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腳輪NSF的審核提綱
發表時間:2012/8/9 22:02:36
腳輪NSF的審核提綱
Question 1 CFR 111.10
Procedures have been established that define work requirements for personnel to prevent microbial contamination from illness hygienic practices.
建立員工工作要求的程序以預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.
在工作前或員工被污染時需要建立包括適當的服裝，員工衛生，洗手與消毒等的衛生操作
Question 3 CFR 111.10
Procedures for removal of jewelry and other items or appropriate coverings.
不能戴首飾與其他物品或適當遮蓋物的程序
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.
在產品可能受到污染的區域，需要制定使用非滲透性的手套，發網，帽子，須套以及限制飲食，喝水，吸煙等的程序。需要建立預防所有外來物質污染的程序。
Question 5 CFR 111.10
Appropriate change rooms are available if needed and there is adequate storage of personal effects.
如果需要，應當提供適當的更衣室，更衣室能足夠儲存個人物品。
Question 6 CFR 111.12
Personnel must be qualified and have adequate training, experience and/or education necessary to perform job functions.
員工必須有資格，有足夠的培訓，經歷與教育以完成工作
Question 7 CFR 111.12
Quality responsibilities are distinct and separate from operations.
質量職責是清楚的并與生產分開的
Question 8 CFR 111.13
Procedures have been established to define the requirements for personnel who will supervise activities.
建立執行管理活動的人員明確要求的程序
Question 9 CFR 111.13
Personnel who are designated as supervisors are qualified and have written requirements.
主管人員有資格并有書面的要求
Question 10 CFR 111.14
Procedures have been established and records are maintained documenting compliance to these procedures.
應當建立程序，并且有記錄表明符合這些程序
Question 11 CFR 111.12
Job descriptions are available for all personnel and personnel have received GMP and appropriate training for their assigned functions.
所有員工以及有接受GMP與工作職責培訓員工應當有工作描述
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.
地面被適當維護；去除垃圾，廢棄物，修剪草與臨近工廠的雜草；維護道路與停車場；提供足夠的排水等
Question 13 CFR 111.15a4
Waste treatment and disposal is adequate and does not provide a source of potential contamination.
廢棄物處理應當足夠的，不能成為潛在污染的來源
Question 14 CFR 111.15a5
Production Facility is maintained in a clean and sanitary condition and in a proper state of repair.
生產工廠被維護干凈與衛生的狀況，有適當修理的狀態
Question 15 CFR 111.15
Entrances to the facilities are properly controlled and maintained to prevent contamination
確保工廠入口被適當控制與維護以預防污染
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.
制定清潔工廠時使用的清洗與消毒劑。在使用時這些藥品是安全與適當的
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.
清洗與消毒劑，殺蟲劑，殺真菌劑被識別，使用與儲存時防止對原料，加工過程與成品的摻雜；防止對加工設備，器具與包裝材料的污染
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.
建立預防昆蟲與動物進入工廠的程序，包括風幕，障礙物，鼠籠，昆蟲捕籠與滅蠅燈
Question 19 CFR111.15d3
Pest control procedures have been established for the appropriate use of any insecticides, fungicides, fumigants, rodenticides, etc.
必須建立正確使用殺蟲劑，殺真菌劑，熏劑，滅鼠劑等蟲害控制程序
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.
水的供應是安全，衛生，并在合適的溫度與壓力下。水直接接觸產品表面或作為原料必須符合美國聯邦，州與當地對飲用水的要求
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，水純度，水輸送系統不能作為膳食補充劑的潛在污染源
Question 22 CFR 111.15f
Plumbing is of adequate size and design for intended usage.
水管有足夠的尺寸，設計成規定的用途
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.
污水與廢棄物通過工廠管道正確排放，不能成為接觸面，產品，原料與供應水的潛在污染源
Question 24 CFR 111.15f4
Floor drainage is adequate (immediate and continuous drainage, no pooling, proper drain covers, etc.).
