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Table of Contents
目录
?
SUBPART B 111.10 –
111.14: Personnel
人员
? SUBPART C
111.15 –
111.23: Physical Plant and
Grounds
工厂与场所
?
SUBPART D 111.25 –
111.35: Equipment
and Utensils
设备与器具
? SUBPART E 111.55
-111.95:
Production and Process Control System
生产与过程控制系统
?
SUBPART F 111
.103-111.140: Production
and Process Control System:
?
Requirements for Quality Control
生产与过程控制系统对质量控制的要求
? SUBPART G 111.153 –
111.180: Production and Process Control System:
? Requirements for components,
packaging, and labels
生产与过程控制系统对成分，包装与标签的要求
? S
UBPART H 111.205-111.210:
Production and Process Control System:
? Requirements for the Master
Manufacturing Record.
生产与过程控制系统对主要制造记录的要求
? SUBPART I 111.255 –
111.260: Production and Process Control System:
? Requirements for the Batch Production
Record
.
生产与过程控制系统对批生产记录的要求
? SUBPART J 111.303 –
111.325: Production and Process Control System:
? Requirements for Laboratory
Operations
生产与过程控制系统对实验室操作的要求
? SUBPART K 111.353 –
111.365: Production and Process Control System
? Requirements for
Manufacturing
Operations
生产与过程控制系统对制造过程的要求
? SUBPART L 111.403 –
111.425: Production and process control system
? Requirements for Packaging and Labels
Operation
生产与过程控制系统对包装与标签操作的要求
? SUBPART M 111.453 –
111.475: Holding and Distributing
扣留与分发
? SUBPART N
111.503
–
111.535: Return of Dietary Supplements
膳食补充剂的退货
?
SUBPART O 111.553 –
111.570: Product
Complaints
产品投诉
? SUBPART P 111.605 –
111.610: Records and Recordkeeping
记录与记录保留
? 11.10
–
11.50: Electronic Records
电子记录
? NSF/ANSI
173 Section 8.2:
?
Compliance
with the Public Health
Security and Bioterrorism
符合公共健康安全与生物反恐
?
NSF/ANSI 173 Section 8.3: Adverse Event Reporting
不利事件的报告
?
NSF/ANSI 173 Section 8.4: Recall Procedures
回收程序
? Appendix 1
NSF 229 –
Functional Food Guideline
功能性食品导则
?
Appendix 2 NSF 306 –
GMP for Sport
运动食品的
GMP
要求
? Appendix 3 NSF 306 –
GMP
for Sport & NSF 229
–
Functional Food Guideline
?
运动食品与功能性食品的
GMP
要求
? PERSONNEL
?
B
人员
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
? a. A written procedure shall exist
and be current stating that personnel with medical
conditions such as
open lesions or
infected
?
规定员工身体状况如开放性伤害或感染
的书面程序必须存在并且为当前的
? wounds
wil
l be removed from the manufacturing
process so as to prevent product adulteration
during
manufacturing or storage.
?
在制造或存储时有伤口的员工远离制造流程，以避免产品被掺杂
? The procedure shall state that such
health conditions will be reported to
supervision.
?
必须建立上述身体情况向主管汇报的程序，以便于监管
? b. Inspection verifies that such
workers are not in areas where adulteration could
occur.
?
有检查的验证表明上述的员工不在掺杂可能发生的区域
? c. Personnel shall be trained on the
written procedure and knowledgeable of the disease
control policies
?
员工必须进行疾病控制方针的书面程序与知识的培训
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
?
a.
A
written
dress
code
shall
exist
and
be
current
stating
appropriate
attire
for
workers,
supervisors,
managers and visitors to all parts of
the production, storage, packaging and testing
facilities.
?
表明员工，主管，经理，参观者进
入生产，储存，包装与测试区域穿着适当服装的书面服装规则必
须存在且为当前的
?
b.
Outer
garments
shall
be
donned
prior
to
entering
the
facility
and
shall
not
be
worn
outside
the
production facility or home. Therefore
proper changing areas are required. Outer garments
shall have long
sleeves and have
secured fasteners. Above waist pockets (or
carrying items in pockets) should be avoided.
?
进入工厂前必须穿工作衣，并且不能在生产工厂外面或家里穿工作衣。
也需要有适当的更衣区域，
工作衣需要有长袖子与安全的纽扣。避免有在腰部以上的口袋
或口袋内存放的物品。
?
c.
Outer garments shall not be worn into restroom and
appropriate hooks should be provided.
?
不能在厕所内穿工作衣，需要有适当的挂钩。
?
d.
A
written
procedure
shall
exist
and
be
current
describing
hand
washing
requirements
including
methods and
frequencies. The procedure shall also cover glove
use and hand sanitizers if used.
?
包括洗手方法与频率的洗手程序必须存在且为当前的，如果需要该程序应包含戴手套与使用消毒
液。
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
? A written procedure shall exist and
be current describing wearing of jewelry. Jewelry
if allowed must be
secured to prevent
product adulteration. Hand jewelry must be covered
if it cannot be removed.
?
戴首饰的书面程序必须存在且为当前的。如果允许戴首饰，则必须保证是安全的以预防产
品掺
杂。手上的饰
品如果不能去除，则必须覆盖保护。
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。
? a. A written procedure
shall exist and be current excluding the use of
tobacco products, on sumption of
food,
gum, drink or medicine from production areas.
?
在生产区域不能使用香烟，饮食，口香糖，饮料与药品
的书面程序必须存在并且为当前的
? b. A
written procedure shall exist and be
cu
rrent describing what types of items
cannot be taken into
production
areas
including
personal
effects
or
clothing.
The
procedure
should
cover
the
prevention
of
personal care products from entering
product.
?
包括描述个人财物与衣服等条款类型不能带入生产区域的书面程序必须存在并且为当前的。该程<
/p>
序包含预防
个人喜欢的产品混入产品。
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。
? a. Change rooms
if needed are orderly and clean. Procedures cover
cleaning change roo
ms.
?
所需的更衣室应当整洁与干净，有清洁更衣室的程序。
? b. Training has occurred for all the
above policies
?
对以上所有方针进行培训
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
?
All personnel shall have
written job descriptions, which include job
requirements and reporting structure.
Job
descriptions
should
follow
good
documentation
practices
including
revision
control
and
appropriate
sign offs.
?
所有员工必
须有包括工作要求与汇告结构的书面的工作描述。工作描述应当遵守包括修改与结束的
良
好文件规范。
?
b. All
personnel including management shall receive
annual GMP training and education to perform their
assigned functions.
