加工时设备，器具与接触面应干燥与消毒。如果使用湿的清洁，需要干燥与消毒。
question 67 cfr 111.27d3
wet processing: contact surfaces are cleaned and sanitized before use and after any interruptions. if continuous production is performed, cleaning and sanitization is performed at designated intervals.
湿加工：接触面在使用前和任何中断后应清洁与消毒。如果连续生产，在指定的间隔内应进行清洁与消毒。
question 68 cfr 111.27d4
surfaces that do not come into direct contact with components or dietary supplements are cleaned.
不直接接触组分与膳食补充剂的表面需要清洁
question 69 cfr 111.27d5
disposable items (single-service) are stored in appropriate containers; handled, used, dispensed, and disposed of in a manner that protects against contamination.
随意使用的物品储存在适当的容器内。在处理，使用，分发与丢掉时防止产生污染
question 70 cfr 111.27d6
cleaning and sanitizing agents are adequate and safe for their intended use.
清洗与消毒试剂应足够，安全，按预期用途使用
question 71 cfr 111.27d7
portable equipment and utensils are properly stored after cleaning and sanitization.
轻便的设备与器具在清洁与消毒后应正确储存
question 72 cfr 111.30a
automated, mechanical, or electronic equipment must be functioning properly and be adequately designed.
自动的，机械的或电子的设备应有适当的功能与充分的设计
question 73 cfr 111.30d
procedures are in place showing equipment is suitable for use and controls are functioning properly to maintain use.
建立表明设备适合应用，功能适当的程序
question 74 cfr 111.35b1iii
procedures for maintenance, cleaning, and sanitization of all equipment, utensils, and contact surfaces are established and records of sanitation are maintained.
建立维护，清洁与消毒所有设备，器具与接触面的程序。保留消毒的记录。
question 75 cfr 111.35b2
equipment logbooks have been maintained for each equipment and include the date of use, and any documentation of cleaning, sanitization, maintenance, etc. (unless the documentation is in the batch record).
每一台设备应有日志，它包括使用的日期，清洁，消毒与维护的文件等（除非该文件在批记录内）
question 76 cfr 111.35b4
records are available of calibrations, inspections, and checks of any automated, mechanical, or electronic equipment.
保留对自动的，机械的与电子的设备校正，检验，检查的记录
question 77 cfr 111.35b5
backup electronic files have been maintained of the following; current software programs, outdated software programs that may be necessary to retrieve past records, and data that was entered.
按以下方式备份电子文件：当前软件程序，过期的软件程序用于找回过去的记录与数据
question 78 cfr 111.35b5ii
backup files are an exact and complete record and are secure from alterations, erasures, or loss and damage.
备份的文件是正确与完成的记录，不能变更，擦除，丢失与损坏。
question 79 cfr 111.55
production and process control systems have been implemented for each production process and/or product.
完成每一个生产过程与产品的生产与加工控制系统
question 80 cfr 111.60
production and processes have been designed to ensure the quality of the product and the quality control unit has approved the
control systems.
生产与加工被设计以保证产品的质量与质量控制小组有批准的控制系统
question 81 cfr 111.65
quality control operations have been identified and implemented.
质量控制操作被识别与完成
question 82 cfr 111.70
specifications have been established for components, in-process materials, labels, packaging components, and finished product.
建立组分，使用的材料，标签，包装成分与成品的规格
question 83 cfr 111.75
a system has been established to determine if all specifications that are established have been met.
建立是否所有规格被满足的程序
question 84 cfr 111.75a
components are sampled, tested, and confirmed (released) prior to use in production.
成分在使用前应被取样，测试与确认
question 85 cfr 111.75a2
if a certificate of analysis (coa) is used to confirm the component, the supplier must be qualified and documentation must be maintained for this qualification.
如果使用分析报告确认成分，供应商必须有资格，必须有这种资格维持的文件
question 86 cfr 111.75a2iid
supplier qualification procedures are established and include initial qualification, periodic examination (requalification), and procedures for disqualification.
建立供应商资格的程序，包括初始资格，定期检查（再给资格）与去除资格的程序
question 87 cfr 111.75b,c
proper testing procedures or programs have been established to determine if in process and finished product specifications for
purity, composition, and strength of the dietary supplement have been met.
建立适当的测试程序与计划以确定加工与成品的规格是否满足膳食补充剂要求的纯度，组成，功能
question 88 cfr 111.75e
for products that are received for packaging and labeling, visual examinations are performed and documentation is available to determine whether the product meets established specifications
对接收的有包装与标签的产品，感官检查需要完成，这些文件可以决定该产品是否满足建立的规格。
question 89 cfr 111.75f
packaging and labeling materials are visually examined, at a minimum, and are reviewed against the supplier’s invoice to determine conformance with specifications.