地面排水管是足夠的（立即與連續排放，沒有水池，適當的排水溝的蓋子）
Question 25 CFR 111.15f5
Backflow and cross-connection prevention is in place.
防止倒流與交叉連接
Question 26 CFR 111.15h
Bathrooms are provided and are of adequate number and location.
需要提供盥洗室，且有合適的數量與位置
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.
盥洗室與洗手設施保持干凈，不能成為組分，產品與接觸面的潛在污染源
Question 28 CFR 111.15i
Hand washing facilities are constructed and located in appropriate areas to ensure proper hand washing of personnel.
有洗手設施并位于適當的區域，以保證員工的正確洗手
Question 29 CFR 111.15j
Solid waste and trash are disposed of appropriately and not allowed to accumulate.
固體廢棄物與垃圾適當處理，不能積累
Question 30 CFR 111.15j2,3
Solid waste and trash does not provide a potential source of contamination to components, products, contact surfaces, etc.
固體垃圾與廢棄物不能成為組分，產品與接觸面的潛在污染源
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.
危險廢物需要正確控制，避免成為組分，產品與接觸面的潛在污染源
Question 32 CFR 111.15k
Sanitation supervisors have been assigned and are qualified.
衛生主管需要被指派，并有資質
Question 33 111.16
Procedures have been established for cleaning of the plant.
建立工廠的清潔程序
Question 34 CFR 111.20a
All facilities are of adequate size, construction, and design for their intended use.
所有設施有足夠的大小，結構，設計成預期的用途
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，包裝，貼標與扣留時有足夠的空間以完成操作，避免混亂，污染與交叉污染
Question 36 CFR 111.20c
There are adequate precautions against contamination by microorganisms, chemicals, filth, or other extraneous materials.
預防微生物，化學品，污物與其他外來物的污染
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，檢驗，識別，儲存與扣留使用的組分，膳食補充劑，包材與使用的標簽的區域應清楚規定與隔離
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.
在膳食補充劑制造，包裝與貼標簽使用的材料的檢疫與放行區域應被規定
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.
應規定同膳食補充劑分開的不同產品類型（如食品，化妝品，藥品）的制造，包裝，貼標簽與儲存的區域
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.
對實驗室分析，實驗室供應品與樣品的扣留，接觸面的清潔，包材與標簽，組分或膳食補充劑的儲存應分開或有明確的區域
Question 41 CFR 111.20d1i
Walls, floors, ceilings can be adequately cleaned and kept in good repair
墻面，地面與天花板應充分地清潔，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.
設備，管道等保持清潔，不能滴漏或泄露，不能成為組分，產品與接觸面的潛在污染源
Question 43 CFR 111.20d1iii
Adequate ventilation and airflow is provided in all areas of the facility.
工廠所有區域需要有足夠的通風
Question 44 CFR 111.20d1iv
Temperature and humidity control equipment is of adequate design for its intended function and is functioning properly.
溫度與濕度控制設備設計成預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.
工作區域有足夠的通道與空間，過道清楚，以利于員工完成工作以及避免污染與混亂。
Question 46 CFR 111.20e
Adequate lighting is provided in all production areas, examination areas, where equipment is cleaned and examined, etc.
在所有工作區與檢查區應有足夠的照明，照明設備被清潔與檢查。
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.).
在材料或設備暴露區域的上方的燈應有適當的結構或燈的類型以避免污染（使用安全燈，固定設施等）
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.
使用敞開容器的區域，需要有防污染的保護。如使用保護罩，特定區域，使用蓋上薄膜的設備，使用遮護等
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).
生產區域不能有蟲害，污穢等（須有足夠的遮護或其他措施）
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.
須有工廠清潔，蟲害控制與水質量(如果需要）的記錄，并符合相關的部分
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).