?
包括管理者的所有员工每年接受
G
MP
的培训与教育以完成指定的工作
?
c. Training comprehension
for annual GMP training is required. Comprehension
can be shown by routine
questioning of
employees to determine understanding of GMPs as
they relate to their job function.
?
需要有年度
GMP
培训的理解。培训的理解可
以以员工日常询问的方式进行以确定员工明白了与他
们工作职责有关的
< br>GMP
要求。
?
d. Temporary workers shall receive
documented basic GMP training prior to beginning
work.
?
临时工在上岗前必须有书面的基本
GMP
的培训
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
?
a. A clear organization chart shall be available
that is current and up to date.
?
有最近的明确的组织结构图
? b. Quality control
department/personnel shall exist and duties shall
be documented (specific duties listed
in Subpart F). The
?
Quality Manager shall not report directly to the
Production Manager to ensure that quality
decisions can
be
made
independent
of
production
decisions.
Consideration
will
be
given
for
small
plants
where
individuals have
multiple organizational responsibilities
?
质量控制部门与人员必须存在，其职责必须书面化（特
定的职责在
F
部分）
。质量经理不能直
接向
生产经理
汇报，以保证质量的决
定与生产的决定是独立的。个人有多个组织职责的小工厂可以体
谅。
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
?
a. Supervisors shall have
written job descriptions, which include job
requirements and reporting structure.
Job descriptio
ns should?
f
ollow
good
documentation
practices
including
revision
control
and
appropriate
sign offs.
?
主管有包括
工作要求与汇告结构的书面的工作描述，工作描述应当遵守包括修改与结束的良好文件
规
范。
?
b. Assure
each department has designated and qualified
supervisors.
?
确保每个部门有指定的并有资质的主管
?
c.
Procedures
for
supervisors,
managers,
and
other
levels
of
supervision
and
responsibility
exist.
The
procedures should
outline?the requirements to be in a supervisory
position and also periodic assessment
and procedures to remove a person from
supervisory responsibilities if they do not
sustain the qualification
?
主
管，经理与管理的其他等级的程序与职责应当存在。该程序应当列出管理职位的要求，并定期评
< br>估；如果不能胜任，应当调离管理职位。
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
? a. If multiple sh
ifts of
operation are used, designated trained supervisors
are required
?
如果有多个班次的生产，需要有指定的培训的主管。
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
?
a
.
A
written
procedure
shall
exist
and
be
current
outlining
the
training
policy
and
program.
The
procedure shall include how
? training is conducted for new
hires, annual training for all personnel and
contractor training if applicable.
The
training
program
should
include
training
topics
and
frequencies
as
well
as
forms
for
documenting
training.
?
培训方针与计划的书面程序必须存在且为当前的。该
程序必须包含新员工怎样培训，所有员工或
适用的承包者的年
度培训。培训计划应当包含培训主题与频率，有培训的记录。
? b. Training and procedures shall
be available in appropriate languages.
?
用适当的语言进行培训与书写程序。
? c. Training documentation shall
include a roster of who attended, date of
training, subject matter taught
and the
name of the trainer.
?
培训记录应当包含培训人的名单，培训日期，培训主题与培训老师。
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
?
a.
All
personnel
shall
have
written
job
descriptions,
which
include
job
requirements
and
reporting
structure Job
descriptions
?
should follow
good documentation practices including revision
control and appropriate sign offs.
?
所有员工必须有包括工作要求与汇告结构的书面的工作描述。工作描述应当遵守包括修改与结束
的
良好文件规范。
?
b. All personnel including management
shall receive annual GMP training and education to
perform their
assigned functions.
?
包括管理者的所有员工每年接受
G
MP
的培训与教育以完成指定的工作
?
c. Training comprehension
for annual GMP training is required. Comprehension
can be shown by routine
questioning of?
employees to determine understanding
of GMPs as they relate to their job function.
?
需要有年度
GMP
培
训的理解。培训的理解可以以员工日常询问的方式进行以确定员工明白了与他
们工作职责
有关的
GMP
要求。
?
d. Temporary workers shall
receive documented basic GMP training prior to
beginning work.
?
临时工在上岗前必须有
书面的基本
GMP
的培训
? PHYSICAL PLANT AND
GROUNDS
?
工厂与场所
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
< br>
? No areas of clutter shall
exist around the plant’s perimeter that could be
pest harborage areas.
?
工厂周边没有混乱的区域导致害虫藏匿
?
b.
Vegetation
around
the
outside
perimeter
of
the
facility
shall
be
kept
to
a
minimum.
Individual
situations shall
be evaluated
? based on pest
co
ntrol system.
?
工厂外围的草木保持最少，个别状况应根据虫害控制体系的评估
? c. Roads, docks, parking lots and
yards shall be clean, in good repair and minimize
dust.
?
道路，码头，
停车场与院子保持干净，有良好维护，有最少的灰尘
?
d. Standing water shall not be evident around
plant’s perimeter.
?
工厂周边不能有明显的积水
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
? a. Outside waste containers shall be
covered and emptied to prevent overflowing.
Inorganic conta
iners
are not
required to be covered.
?
外
面的垃圾容器被覆盖与清空以预防溢出。存储无机物的容器不必被覆盖。
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
? a. Maintenance program
exi
sts for the facility.
?
有工厂的维修计划
? b.
Cleaning procedures cover all areas of the
facilities and grounds.
?
清洁程序包含工厂与场所的所有区域
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
? All doors to the outside shall fit
tightly (i.e. no visible light around or under
doorway) and remain closed
when not in
use.
?
所有通向外面的门被坚固地安装如门口周围或
地下没有可见光，不使用时保持关闭。
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
? A written procedure shall
exist and be current concerning chemical control.
The procedure should outline
the
purchasing policy for chemicals, list approved
chemicals, give quality controls on purchasing to
ensure
that
only
approved
chemicals
are
purchased
and
describe
chemical
usage
guidelines
(including
concentrations
and areas where chemicals can be used).
?
化学
品控制的书面程序必须存在且为当前的。程序应当列出化学品采购的方针，批准的化学品清
单，进行质
量控制以确保采购批准的化学品，描述化学品使
用的指南（包含浓度与使用的区域）
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
? All chemicals shall be stored in
labeled contain
ers and used for their
intended purpose only.
?
所有化学品被储存在有标签的容器内，并按规定用途使用
? b. All chemicals shall be stored
away from product and equipment to prevent
contamination through
spills. All
spills should be cleaned up immediately.
?