有包装与标签材料的感官检查，最低要求再回顾供应商的发货单以决定是否满足规格
question 90 cfr 111.75g
packaging and labeling of the finished packaged and labeled dietary supplement are visually examined, at a minimum, to determine
that the correct packaging and labeling has been used.
有包装与标签膳食补充剂的包装与标签需要感官检查，最少决定使用正确的包装与标签。
question 91cfr 111.75h
scientifically valid methods are used and include at least one of the following, a gross organoleptic analysis, macroscopic analysis,
microscopic analysis, chemical analysis, or another scientifically valid method.
使用科学的验证方法，包括至少以下的一种：总的感官分析，肉眼的分析，显微镜分析，化学分析，或其他科学正确的方法
question 92 cfr 111.77
procedures and controls have been established for investigation and handling of materials that do not meet specification requirements.
建立调查与处理不满足规格材料的程序
question 93 cfr 111.80
procedures have been established for the collection of representative samples.
建立收集代表性样品的程序
question 94 cfr 111.83
procedures have been established for the collection of reserve samples for each lot of finished material.
建立每一批成品的留样收集程序。
question 95 cfr 111.87
the quality control unit conducts all material reviews and makes disposition decisions.
质量控制小组指导所有材料的回顾与做决定。
question 96 cfr 111.90
procedures have been established for the handling of unexpected events.
建立处理意外事件的程序
question 97 cfr 111.90a
reprocessing controls have been established and meet all requirements and have been approved by the quality control unit.
再加工应被控制，满足要求，并被质量控制小组批准
question 98 cfr 111.95
records are maintained of specifications, supplier qualification and testing to ensure product meets purity, strength and composition.
保留规格，供应商资质与测试记录以保证产品满足纯度，功能与组成
question 99 111.103
procedures have been established for the responsibilities of the quality control operations.
建立质量控制员工的职责
question 100 111.105
quality control personnel have established roles and responsibilities.
建立质量控制人员的任务与职责
question 101 111.110
quality control laboratory operations have been established.
建立实验室质量控制的操作
question 102 111.113a
quality control operations and responsibilities have included the authority to reject any component or product if any specification is not met.
质量控制操作与职责包括拒绝规格不符合组分与产品
question 103 111.113b
quality control personnel may authorize a treatment, in-process treatment, or reprocessing in an attempt to correct a deviation or unexpected event, or specification deficiency.
质量控制人员可以批准在加工过程或再加工处理更正偏离，意外事件或规格的不足
question 104 111.113c
the quality control person responsible for making the material review and disposition decision has documented the review and disposition decision at the time of performance.
负责进行材料回顾与处理决定的质量控制人员在执行时须有书面的记录。
question 105 111.120
quality control operations must review and approve components, labels and packaging materials for intended use.
质量控制人员必须回顾与批准组分，标签与包材按预期用途使用
question 106 cfr 111.123a
quality control operations and authority have been established for manufacturing records.
对加工记录进行质量控制与批准
question 107 cfr 111.123a
quality control operations determine if all specifications have been met (in-process, product) and approve/release or reject has been performed on each finished batch for distribution.
质量控制操作决定所有加工或产品的规格被满足；批准，放行或拒绝每一个完成的分发的批
question 108 cfr 111.1b
quality control has not approved and released product in any form that does not meet the specifications unless quality control approved deviations have been documented.
除非有书面的质量控制批准的偏离，否则不满足规格的产品不能被批准与放行
question 109 cfr 111.130
quality control operations have been established to handle returned dietary supplements.
建立处理退货膳食补充剂的质量控制操作
question 110 cfr 111.140
quality control operations are documented and meet all requirements.
质量控制操作被记录并满足所有要求
question 111 cfr 111.140
the qc unit performs gmp internal audits periodically. a documented corrective action file is maintained.
定期有质量控制小组完成gmp的内审。保留更正行动的记录。
question 112 cfr 111.153
receiving, sampling, testing, release procedures have been established to fulfill this subpart.
建立接收，取样，测试与放行程序
question 113 cfr 111.155
quality control requirements have been established for components.
建立对组分质量控制的要求
question 114 cfr 111.160
quality control requirements have been established for packaging materials and labels.
建立包装材料与标签的质量控制要求
question 115 cfr 111.165
quality control requirements have been established for products that are received for packaging and labeling as a dietary supplement and bulk finished product.