在水作為膳食補充劑的組分時，須有水質量的記錄并滿足要求
Question 52 CFR 111.25a,b
Procedures have been established for calibration of all instruments, controls, automated, mechanical, and electronic equipment, etc.
所有儀器；控制；自動的，機械的與電子的設備須有校正程序
Question 53 CFR 111.25c
Procedures have been established for the cleaning and sanitization of all utensils and equipment.
建立所有器具與設備的清洗與消毒程序
Question 54 CFR 111.25c
Procedures and programs have been established for maintaining equipment.
建立設備的維修程序與計劃
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.
所有設備與器具是防腐蝕的，用無毒材料制成，有合適的設計與構造，按預期用途使用
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.
設備與器具有合適的設計，不能使潤滑油，燃料，冷卻液，金屬或玻璃碎片，污穢，無關材料，污染的水或其他污染物對組分，產品與接觸面產生污染
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.
設備與器具的設計與結構能經受使用的環境，在暴露于組分，加工材料與清潔劑時不能退化
Question 58 CFR 111.27a3v
Equipment and utensils protect components and dietary supplements from contamination from any source.
設備與器具應保護組分與膳食補充劑不受任何來源的污染
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.
設備與器具應為無縫結構，如果有縫，應容易清潔，不能成為潛在污染源積累的地方
Question 60 111.27v
Equipment and utensil surfaces are inspected at routine intervals for signs of wear, damage, etc.
設備與器具表面以常規間隔進行磨損與損壞的檢查
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.
冷凍機，冰箱保存組分或膳食補充劑等設備必須有適當的功能，設計足夠
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
所有區域使用的儀器與控制設施必須正確與精確（需要時應校正），被維護，有足夠的數量。測量與測定設施包括溫度計，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).
與膳食補充劑，組分與接觸面接觸的使用的加工氣體必須控制，不能產生污染
Question 64 CFR 111.27d
All equipment, instruments, utensils, contact surfaces etc. must be maintained, cleaned and sanitized as necessary.
所有設備，器具，工具，接觸面必須被維護，清潔，必要時消毒。
Question 65 CFR 111.27d1
Equipment, utensils, etc. must be disassembled as necessary to assure maintenance, cleaning, and sanitization.
需要時設備，器具等必須能拆卸以保證維護，清洗與消毒
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.
低水分加工時設備，器具與接觸面應干燥與消毒。如果使用濕的清潔，需要干燥與消毒。
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.
濕加工：接觸面在使用前和任何中斷后應清潔與消毒。如果連續生產，在指定的間隔內應進行清潔與消毒。
Question 68 CFR 111.27d4
Surfaces that do not come into direct contact with components or dietary supplements are cleaned.
不直接接觸組分與膳食補充劑的表面需要清潔
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.
隨意使用的物品儲存在適當的容器內。在處理，使用，分發與丟掉時防止產生污染
Question 70 CFR 111.27d6
Cleaning and sanitizing agents are adequate and safe for their intended use.
清洗與消毒試劑應足夠，安全，按預期用途使用
Question 71 CFR 111.27d7
Portable equipment and utensils are properly stored after cleaning and sanitization.
輕便的設備與器具在清潔與消毒后應正確儲存
Question 72 CFR 111.30a
Automated, mechanical, or electronic equipment must be functioning properly and be adequately designed.
自動的，機械的或電子的設備應有適當的功能與充分的設計
Question 73 CFR 111.30d
Procedures are in place showing equipment is suitable for use and controls are functioning properly to maintain use.
建立表明設備適合應用，功能適當的程序
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.
建立維護，清潔與消毒所有設備，器具與接觸面的程序。保留消毒的記錄。
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).
每一臺設備應有日志，它包括使用的日期，清潔，消毒與維護的文件等（除非該文件在批記錄內）
Question 76 CFR 111.35b4
Records are available of calibrations, inspections, and checks of any automated, mechanical, or electronic equipment.