所有化学品远离产品与设备储存以防止溢出的污染。所
有污染应当被立即清理。
? c. All
chemicals shall be stored with like substances.
Food grade chemicals shall not be stored with
non
-
food grade chemicals.
?
所有化学品与相似品一起储存。食品级化学品不能同非
食品级化学品储存在一起。
Question 18 CFR 111.15d1,2
Procedures have been established to
prevent entrance to the facility by pests and
animals, including screens
and
barriers, rodenttraps, 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
?
a. Exterior
openings (windows, ventilation etc.) are screened
or sealed to protect against pests.
?
外部的开口（窗，通风设施）应被遮蔽或密封以避免害虫进入
?
b. It is required that a
licensed pest control agent provides pest control.
If internal personnel are used,
then
the same level of expertise shall be provided. The
up to date license, contract and insurance shall
be
on file.
?
要求有资
质的虫害控制公司进行虫害控制。如果内部人员进行虫害控制，应当具有同样的技术水
平
。更新的资质证书，合同与保险应当存档。
?
c.
The
licensed
agent
is
expected
to
provide
aggressive
support
to
plant
pest
control,
housekeeping,
sanitation and maintenance programs as
they relate to potential pest harborages or
conditions susceptible
to
pest
infestations.
Any
conditions
noted
by
the
pest
agent,
shall
have
documented
corrective
action
implementation. Company personnel shall
review all reports.
?
最好有资质的虫
害控制公司对工厂的虫害控制，总务，卫生与维修项目等与潜在虫害藏身或虫害容
易出没
的区域提供支持。虫害控制公司的要求，工厂应完成书面的更正行动。公司人员必须回顾所
有的报告。
?
d.
The
pest
control
agency
should
provide
a
report
outlining
the
methods
used
in
developing
the
placement of traps and the logic used
in creating the pest control program.
?
虫害控制公司应当提供陷阱设置发展的方法与创造虫害控制计划的逻辑。
?
e.
The
pest
control
system
shall
include
at
a
minimum
bait
traps
(only
located
outside
of
buildings),
interior pest traps (glue boards or
other non-chemical means) and insect lights. Other
methods can be used.
A map of all units
(lights and traps) shall be kept up to date.
?
虫害控制系统应当提供包含最少的诱饵
(
只在建筑物外围使用
),
内部的陷阱（粘胶板
或非化学的方
法）与灭蝇灯。别的方法也可使用。包含灭蝇灯与陷阱的图必须保留并及时
更新。
?
f. Exterior
doorways shall have traps on either side of the
door opening inside the building.
?
外部门口在向建筑物内部的门两侧也应放陷阱。
?
g. All traps shall be
marked or fixed to a location to prevent movement.
?
所有陷阱应当被标记或固定在一个位置以避免移动。
?
h. Pest traps and
lights shall be monitored for activity. The
activity shall be reported in a written document
including
where
the
activity
occurred,
what
type
of
activity
occurred
and
any
corrective
actions
taken.
If
activity warrants, frequency may be
increased. Traps shall be checked at least
monthly. High activity may
warrant more
frequent checks.
?
陷阱与灭蝇灯的活动应
当被监控。监控的记录包括活动发生的地点，类型与相应的更正行动。如果
活动被保证，
可以增加频率。
至少每月检查陷阱，更多的检查频率可以保证更高的活动。
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，灭鼠剂的程序
? a. Use of chemical sprays is not
typical inside production facilities. If chemical
means are needed
because
of
pest infestations, then procedures shall exist
outlining that all production shall cease and all
product be
stored in a means to prevent
adulteration. Production records shall reflect
adherence to this policy during
chemical applications. Logs
of applied chemicals shall be kept.
MSDS’s for all applied chemicals shall be
kept.
?
使用化学喷雾不是生产工厂内部的典型方法。如果因为虫害出
没使用化学方法，所有生产停止与
所有产品被
存放以避免掺杂的程序必须建立。在化学品使用时，生产记录能反应化学品使用的这一
< br>方针。必须保留所有使用化学品的
MSDS
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，州与当地对饮用的要求
?
a. Water supply shall be
safe and of adequate temperature and pressure at
all points of use in the facility
which
can be determined by checking for flow at various
faucets or other points of use
?
通过检查各个水龙头或使用的其他
点来确定工厂内在各个点使用的水是安全的，并有合适的温度与
压力
?
b. If the plant has
more than one water system (potable, non-potable,
treated, DI etc.) then piping shall be
labeled. Facility
?
Plumbing and Water Line Diagrams should
be available.
?
如果工厂有多个水系统（饮用
水，非饮用水，处理水等）
，管道必须标示。工厂水管与水的线路图
需要标示。
?
c.
Water used as a component (i.e. as an ingredient
or that contacts product contact surfaces), must
meet
Federal, State and local
requirements (at a minimum EPA NPDW 40 CFR Part
141) at point of use. Non-U.S.
firms
must meet equivalent standards.
?
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（最低美国环保署
NPDW 40 CFR Part
141
的要求）非美国公司必须满足相等的标准）
?
d. A written water-testing
program shall exist and be current for water used
as a component. The program
shall
outline testing frequency, sample locations and
testing requirements. Sampling shall occur at
point of
use and vary from time to time
if multiple points of use exist. Testing at a
minimum should include weekly
micro
testing (total plate count, yeast & molds) or
m
inimum
chlorine
level
as outlined
in 40
CFR
part
141.
Additional testing may
be needed to ensure water standards are met.
?
水作为原料的测试书面计划必须存在并为当前的。该计划必须列明测试频
率，取样地点与测试要
求。在使用的点取样，如果使用多个点，则有时变化取样点。测试
最低包括每周微生物（菌落总
数，酵母与霉菌）
，或氯含量测试
。附加测试也需要以保证满足
标准
?
e. If in house
manufactured ice is used for product contact, then
the ice shall be tested for microbiological
potability
semi-annually.
Purchased
ice
shall
have
a
certificate
of
potability.
Maintenance
of
ice
machine
shall have written procedures.
< br>?
如果自己制作的冰用于产品的接触，则每半年测试微生物。购买的冰需要食用冰
的证书。制冰机的
维护需要有书面的程序
?
f. If steam is product
contact, then boiler treatment chemicals shall be
food grade.
?
如果蒸汽接触产品，则锅炉处理的化学品必须为食用级
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
? a. Water piping shall be so
configured that it does not become a source of
contamination (elimination of
dead end
piping and proper drainage).
?
水管道的配置不能作为污染源（排除死的末端管道，正确的排水）
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
? Piping and plumbing throughout the
facility shall not be leaking or
damaged.