建立接收的为膳食补充剂与散装成品使用的包材与标签的质量控制要求
question 116 cfr 111.170
rejected components, packaging, labeling, and products are appropriately quarantined and dispositioned.
拒绝的组分，包材，标签与产品被适当检疫与处理
question 117 cfr 111.180
records have been established and are being maintained to meet the requirements of subpart g.
建立与保存记录以满足要求
question 118 cfr 111.205
master manufacturing records have been prepared for each unique formulation and batch size of the dietary supplement.
对膳食补充剂的每一个唯一配方与批大小提供主要加工记录
question 119 cfr 111.205b1
the master record identifies specifications for the control points, steps, or stages in the manufacturing process where control is necessary to ensure the quality of the dietary supplement.
主要记录识别加工过程的控制点，步骤与状态以保证膳食补充剂的质量
question 120 cfr 111.210
master manufacturing records contain all of the required elements.
主要加工记录包含所有需要的要素
question 121 cfr 111.255a,d
batch production records are available per subpart p for each batch of dietary supplement that has been manufactured.
每一批加工的膳食补充剂需要保留批生产记录
question 122 cfr 111.255b
the batch record contains complete information relating to the production of each batch.
批记录包括与每一批生产有关的完整信息
question 123 cfr 111.255c
the batch record follows the master record and each step is performed appropriately.
批记录跟随主要的记录，每一步被适当完成
question 124 cfr 111.303
procedures have been established for laboratory operations.
建立实验室操作的程序
question 125 cfr 111.310
laboratory facilities used are adequate for testing of components, in-process materials, and dietary supplements.
使用足够的测试组分，使用的材料与膳食补充剂的实验室设施
question 126 cfr 111.310
laboratory controls have been established and have been approved by quality control.
建立实验室的控制，并被质量控制批准
question 127 cfr 111.315
parameters have been set for laboratory controls for sampling plans, criteria for examination and testing methods, etc.
实验室控制时设置采样计划，检查标准与测试方法的参数
question 128 cfr 111.320
quality control responsibilities for laboratory test methods and examinations used to test each specification requirement have been defined and are being followed.
明确并遵守测试每一个规格要求的方法与检查的实验室质量控制职责
question 129 cfr 111.325
quality control operations have maintained appropriate records as required
质量控制操作保持需要的适当的记录
question 130 cfr 111.70
for all products that bear expiration date or a statement of product shelf life, the shelf life must be supported.
表明产品的到期日或保质期，保质期必须被支持
question 131 cfr 111.353
procedures, including sanitation, operation and control have been established for manufacturing operations.
建立对制造过程的卫生，操作与控制的程序
question 132 cfr 111.355
manufacturing processes have been designed to produce a product that consistently meets specifications.
设计生产过程使生产的产品连续满足规格
question 133 cfr 111.360
manufacturing operations are conducted using adequate sanitation principles.
使用足够的卫生原则进行加工操作
question 134 cfr 111.365a-g
precautions have been taken to prevent contamination, such as micro, filth, chemical, foreign material, etc., throughout the manufacturing process.
在加工过程中避免微生物，污物，化学品，外来物质等的污染
question 135 cfr 111.365h,i
manufacturing operations have included controls in manufacturing steps to prevent contamination, including metal detection.
加工步骤中对操作进行控制以预防污染，包括使用金探
question 136 cfr 111.365j,k
manufacturing operations have included the identification of all process lines and major equipment used during manufacturing to
indicate their contents, including the name of the dietary supplement and the specific batch or lot number, and when necessary, the phase of manufacturing.
加工过程需要标识所有生产线与主要设备，包括膳食补充剂的名称，特定的批号，所需时加工的状态
question 137 cfr 111.403
procedures have been established for all packaging and labeling operations.
建立所有包装与标签的程序。
question 138 cfr 111.410b
packaging and labels are controlled for issuance and are reconciled after use.
note: reconciliation is not necessary for cut or rolled labels when 100% examination is performed by appropriate electronic or electromechanical equipment during or after completion of operations.
包材与标签分发时受控，使用后应符合。对切割与滚压的标签在生产或使用后用适当的电子或电子机械设备100%检查时，标签符合性是不必要的。
question 139 cfr 111.410c
packaging and labeling materials are examined before usage to determine that they conform to the master manufacturing record.
使用前，检查包材与标签符合主要加工记录的要求
question 140 cfr 111.410d
records are maintained to allow a complete history and control of the packaged and labeled dietary supplement through distribution.
保持完整的记录；控制包装并有标签的膳食补充剂的分发
question 141 cfr 111.415
a master manufacturing record has instructions for filling, assembling, packaging, labeling, and other related operations.