保留對自動的，機械的與電子的設備校正，檢驗，檢查的記錄
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.
按以下方式備份電子文件：當前軟件程序，過期的軟件程序用于找回過去的記錄與數據
Question 78 CFR 111.35b5ii
Backup files are an exact and complete record and are secure from alterations, erasures, or loss and damage.
備份的文件是正確與完成的記錄，不能變更，擦除，丟失與損壞。
Question 79 CFR 111.55
Production and process control systems have been implemented for each production process and/or product.
完成每一個生產過程與產品的生產與加工控制系統
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.
生產與加工被設計以保證產品的質量與質量控制小組有批準的控制系統
Question 81 CFR 111.65
Quality Control operations have been identified and implemented.
質量控制操作被識別與完成
Question 82 CFR 111.70
Specifications have been established for components, in-process materials, labels, packaging components, and finished product.
建立組分，使用的材料，標簽，包裝成分與成品的規格
Question 83 CFR 111.75
A system has been established to determine if all specifications that are established have been met.
建立是否所有規格被滿足的程序
Question 84 CFR 111.75a
Components are sampled, tested, and confirmed (released) prior to use in production.
成分在使用前應被取樣，測試與確認
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.
如果使用分析報告確認成分，供應商必須有資格，必須有這種資格維持的文件
Question 86 CFR 111.75a2iiD
Supplier Qualification Procedures are established and include initial qualification, periodic examination (requalification), and procedures for disqualification.
建立供應商資格的程序，包括初始資格，定期檢查（再給資格）與去除資格的程序
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.
建立適當的測試程序與計劃以確定加工與成品的規格是否滿足膳食補充劑要求的純度，組成，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
對接收的有包裝與標簽的產品，感官檢查需要完成，這些文件可以決定該產品是否滿足建立的規格。
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.
有包裝與標簽材料的感官檢查，最低要求再回顧供應商的發貨單以決定是否滿足規格
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.
有包裝與標簽膳食補充劑的包裝與標簽需要感官檢查，最少決定使用正確的包裝與標簽。
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.
使用科學的驗證方法，包括至少以下的一種：總的感官分析，肉眼的分析，顯微鏡分析，化學分析，或其他科學正確的方法
Question 92 CFR 111.77
Procedures and controls have been established for investigation and handling of materials that do not meet specification requirements.
建立調查與處理不滿足規格材料的程序
Question 93 CFR 111.80
Procedures have been established for the collection of representative samples.
建立收集代表性樣品的程序
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樣收集程序。
Question 95 CFR 111.87
The Quality Control Unit conducts all material reviews and makes disposition decisions.
質量控制小組指導所有材料的回顧與做決定。
Question 96 CFR 111.90
Procedures have been established for the handling of unexpected events.
建立處理意外事件的程序
Question 97 CFR 111.90a
Reprocessing controls have been established and meet all requirements and have been approved by the Quality Control Unit.
再加工應被控制，滿足要求，并被質量控制小組批準
Question 98 CFR 111.95
Records are maintained of specifications, supplier qualification and testing to ensure product meets purity, strength and composition.
保留規格，供應商資質與測試記錄以保證產品滿足純度，功能與組成
Question 99 111.103
Procedures have been established for the responsibilities of the Quality Control operations.
建立質量控制員工的職責
Question 100 111.105
Quality Control Personnel have established roles and responsibilities.
建立質量控制人員的任務與職責
Question 101 111.110
Quality Control Laboratory Operations have been established.
建立實驗室質量控制的操作
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.
質量控制操作與職責包括拒絕規格不符合組分與產品
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.
質量控制人員可以批準在加工過程或再加工處理更正偏離，意外事件或規格的不足
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.
負責進行材料回顧與處理決定的質量控制人員在執行時須有書面的記錄。
Question 105 111.120
Quality Control Operations must review and approve components, labels and packaging materials for intended use.