?
贯穿工厂的水管不能泄露或损坏
?
b. All plumbing should be appropriately trapped to
prevent back flow.
?
所有水管适当的设计以预防回流
?
c. Drip legs should be piped into floor drains
(allowing for siphon breaks). Drip legs shall not
drip onto the
floor.
?
滴水管通过管道进入地面下水道（允许虹吸管的折断）
；滴水管不能直接滴到地面上
?
d. Standing water shall not be evident within the
manufacturing faci
lity.
?
制造工厂不能有明显的积水
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
? a.
Sewage shall be disposed into a properly
maintained and approved sewage system that
complies with
local regulatory
requirements. Process and sanitary sewers shall be
plumbed separately.
?
污水排放在正确维护与批准的排污系统，并且满足当地法规的
要求。加工污水与生活污水分开排
放
? b. Sewage lines shall not vent
inside of buildings
?
污水管不能在建筑物内部排放
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）
? All areas
requir
ing wet cleaning should have
adequate floor drains.
?
需要湿清洁的区域应有足够的地面排水管
? b. All drains shall be covered with
grating and be free of debris.
?
所有排水沟有栅栏覆盖并没有碎片
?
c. Drains shall be part of cleaning procedures and
be odor free.
?
清洁程序应包括排水沟，排水沟没有异味
? d. Drains shall drain properly and
not back up or contain standing water.
?
排水沟正确排放，不能倒流，不能含有积水
Question 25 CFR 111.15f5
Backflow and cross-connection
prevention is in place.
防止倒流与交叉连接
?
a.
The
city
water
or
water
supply
to
the
plant
shall
have
a
backflow
prevention
device
at
the
plant’s
connection point. An annual PM is
required for checking the backflow system.
?
市政水或水源到工厂连接点处有防止倒流设施。对防倒
流系统的年度维护是需要的
? b. All hose
drops or points of use where product siphoning
could occur shall have backflow
prevention.
An annual PM is required
for checking backflow devices.
?
在产品可能发生虹吸的水管或使用
的点需要有防止倒流的设施。对防倒流装置的年度维护是需要
的。
Question 26 CFR 111.15h
Bathrooms are provided and are of
adequate number and location.
需要提供厕所，且有合适的数量与位置
? Bathroom shall be
availabl
e to all workers, well lit,
functional and stocked.
?
必须有提供给工作者使用的厕所，有好的照明，良好的功能与结构
? b. Bathrooms shall be
clean and sanitary at all times. Routine
documented cleaning must take place.
?
厕所一直清洁与卫生，有常规的检查记录。
? c. Bathrooms must have signs
directin
g employees to wash hands
before returning to work
?
返回工作时在厕所内有指示员工洗手的标示
? d. Bathroom doors shall be
self
-closing and not open into
operation areas where product is exposed.
?
厕所的门为自闭门；在产品暴露区域，厕所的门不能
直接通向生产区
? e. Bathrooms
shall vent mechanical
ly to the outside
?
厕所有通向外面的机械通风装置
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.
厕所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
? a. Routine
docum
ented cleaning of bathrooms and
hand wash facilities must take place
?
有常规的厕所与洗手设施的检查记录
? b. Hand washing facilities cannot be
used to clean utensils or equipment.
?
洗手设施不能用于洗器具或设备
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
? a. Hand washing facilities
furnished with tempered water shall be located
where employees are required
to wash
hands.
?
员工需要洗手的区域有带温水的洗手设施
?
b.
Hand
w
ashing
facilities
shall
have
hands
free
faucets.
Hands
free
can
be
foot
operated,
sensor
operated or have long
handles that can be controlled with the arm or
wrist.
?
洗手设施为非手动的。可以为脚踏式
，感应式或用胳膊或手腕控制的长柄式
? c.
Air dryers or single use sanitary towels
sha
ll be provided.
?
需要有干手器或
1
次性卫生毛巾
? d. Liquid or single use soap
shall be provided.
?
需要有液体或
1
次性肥皂
? e. Signs shall be posted
instructing employees to wash hands before
returning to work.
?
在返回工作前应有指导员工洗手的标示
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
? Refuse, garbage, waste, and debris
from all areas must be promptly and adequately
removed.
?
所有区域的垃圾与废弃物必须立即与适当地清运
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
? a. Refuse receptacles in restrooms
and production areas shall be containers
designated only for refuse.
Modified product containers shall never
be used for refuse.
?
厕所与生产
区域的垃圾容器只能被用于存放垃圾。修整产品的容器不能作为垃圾容器。
? b. Receptacles shall prevent pest
harborage and be covered.
?
垃圾容器必须防止虫害藏匿并带盖子
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
? a. Procedures cover
hazardous waste if needed. Hazardous waste is
handled separately from other waste
streams.
?
需要时建立危险废物的处理程序，危险废物同其他废物分开处理
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
?
a. A job description shall exist and be current
for the sanitation manager (or be part of
individual job
descriptions if duties
are shared).
?
卫生经理的工作描述必须存
在且为当前的。如果职责共享，可以作为个人职责描述的
1
部分
? b. The sanitation
manager and all employees who perform sanitation
shall be knowledgeable and trained
on
all housekeeping/sanitation procedures.
?
在所有总务或卫生程序中卫生经理与从事卫生工作的员工
必须有足够的知识并且被培训
Question 33
111.16
Procedures have been established
for cleaning of the plant.
建立工厂的清洁程序
?
Periodic internal audits of sanitary
practices shall be conducted at a minimum on a
monthly basis.
?
最少每月进行
1
次定期的卫生操作的内部审核
?
b. Written procedures for
maintaining and cleaning of grounds and facilities
shall be written and followed.
Cleaning
of facilities and grounds must be documented.
?
维护与清洁场所与设施的书面程序必须建立与遵守。必须有
清洁设施与场所的记录。
?
c.
A written procedure shall exist and be current
covering facilities (including warehouse, rooms,
areas)
cleaning.
This
procedure
?
shall
cover
the
methods, frequencies
and
chemicals
to be
used
when
cleaning
these areas and
include how the cleaning shall be documented.
?
必须有包含仓库，房间，区域的书面设施清洁程序且为当前的。程序中
清洁这些区域时必须包含方
法，频率，使用的化学品，有如何清洁的记录
?
d.
Procedures
have
been
established
for
waste
handling
and
disposal
frequency
(chemical,
biological,
hazardous, and solid wastes).
?
建立废弃物处理与频率的程序（化学品，生物性，危险性，
固体废弃物）
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
?