有灌装，装配，包装，贴标与其它有关操作的主要加工记录的指导
question 142 cfr 111.415a
procedures have been established for cleaning and sanitizing all filling and packaging equipment and utensils.
建立清洁与消毒所有灌装与包装设备与器具的程序
question 143 cfr 111.415d
physical separation is implemented to prevent mix-ups with other components and dietary supplements.
进行物理分隔以预防膳食补充剂与其他组分的混合
question 144 cfr 111.415
filling and packaging operations are appropriately protected from contamination sources.
灌装与包装操作应适当保护以避免污染源
question 145 cfr 111.415e
procedures have been established to identify unlabeled materials that will be held for future labeling operations.
建立标识扣留没有标签的材料为了以后标签操作的程序
question 146 cfr 111.415f
procedures have been established for assigning a lot or batch number for each lot of packaged and labeled dietary supplement.
建立分配每一批包装的与有标签的膳食补充剂批号的程序
question 147 cfr 111.415g
procedures have been established to sample a representative number of units to assure compliance with specifications.
建立取有代表性单位数量样品的程序以保证满足规格
question 148 cfr 111.415h
disposal procedures have been established for disposing of labels or packaging materials that are obsolete or incorrect to ensure that they are not used.
建立处理废弃的或不正确的标签或包装以保证它们不能使用的程序
question 149 cfr 111.420a
all repackaging or relabeling operations have first been approved by the quality control unit.
所有再包装或再贴标的操作首先应得到质量控制小组的批准
question 150 cfr 111.420b
representative samples of each batch of repackaged or relabeled dietary supplement have been examined to determine if they conform to specifications.
检查每一批再包装或再贴标膳食补充剂的代表性样品以判断它们满足规格。
question 151 cfr 111.420c
quality control unit has dispositioned each batch of repackaged or relabeled dietary supplement prior to release for distribution.
质量控制小组在放行每一批再包装或再贴标膳食补充剂前应有控制与管理。
question 152 cfr 111.425
an appropriate quarantine system has been established for holding any rejected packaged and labeled dietary supplement.
建立对扣留任何不合格有包装与标签的膳食补充剂的适当检疫系统。
question 153 cfr 111.425
storage areas have been demonstrated to meet the necessary requirements.
表明储存区域以满足必要的要求
question 154 cfr 111.455
dietary supplements, components, labeling, and packaging are held under the appropriate conditions of temperature, humidity, and light and do not lead to mix-up, contamination, or deterioration.
在适当温度，湿度与光照条件下储存扣留的膳食补充剂，组分，标签与包材，不能产生混合，污染与退化
question 155 cfr 111.460
in-process materials requiring specific holding conditions (temperature, humidity etc.) are stored appropriately.
需要特殊保存条件（温度，湿度等）的加工过程的材料应适当储存
question 156 cfr 111.470
distribution of product must occur under conditions that will protect against contamination and deterioration.
必须在防止污染与退化的条件下分发产品
question 157 cfr 111.475b1
procedures have been established for the holding and distribution operations.
建立储存与分发操作的程序
question 158 cfr 111.475b2
product distribution records have been retained. records shall be maintained for a period of 2 years beyond the date of distribution of the last batch of dietary supplements associated with those records or 1 year past the shelf life date, if shelf life dating is used.
保留产品分发的记录。记录应在最后一批膳食补充剂分发日期后再保留2年；如果有使用保质期，或在保质期后保留1年。
question 159 cfr 111.503
procedures have been established for the handling of returned dietary supplements.
建立处理退货的膳食补充剂的程序
question 160 cfr 111.510
returned supplements have been appropriately quarantined until dispositioned by the quality control unit.
质量控制小组认为需要时，退货的补充剂应进行适当的检疫。
question 161 cfr 111.515
any returned dietary supplement must be either destroyed or disposed of unless the quality control unit has determined that the material can be salvaged or reprocessed.
任何退货的膳食补充剂必须被破坏，除非质量控制小组决定材料可被抢救或再加工
question 162 cfr 111.520
any salvaged material has been so designated by the quality control unit.
任何抢救的材料须被质量控制小组指定。
question 163 cfr 111.525
any reprocessed material has met its original specification and the quality control unit has appropriately dispositioned the material (release or reject).
任何再加工的材料应满足起始规格，质量控制小组对材料有适当的处理（放行或拒绝）。
question 164 cfr 111.530
if the reason for a return implicates other batches, an investigation has been performed to determine if those batches comply with specifications.