質量控制人員必須回顧與批準組分，標簽與包材按預期用途使用
Question 106 CFR 111.123a
Quality Control Operations and authority have been established for manufacturing records.
對加工記錄進行質量控制與批準
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.
質量控制操作決定所有加工或產品的規格被滿足；批準，放行或拒絕每一個完成的分發的批
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.
除非有書面的質量控制批準的偏離，否則不滿足規格的產品不能被批準與放行
Question 109 CFR 111.130
Quality Control Operations have been established to handle returned dietary supplements.
建立處理退貨膳食補充劑的質量控制操作
Question 110 CFR 111.140
Quality Control Operations are documented and meet all requirements.
質量控制操作被記錄并滿足所有要求
Question 111 CFR 111.140
The QC Unit performs GMP Internal Audits periodically. A documented corrective action file is maintained.
定期有質量控制小組完成GMP的內審。保留更正行動的記錄。
Question 112 CFR 111.153
Receiving, sampling, testing, release procedures have been established to fulfill this Subpart.
建立接收，取樣，測試與放行程序
Question 113 CFR 111.155
Quality Control requirements have been established for components.
建立對組分質量控制的要求
Question 114 CFR 111.160
Quality Control requirements have been established for packaging materials and labels.
建立包裝材料與標簽的質量控制要求
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.
建立接收的為膳食補充劑與散裝成品使用的包材與標簽的質量控制要求
Question 116 CFR 111.170
Rejected components, packaging, labeling, and products are appropriately quarantined and dispositioned.
拒絕的組分，包材，標簽與產品被適當檢疫與處理
Question 117 CFR 111.180
Records have been established and are being maintained to meet the requirements of Subpart G.
建立與保存記錄以滿足要求
Question 118 CFR 111.205
Master Manufacturing Records have been prepared for each unique formulation and batch size of the dietary supplement.
對膳食補充劑的每一個唯一配方與批大小提供主要加工記錄
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.
主要記錄識別加工過程的控制點，步驟與狀態以保證膳食補充劑的質量
Question 120 CFR 111.210
Master Manufacturing Records contain all of the required elements.
主要加工記錄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.
每一批加工的膳食補充劑需要保留批生產記錄
Question 122 CFR 111.255b
The Batch Record contains complete information relating to the production of each batch.
批記錄包括與每一批生產有關的完整信息
Question 123 CFR 111.255c
The Batch Record follows the master record and each step is performed appropriately.
批記錄跟隨主要的記錄，每一步被適當完成
Question 124 CFR 111.303
Procedures have been established for laboratory operations.
建立實驗室操作的程序
Question 125 CFR 111.310
Laboratory facilities used are adequate for testing of components, in-process materials, and dietary supplements.
使用足夠的測試組分，使用的材料與膳食補充劑的實驗室設施
Question 126 CFR 111.310
Laboratory controls have been established and have been approved by Quality Control.
建立實驗室的控制，并被質量控制批準
Question 127 CFR 111.315
Parameters have been set for laboratory controls for sampling plans, criteria for examination and testing methods, etc.
實驗室控制時設置采樣計劃，檢查標準與測試方法的參數
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.
明確并遵守測試每一個規格要求的方法與檢查的實驗室質量控制職責
Question 129 CFR 111.325
Quality Control Operations have maintained appropriate records as required
質量控制操作保持需要的適當的記錄
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.
表明產品的到期日或保質期，保質期必須被支持
Question 131 CFR 111.353
Procedures, including sanitation, operation and control have been established for manufacturing operations.
建立對制造過程的衛生，操作與控制的程序
Question 132 CFR 111.355
Manufacturing processes have been designed to produce a product that consistently meets specifications.
設計生產過程使生產的產品連續滿足規格
Question 133 CFR 111.360
Manufacturing Operations are conducted using adequate sanitation principles.
使用足夠的衛生原則進行加工操作
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.