A current
Facility Diagram/Floor Plan should be available.
Review the diagram during the inspection.
?
有当前设施图表或平面图。审核时回顾这些图表。
?
b. Plant design in areas
where product is routinely open, shall have
cleanable surfaces. Painted and/or
wood
surfaces should not be used in areas of product or
equipment contact.
?
产品开放的区域
需要有可清洁的表面。油漆或木制品表面不能用于产品或设备接触的表面
?
c. Ledges in product
contact areas shall be minimized to prevent dust
accumulation.
?
产品接触区域的架子必须最小以避免灰尘积累。
?
d. Gowning areas shall be
located at the entrance to required production
areas and should be designed to
prevent
entrance or exit without gown changing.
?
更衣区必须位于需要产品区域的入口，被设计成没有更衣就
不能进出
?
e. Assure
adequate control between areas that have
restrictions and unrestricted areas.
?
在限制区与非限制区确保有足够的控制
?
f. Elevated platforms or
catwalks shall be cleanable and designed to
prevent contamination into processes
located below the platforms.
?
高站台与人行道必须清洁，不能对下面的加工带来污染
?
g. The maintenance shop
area shall be kept in a clean and orderly manner.
The shop should be physically
separated
from production areas so contamination cannot
occur.
?
维修区必须保持干净与整洁。它同生产区域
有实体的隔离以防止污染
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
? All product stored in
warehouse facilities shall be enclosed in tight
fitting enclosures.
?
在仓库内储存的所有产品必须被紧密围住
? b. No product shall be stored on
the floor for prolo
nged periods. All
materials (packing materials, raw
materials, finished products, etc.)
shall be stored at least 6 inches off the floor
(at least at pallet height). All
racking should be at a minimum 12
inches from perimeter and interior walls to
facilitate cleaning.
?
在延长期，不能有产品被直接放在地上。使用材料（包材，原
料，成品等）必须离地
6
英寸（至
少栈
板的高
度）
。所有货架离边界与内墙
最少
12
英寸以利于清洁。
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
? a. Warehouse facilities shall be
devoid of dust and debris and free from pest
indications.
?
仓库与设施必须没有垃圾，灰尘与虫害。
? b. Hazardous chemicals shall not be
stored near ingredients, components or finished
goods.
?
危险性化学品不能靠近组分，配料与成品存放
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
?
a.
Written
procedures
shall
exist
and
be
current
describing
operation
flow
of
goods
and
how/where
goods shall be
stored and segregated. Segregation is adequate
throughout the facility.
?
描述货物操作流程，怎样与在哪里货物被储存与隔离的书面程序必须操作并为当前的。在
整个工厂内，隔
离
是足够的。
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
? a.
Methods for controlling status of goods are used
which may include com
puterized
inventory systems.
?
控制货物状态的方法可以使用计算机化的库存系统
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，贴标签与扣留的区域
?
a.
Procedures
and
controls
must
be
in
place
to
ensure
no
cross-contamination
occurs
between
dietary
supplements and foods, cosmetics or
pharmaceuticals. Cleaning procedures should be
validated.
?
在膳食
补充剂，食品，化妆品与药品之间确保没有交叉污染的程序与控制必须存在。清洁程序应当有效。
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扣
留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
?
a. All rooms where product
contact occurs shall have walls, ceilings, floors
and work surfaces that can be
cleaned
and sanitized. Seams should be minimized in wall
and ceiling coverings.
?
产品接触
的房间必须有能够清洁与消毒的墙面，天花板，地面与工作表面。墙与天花板的接缝应最
小。
?
b. Floor to
wall joints shall be sealed with concave or cove
baseboards or bumpers.
?
地面与墙面的接缝应用凹面，凹脚板或缓冲器密封
?
c. Ceilings shall be
constructed of smooth, non-porous, non-absorbent,
cleanable material. Acoustic tile
ceilings are not to be used in product
contact rooms, the panels shall be FRP or HDPE
grade or equivalent
material. The grid
systems shall be on a cleaning schedule.
?
天花板用光滑的，无孔的，不吸收的，可清洁的材料建造。吸声瓦天花板不能用于
产品接触的房
间，其面板为玻璃钢或高密度聚乙烯或相等的材料。有清洁栅格的计划表。
?
d.
Floors
in
product
contact
areas
shall
not
have
exposed
aggregate,
cracks,
peeling
coating
or
broken
areas. Floors shall be kept clean and
dry.
?
产品接触区域的地面不能有暴露的粒料，裂缝，剥
落的材料或破损的区域。地面保持干净与干燥。
?
e. Ceiling and wall penetrations shall
be sealed.
?
天花板与墙面的穿孔应被密封
?
f. Interior wall and ceiling surfaces
are free from signs of moisture, damage,
insects/pests, mold/mildew,
etc.
?
内墙与天花板表面应没有潮湿，损坏，虫害，霉菌等
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
?
Vents, fans and gratings in product contact areas
shall be on a cleaning schedule.
?
在产品接触区域的通风口，风扇与栅栏有清洁计划
? b. There shall be no evidence of
water leaks.
?
不能有水泄露
? c.
Piping, joists and bracing shall be free of dust
and contaminants.
?
管道，托梁与柱子不能有灰尘与污染物
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
?
a. Excessive dust buildup from powdered products
should be minimized by dust collection.
?
粉状产品的过多粉尘需要使用粉尘收集器减少到最少
?
b. Documented systems
exist to ensure dust collection fines and or
vacuum fines shall not be recycled
into
finished goods.
?
有记录系统确保粉
尘收集器或真空吸尘器的微粒不能再循环到成品内
?
c. Heating and ventilation systems
shall be provided to maintain sanitary conditions.
Condensation on
walls or ceilings shall
be prevented. A PM program shall exist for all
HVAC units
?
加热或通风系统须保持清洁的状态。墙面或天花板的冷凝液不能存在。采暖通风与空调单元需
要
有维护计划。
?
d. Air filtration system must be in
place to prevent cross-contamination or
adulteration of product.
?
必须有空气过滤系统以预防交叉污染与产品的掺杂。
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
? a. If temp and humidity is
monitored, then ranges shall
be
established and documented corrective actions
implemented if temperature deviates
from accepted range. Such devices shall be part of
calibration or PM
programs.
?
如果监控温度与湿度，必须建立
监控的范围。如果温度偏离接受的范围，必须有书面的完成的更
正行动。这
些设备必须为校正或维修计划的一部分。
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 lighti
ng 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
< br>等）
? a. All lighting in
areas with exposed product shall be shatter proof.