如果退货的原因牵扯其他的批，必须进行这些批是否满足规格的调查。
question 165 cfr 111.535
procedures have been established for salvage and reprocessing operations according to subpart p.
建立抢救与再加工操作的程序
question 166 cfr 111.535b
documentation has been maintained for material reviews and dispositions, all testing results, any reevaluations by the quality control unit for reprocessed materials.
对再加工材料，须保留质量控制小组进行的材料回顾与处理，所有测试结果与再评估的文件
question 167 cfr 111.535b4
all quality control unit evaluations and decisions have been documented.
所有质量控制小组的评估与决定应有证明文件
question 168 cfr 111.535
records shall be maintained for a period of 2 years beyond the date of distribution of the last batch of dietary supplements associated with those records or 1 year past the shelf life date, if shelf life dating is used.
记录应在最后一批膳食补充剂分发日期后再保留2年；如果有使用保质期，或在保质期后保留1年。
question 169 cfr 111.553
procedures have been established describing how product complaints will be received, investigated, and documented.
建立产品投诉怎样被接收，调查与记录的程序
question 170 cfr 111.560a[飞步脚轮pg电子游戏试玩-pg电子直营站]
all product complaints have been reviewed by a qualified person to determine if the complaint was the result of a failure of the dietary supplement to meet any of its specifications or quality.
有资质的人员对所有产品的投诉进行回顾，以决定投诉是否为膳食补充剂不满足其规格或质量失败的结果
question 171 cfr 111.560b
the decision to investigate a complaint as well as the final decision as a result of the investigation, including corrective action, has been approved by the quality control unit.
调查投诉的决定与包括更正行动的调查结果应被质量控制小组批准
question 172 cfr 111.560c
the investigation for a product complaint was appropriately extended to other batches, products, processes, etc.
产品投诉的调查适当时应延伸到其他批次，产品与加工等。
question 173 cfr 111.570a
records for each product complaint and investigation have been maintained. records shall be maintained for a period of 2 years beyond the date of distribution of the last batch of dietary supplements associated with those records or 1 year past the shelf life date, if shelf life dating is used.
保留产品投诉与调查的记录。记录应在最后一批膳食补充剂分发日期后再保留2年；如果有使用保质期，或在保质期后保留1年。
question 174 cfr 111.570bii
product complaint information has included adequate information.
产品投诉的信息应足够
question 175 cfr 111.605
procedures have been established that describe the requirements for record retention under subpart p.
建立记录保留要求的程序
question 176 cfr 111.605
records will be maintained for 1 year after the shelf life date or 2 years beyond the date of distribution of the last batch associated with those records.
记录在保质期后保留1年，或在最后一批分发日期后再保留2年。
question 177 cfr 111.605
all records are maintained as original record, as true copies or as electronic records.
所有记录以原始记录，真实件的复印件或电子数据的形式保留。
question 178 cfr 11.10
procedures and controls have been established for electronic closed systems used to create, modify, maintain, or transmit electronic records in order to ensure the authenticity, integrity, and confidentiality of the records [closed systems].
建立创造，修改，维护或传送的电子保密系统的程序并进行控制，以保证保密系统记录的真实性，完整性与机密性
question 179 cfr 11.10
the procedures and controls include adequate information.
程序与控制应包括足够的信息
question 180 cfr 11.30
procedures and controls have been established for use of open electronic systems. areas of control have been identified, as necessary, per the requirements in 11.10.
建立使用开放电子系统的程序并控制。应识别控制的区域
question 181 cfr 11.50
electronic signatures conform to requirements.
电子签名符合要求
question 182 11.70[飞步脚轮pg电子游戏试玩-pg电子直营站
electronic and hand-written signatures have been linked to the electronic record.
电子与手写的签名须同电子记录有链接
question 183 11.100- 11.200
electronic signatures meet requirements.
电子签名应满足要求
question 184 11.300
passwords and codes have been established.
建立密码与代码
question 185 脚轮nsf 8.1
procedures have been established to define the recall of a product.
建立定义产品召回的程序
question 186 脚轮nsf 8.2
manufacturers of dietary supplements shall submit application to usfda for registration, receive a registration number, and provide the registration number upon request.
膳食补充剂制造商应向fda提交申请，接受注册的号码，并按要求提供注册的号码
question 187 脚轮nsf 8.3
procedures shall be established and followed for reporting serious adverse events to the usfda in accordance with the dietary supplement and non-prescription drug consumer protection act.飞步脚轮
建立并遵守严重不利事件向fda报告的程序以符合消费者保护法案中膳食补充剂与非处方药的要求