在加工過程中避免微生物，污物，化學品，外來物質等的污染
Question 135 CFR 111.365h,i
Manufacturing operations have included controls in manufacturing steps to prevent contamination, including metal detection.
加工步驟中對操作進行控制以預防污染，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.
加工過程需要標識所有生產線與主要設備，包括膳食補充劑的名稱，特定的批號，所需時加工的狀態
Question 137 CFR 111.403
Procedures have been established for all packaging and labeling operations.
建立所有包裝與標簽的程序。
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.
包材與標簽分發時受控，使用后應符合。對切割與滾壓的標簽在生產或使用后用適當的電子或電子機械設備100%檢查時，標簽符合性是不必要的。
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，檢查包材與標簽符合主要加工記錄的要求
Question 140 CFR 111.410d
Records are maintained to allow a complete history and control of the packaged and labeled dietary supplement through distribution.
保持完整的記錄；控制包裝并有標簽的膳食補充劑的分發
Question 141 CFR 111.415
A Master Manufacturing Record has instructions for filling, assembling, packaging, labeling, and other related operations.
有灌裝，裝配，包裝，貼標與其它有關操作的主要加工記錄的指導
Question 142 CFR 111.415a
Procedures have been established for cleaning and sanitizing all filling and packaging equipment and utensils.
建立清潔與消毒所有灌裝與包裝設備與器具的程序
Question 143 CFR 111.415d
Physical separation is implemented to prevent mix-ups with other components and dietary supplements.
進行物理分隔以預防膳食補充劑與其他組分的混合
Question 144 CFR 111.415
Filling and packaging operations are appropriately protected from contamination sources.
灌裝與包裝操作應適當保護以避免污染源
Question 145 CFR 111.415e
Procedures have been established to identify unlabeled materials that will be held for future labeling operations.
建立標識扣留沒有標簽的材料為了以后標簽操作的程序
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.
建立分配每一批包裝的與有標簽的膳食補充劑批號的程序
Question 147 CFR 111.415g
Procedures have been established to sample a representative number of units to assure compliance with specifications.
建立取有代表性單位數量樣品的程序以保證滿足規格
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.
建立處理廢棄的或不正確的標簽或包裝以保證它們不能使用的程序
Question 149 CFR 111.420a
All repackaging or relabeling operations have first been approved by the Quality Control Unit.
所有再包裝或再貼標的操作首先應得到質量控制小組的批準
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.
檢查每一批再包裝或再貼標膳食補充劑的代表性樣品以判斷它們滿足規格。
Question 151 CFR 111.420c
Quality Control Unit has dispositioned each batch of repackaged or relabeled dietary supplement prior to release for distribution.
質量控制小組在放行每一批再包裝或再貼標膳食補充劑前應有控制與管理。
Question 152 CFR 111.425
An appropriate quarantine system has been established for holding any rejected packaged and labeled dietary supplement.
建立對扣留任何不合格有包裝與標簽的膳食補充劑的適當檢疫系統。
Question 153 CFR 111.425
Storage areas have been demonstrated to meet the necessary requirements.
表明儲存區域以滿足必要的要求
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.
在適當溫度，濕度與光照條件下儲存扣留的膳食補充劑，組分，標簽與包材，不能產生混合，污染與退化
Question 155 CFR 111.460
In-process materials requiring specific holding conditions (temperature, humidity etc.) are stored appropriately.
需要特殊保存條件（溫度，濕度等）的加工過程的材料應適當儲存
Question 156 CFR 111.470
Distribution of product must occur under conditions that will protect against contamination and deterioration.
必須在防止污染與退化的條件下分發產品
Question 157 CFR 111.475b1
Procedures have been established for the holding and distribution operations.
建立儲存與分發操作的程序
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.
保留產品分發的記錄。記錄應在最后一批膳食補充劑分發日期后再保留2年；如果有使用保質期，或在保質期后保留1年。
Question 159 CFR 111.503
Procedures have been established for the handling of returned dietary supplements.