Shatterproof includes pl
astic bulbs or
glass bulbs fitted with plastic
shields.
?
暴露产品区域的所有灯必须有防破损
装置。防破损装置包括带有塑料球或塑料罩的玻璃灯。
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
? a. All tanks and
hoppers shall be equipped with lids or covers.
Tanks and hoppers shall be covered when
not actively being filled.
?
所有缸与储料器必须配有盖子。不使用时，所有缸与储料器必须盖上盖子。
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）
? a. No harborage areas exist and
facility is
tidy and orderly.
?
没有虫害藏匿的区域，工厂是整洁与有序的。
Question 50 CFR 111.23
Records have been maintained for plant
cleaning, pest control, and water quality (where
required) and in
accordance
withSubpartP
.
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
? a. Procedures have
been
established for cleaning of rooms
and areas including frequency, inspection, and
approved cleaning materials.
?
应建立包含频率，检查与批准的清洁材料的房间与区域的
清洁程序。
? b. All cleaning is
documented.
?
记录所有的清洁
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
? a. Water test results
are kept and current based on testing procedures
(water as a component must have
test
results from point of use).
?
< br>根据测试程序，保留水的测试结果并为当前的。水作为组分时，必须有从使用点的测试结果。
SUBPART
D
设备与器具
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
?
a.
Written
procedures
shall
exist
and
be
current
for
all
equipment
(laboratory
and
production)
calibrations.
These procedures should describe the
frequency of testing, the testing method and the
acceptable range of
variation.
?
所有
实验室与生产区域的设备必须有书面的校正程序且为当前的。这些程序应包含测试的频率，
方法与可接
受的偏差范围。
?
b.
Procedures
should
include
calibration
before
each
use
and
documented
corrective
actions
for
equipment that must be
repaired or replaced.
?
程序
应包含每次使用前的校正，设备被维修或更换时必须有书面的更正行动。
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
? a. Written procedures shall exist
and be current detailing the cleaning, sanitizing
and storing procedures
for
all
equipment
and
utensils.
Procedures
shall
include
methods,
chemical
usage
and
dilutions
and
frequencies.
?
所有设备与器具详细的清洗，消毒与储存的书面程序应被建立
并为当前的。程序应包含方法，化
学品的使用
与稀释，频率等。
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
?
a. The plant shall have a documented
preventative maintenance program. The program
shall designate
equipment with unique
identifiers (equipment numbers). The program shall
outline what activities shall be
completed for the preventative
maintenance and the frequency the maintenance
shall occur. The system
can be
paperless, but adequate records shall show that
the maintenance was completed as scheduled based
on the established frequency.
?
建立
书面的预防性维修计划。计划应指明带有唯一标示的设备。计划应列出预防性维修的活动与
维修的频率。该系统可以不用纸，但须有足够的记录表明维修是按照计划的频率完成。
?
b.
The
PM
program
shall
include
auxiliary
equipment
such
as
HVAC
units,
dust
collectors,
boilers,
air
compressors and water
treatment systems.
?
该计划应
包含辅助的设备，如采暖通风与空调单元，灰尘收集器，锅炉，空压机，水处理系统。
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
? a.
Equipment and utensils that are product contact
shall be smooth, inert, imp
ervious,
non-toxic and
corrosion resistant.
?
产品接触的设备与器具应光滑，惰性的，密封的，无毒
与防腐蚀的
? b. No wood handled
or wood part utensils are to be used (including
mops, squeegees and brooms).
?
不使用木柄或木制器具，包含拖把，扫帚。
? c. Non
-cleanable
materials such as cardboard and tape should not be
used.
?
象纸板，带子等不能清洁的材料不能使用。
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
? a. Condensation,
metal fragments or excessive lubrication shall be
kept from entering the product.
?
冷凝液，金属碎片与过多的润滑油不能混入产品
? b. Equipment shall be free of
flaking paint, rust or other contaminants that
could become detached and
adulterate
the product.
?
设备不能有剥落的油漆，铁锈或其他分开与掺杂产品的污染物。
? c. Temporary repairs are allowable,
but permanent repairs shall be made
promp
tly. Tape, wire, string,
cardboard are not
?
acceptable materials for temporary
repairs.
?
允许临时
性维修，但应迅速进行永久性维修。带子，金属丝，绳子，纸板不能用于临时性维修。
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
?
a. Conveyor belts shall be impervious,
non
-absorbent and cleanable. Belts
shall be in good condition with
no
signs of wear, holes or frayed edges.
?
输送带应密封，不吸收和可清洁。输送带有好的状态，不能有磨损，洞或磨损的边缘。<
/p>
? b. Gasket material that
is product contact shall be non
-toxic,
non-absorbent, easily cleanable, intact and
in good conditions.
?
产品接触的垫圈应无毒的，不吸收的，易清洗，完整的，有好的状态。
? c.
Records of gasket
maintenance shall be kept as part of PM program.
?
垫圈维护的记录应作为预防维修计划的一部分。
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
?
If tools must
be used on equipment during production then the
tools shall be clean and prevent cross
contamination.
Tools
are
not
to
be
stored
on
top
of
equipment,
ledges
or
electrical
boxes
but
should be
stored in cabinets or outside of
product contact areas.
?
如果工具
在生产时用于设备，工具必须清洁并预防交叉污染。工具不能存放在设备，架子或电器柜
顶部，应放在柜子内或产品接触区域的外面。
?
b. Storage of cleaned equipment and
utensils shall preclude adulteration from other
activities in the area
or airborne
contamination.
?
清洁的设备与器具储存时
应防止在该区域内其他活动的掺杂或空气污染。
?
c. Utensils for cleaning or for product
contact shall have specific, convenient and
sanitary storage hangers
or shelves.
Items shall not be stored on the floor, pallets or
against painted surfaces.
?
清
洁使用或产品接触的器具应有明确的，方便与卫生的储存架；不能放在地面上，垫板上或靠在油
< br>漆的表面。
?
d.
Mops are not to be stored in water but hung up to
dry after use. Mop heads shall be part of cleaning
schedule.
?
拖把使用后
不能放在水里，应悬挂沥干。拖把头应作为清洁计划的一部分。
?
e. Water or air hoses
shall be stored off the floor. Product transfer
hoses shall be drained, stored off the
floor and capped.
?
水或空气管离开地面存放。产品转
移管应排空，离地存放并被盖好。
?
f. Brooms should not be a source of
contamination and should be designated for area of
use.
?
扫帚不能成为污染源，只在指定区域使用
?
g.
Facilities
and/or
equipment
and
utensils
shall
be
designed
to
prevent
product
or
product
contact
surfaces from coming in contact with
non-product contact areas such as floors and
walls.
?
工厂，设备与器具设计成预防产品或产品接
触面与地面与墙面等非产品接触面的接触
?
h. Bulk unload hose systems shall be
labeled, capped and secure.
?
散装卸货管道系统应有标签，盖住并安全
?
i. Ancillary piping should
be labeled as to contents to prevent wrong
connections.
?
辅助管道应用标签，预防内容物的错误连接。
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
?
a.
Equipment
welds
and
seams
shall
be
polished
and
smooth
to
prevent
accumulation
and
facilitate
cleaning.
?
设备的焊接与接缝应被抛光与光滑，以预防积累，利于清洁。
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
?
a. Inspect the equipment
interior for damage, rusting, rouging (in
stainless steel equipment), pitting or
gouging,
stains,
uncleanliness,
?
etc.
Interior
surfaces
should
be
clean,
smooth
(seamless)
and
in
good
condition.
?
对设备内部进行损坏，生锈，铁粉（不锈钢设备）
，蚀损斑，污
点，不清洁等的检查。内表面应干
净，光滑，无缝并有良好状态。
?
b. Inspect the equipment exterior for
damage, peeling paint, debris, dust, oils, spilled
chemicals/materials,
etc.
Exterior
surfaces
should
be
well
maintained,
clean,
and
should
not
be
a
source
of
possible
contamination.
?
对
设备外表面进行损坏，油漆剥落，碎片，灰尘，油污，溢出的化学品与材料等。外表面应良好维
< br>护，干净，不能成为可能污染源。
?
c. Inspect all hatch covers, exposed
gaskets, etc. for damage, cleanliness, etc.
?
检查所有开口盖，暴露的垫圈有无损坏，清洁等
?
d. Equipment shall be
maintained and not show signs of excessive wear.
If excessive wear is seen, then a
maintenance program shall be
established to ensure product is not adulterated.
?
设备应被维护，不能过多磨损。如果有过多磨损，须制定维
护计划以保证产品没有掺杂。
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
?
a. If product
storage requires cold or freezer storage, special
equipment or rooms shall be available. If
cold
storage
units
are
used,
then
alarming
or
regulating
temperature
devices
are
required.
Temperature
record
logs
shall
be
kept.
Temperature
ranges
shall
be
established
and
documented
corrective
actions
implemented if
temperature deviates from accepted range. Such
devices shall be part of calibration or PM
programs.
?
如果产品需
要冷藏或冷冻储存，则需要提供特定的设备或房间。如果使用冷藏单元，须有报警或温
度
调节设
施。需要保存温度记录日志。建立温度范围，如果温度
偏离可接受的范围，需要有书面的
更正行动完成的记
录。这些设施为校正或预防维修计划的一部分。
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。
?
a. Instruments (laboratory
and operational) shall be part of a calibration
and/or PM program. Ancillary
gauges,
instruments, etc. are appropriately installed for
function and calibrated.
?
实验
室与生产的仪器必须为校正或预防维修计划的一部分。辅助的量表，仪器被适当地安装以保证
其功能与校正。
?
b.
Calibration records shall include
?
1. Identity of instrument or control
?
2. Date calibration is
performed
?
3. Identity and
certification of compliance of any reference
standard
?
4. Calibration
procedure that was used including the calibration
limits or specifications
?
5. Calibration readings or readings
found
?
6. Recalibration
method and readings found (if required)
?
7. Initials of the person
performing the calibration
?
校正的记录应包括
仪器的识别；
完成校正的日期；
符合参考标准的识别与证书；
包含校正限值与规格的校正程序；
校正的读数或发现的读数；
再校正的方法与读数；
完成校正的起始人
?
Annual
calibration
of
operational
equipment,
measuring
and
metering
devices
such
as
thermometers,
scales, flow
meters, timers, speed controls, HPLC, GC, AA,
metal detectors, etc. shall be properly completed
to assure their accuracy. Equipment
shall be calibrated on a frequency that is
justified by data, taking into
account
the type of equipment in
question
and the required
accuracy and precision you need based on how
you will be using it.
?
温度计，天平，流量计，定时器，速度控制器，高效液相色谱，气相色谱，原子吸收，金探等操作< /p>
性设备，测量设施必须每年校正以保证准确性。设备必须按照证明有效的频率完成校正；这
由有疑
问设备的类型，需要的准确度与怎样使用的精度来决定。
?
d. Scales shall be
calibrated by a certified individual at least
annually.
?
至少每年有资质的人员完成天平的校正。
?
e.
Scales
shall
be evaluated
at
appropriate
weights
prior
to
use.
These
checks
(recording
the
observed
weights) shall be
documented.
?
使用前天平被用适当的砝码评估。必须有观察重量的检查记录。
?
f. Test weights shall be
calibrated by a certified contractor at least
annually, or whenever they are dropped
or damaged. Records shall be available.
Test weights shall be stored properly off the
floor. They should be
stored in
cabinets or shelves where they are protected
against water or potential damage.
?
至少每年，或损坏时有资质的承包商对测试砝码进行校正。保留测试的记录。测试砝码离地存放
。
他们被存放在防水或防止潜在损坏的柜子或架子内。
?
g.
Checks
of
intermediate
thermometers
against
NIST-traceable
standards
shall
be
performed
at
a
frequency
commensurate
with
the
use
of
the
intermediate
thermometer,
but
at
least
annually.
Full
documentation of the calibration of the
intermediate thermometers shall be available.
?
同使用媒介温度计相称的频率，但至少每年一次按照国家标准技术协会
可追溯的标准对媒介温度计
进行校正。应当保存媒介温度计校正的全部记录。
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
?
a.
Compressed
air
shall
be
trapped
for
co
ndensation
at
points
of
use.
Air
dryers
may
be
used.
All
components (including
traps) should be part of PM program. If compressed
air is product contact testing
should
be completed for micro contamination. If
compressed air is used in cleaning, the last step
prior to
use should be a sanitizing
step or micro testing should be completed.
?
在使
用处压缩空气应被截留冷凝液。空气干燥器也可以使用。所有组分包括截留器应为预防维修
计划的一部分。如果压缩空气同产品接触，需要测试微生物的污染。如果压缩空气用于清洁，在使
用前的最后
1
步应为
消毒或测试微生物。
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。
?
a.
Documentation
of
major
equipment
cleaning
must
be
kept.
Documentation
should
include,
date,
reference cleaning methods, who
performed the cleaning and effectiveness checks.