建立處理退貨的膳食補充劑的程序
Question 160 CFR 111.510
Returned supplements have been appropriately quarantined until dispositioned by the Quality Control Unit.
質量控制小組認為需要時，退貨的補充劑應進行適當的檢疫。
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.
任何退貨的膳食補充劑必須被破壞，除非質量控制小組決定材料可被搶救或再加工
Question 162 CFR 111.520
Any salvaged material has been so designated by the Quality Control Unit.
任何搶救的材料須被質量控制小組指定。
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).
任何再加工的材料應滿足起始規格，質量控制小組對材料有適當的處理（放行或拒絕）。
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.
如果退貨的原因牽扯其他的批，必須進行這些批是否滿足規格的調查。
Question 165 CFR 111.535
Procedures have been established for salvage and reprocessing operations according to Subpart P.
建立搶救與再加工操作的程序
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.
對再加工材料，須保留質量控制小組進行的材料回顧與處理，所有測試結果與再評估的文件
Question 167 CFR 111.535b4
All Quality Control Unit evaluations and decisions have been documented.
所有質量控制小組的評估與決定應有證明文件
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.
記錄應在最后一批膳食補充劑分發日期后再保留2年；如果有使用保質期，或在保質期后保留1年。
Question 169 CFR 111.553
Procedures have been established describing how product complaints will be received, investigated, and documented.
建立產品投訴怎樣被接收，調查與記錄的程序
Question 170 CFR 111.560a[飛步腳輪www.zq242.com.cn]
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.
有資質的人員對所有產品的投訴進行回顧，以決定投訴是否為膳食補充劑不滿足其規格或質量失敗的結果
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.
調查投訴的決定與包括更正行動的調查結果應被質量控制小組批準
Question 172 CFR 111.560c
The investigation for a product complaint was appropriately extended to other batches, products, processes, etc.
產品投訴的調查適當時應延伸到其他批次，產品與加工等。
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.
保留產品投訴與調查的記錄。記錄應在最后一批膳食補充劑分發日期后再保留2年；如果有使用保質期，或在保質期后保留1年。
Question 174 CFR 111.570bii
Product complaint information has included adequate information.
產品投訴的信息應足夠
Question 175 CFR 111.605
Procedures have been established that describe the requirements for record retention under Subpart P.
建立記錄保留要求的程序
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.
記錄在保質期后保留1年，或在最后一批分發日期后再保留2年。
Question 177 CFR 111.605
All records are maintained as original record, as true copies or as electronic records.
所有記錄以原始記錄，真實件的復印件或電子數據的形式保留。
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].
建立創造，修改，維護或傳送的電子保密系統的程序并進行控制，以保證保密系統記錄的真實性，完整性與機密性
Question 179 CFR 11.10
The procedures and controls include adequate information.
程序與控制應包括足夠的信息
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.
建立使用開放電子系統的程序并控制。應識別控制的區域
Question 181 CFR 11.50
Electronic signatures conform to requirements.
電子簽名符合要求
Question 182 11.70[飛步腳輪www.zq242.com.cn
Electronic and hand-written signatures have been linked to the electronic record.
電子與手寫的簽名須同電子記錄有鏈接
Question 183 11.100- 11.200
Electronic signatures meet requirements.
電子簽名應滿足要求
Question 184 11.300
Passwords and codes have been established.
建立密碼與代碼
Question 185 腳輪NSF 8.1
Procedures have been established to define the recall of a product.
建立定義產品召回的程序
Question 186 腳輪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.
膳食補充劑制造商應向FDA提交申請，接受注冊的號碼，并按要求提供注冊的號碼
Question 187 腳輪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.飛步腳輪
建立并遵守嚴重不利事件向FDA報告的程序以符合消費者保護法案中膳食補充劑與非處方藥的要求
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