?
必须保留主要设备的清洁记录。记录包括日期，清洁方法，
操作人与有效性的检查。
?
b.
Cleaning procedures shall be verified and
inspected. If visual inspection is difficult or
impossible then
supplement
bioluminescence or microbial testing should be
used. Deficiencies and corrective action shall be
documented and followed up. Final rinse
water for tanks or large vessels should be
evaluated to determine
if chemical
residue has been effectively flushed (water
clarity, pH, odor).
?
应当验证与检查
清洗程序。如果目测困难或不可能，需要进行生物荧光或微生物测试。必须记录与
跟进差
异与更正行动。评估缸或大容器的最终冲洗水是否化学残留被有效冲洗（水透明度，
PH
，气
味）
?
c.
A
final
(or
pre-start
up)
sanitizing
step
on
all
product
contact
surfaces
is
required.
Reusable
towels
should not be used during the
sanitizing step.
?
所有产品接触面的最
终或开始前的消毒步骤是需要的。再次使用的毛巾不能用于该消毒步骤。
?
d.
Equipment
and
utensils
shall
be
cleaned
prior
to
contact
with
different
products
where
cross
contamination could
occur. For example scoops cleaned during weigh up
to prevent cross contamination in
bulk
containers.
?
交叉污染可能发生的在接触不同产
品之前的设备与器具需要清洁。如散装容器内的铲子在称重时需
要清洁以预防交叉污染。
?
e. Cleaning of
equipment and utensils shall be conducted to
prevent contamination from chemical residue.
?
需要指导设备与器具的清洁，以预防化学品残留的污染。
?
f. All equipment taken out
for maintenance shall have documented cleaning and
sanitizing steps prior to
putting back
in service.
?
使用做维修的设备在使用前必须有书面的清洗与消毒记录。
?
g. Equipment and utensil
status must be clearly indicated.
?
必须明确标明设备与器具的状态
?
h. Storage of cleaned equipment must
preclude contamination.
?
清洁后设备的储存必须防止污染。
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
? a. Equipment shall be designed to be
disassembled or easily cleaned in place. Equipment
shall be self
-
draining.
?
设备应设计成可拆卸或易于就地清洁。设备必须自排水。
? b. Equipment shall be installed so
that it can be cleaned around and under. In some
cases equipment may
need to be
removable.
?
设备安装时能保证在四周或下面
进行清洁。有时设备可以被移动。
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。
? a. Low
moisture areas must remain dry when in use. Dry
cleaning is acceptable as long as a sanitizing
step
is performed.
?
使用时低水分区域必须保持干燥。只要消毒步骤完成后，
可以接受干清洁。
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
< br>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
?
a. Procedures must be
established and followed for cleaning of other
process areas (non-product contact).
?
对非产品接触区域应建立并遵守清洁程序
?
b.
Dust
collection
systems
shall
be
part
of
cleaning
schedule.
Dust
hoods
or
hoses
directly
above
or
adjacent to product shall be maintained
clean at all times and not provide a source of
cross contamination.
?
灰尘收集器应作为清洁计划的一部分。直接在产品上方或临近
的灰尘罩子或软管应一直保持清洁
,
不能成为
< br>
交叉污染的来源。
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
? a. Food grade (as specified on the
label or accompanying docum
entation)
chemicals shall be used in all
product
contact applications (cleaning and maintenance).
?
食品级（标签表明或有证书）化学品可用于所有的产品接
触区域（清洁与维护）
? b. NSF
Registered proprietary substances and
non
-food compounds are acceptable when
used for their
intended purposes.
? NSF
注册拥有的物质与非食品级化合物按预期用途使用
是可以接受的。
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
? a. Portable equipment and utensils
must be stored to prevent airborne
contaminatio
n (usually bagged
once dry). Surfaces used to stored
cleaned equipment must be sanitary.
?
轻便的设备与器具储存时预防空气污染（通常干燥后袋装）
。储
存清洁的设备的表面应卫生的
? b. All
reusable product containers shall be effectively
cleaned, sanitized and inspected prior to
use.
Storage of containers
shall prevent contamination.
?
所有可再使用的产品容器在使用前应被有效地清洁，消毒与检查。容器储存时应避免污染。
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
?
a.
Equipment
de
sign
ensures
operation
to
meet
product
specifications.
Such
as
timing
devices
on
blenders.
?
设备设计时应满足操作时产品的规格。如搅拌器上的调速装置。
? b. Automated, mechanical, or
electronic equipment is operated within operating
limits and is used for its
intended
purpose.
?
自动的，机械的与电子的设备在操作
限值内操作并按预期用途使用。
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
? a. Procedures and controls are in
place for changes implemented
in
operations. Changes are approved by
the
Quality Unit. Changes may include removing or
installing new equipment.
?
操作中变化完成的程序与控制应在现场。变化应得到质量小组的批准。它包括去除或安装新设备。
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。
?
a.
In
addition,
a
system
for
determining
and
repairing
maintenance
issues
prior
to
contamination
problems
arising shall exist (such
? as a GMP
audit, pest activity reports, housekeeping audits
etc.).
?
在污染问题发生
前应有判断与修理维护系统（如
GMP
审核，虫害活动报告，总
务审核等）
? as a GMP audit,
pest activity reports, housekeeping audits
etc.).
?
在污染问题发生
前应有判断与修理维护系统（如
GMP
审核，虫害活动报告，总
务审核等）
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）
?
as a GMP audit, pest activity reports,
housekeeping audits etc.).
?
在污染问题发生前应有判断与修理维护系统（如
GMP
审核
，虫害活动报告，总务审核等）
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）
?
Chronological
records
shall
be
kept
that
enable
research
into
all
activities
performed
on
equipment
or
areas surrounding
?
production of a batch of product.
Records should include names, dates, batch numbers
and activities (production, cleaning,
maintenance) performed. Logbooks or batch records
may be used to
keep this data as long
as the complete history of the batch can be
determined.
?
需要保留序时记录以保证在
1
批产品涉及的设备或产品周围区域的活动被调查。记录包括名称，日
期，批号与完成的活动（生产，清洁，维护）
。日志或批记录可
以用于保存这些数据，只要批完成批
记录的历史被确定。
?
b. Logbooks if used shall
be kept up to date and completed as close to real
time as possible.
?
使用的日志应最近的保存，尽可能靠近真正时间去完成。
?
c. If maintenance occurs
as part of daily set up or in other operational
functions, this maintenance shall
also
be logged including operator, date, maintenance
performed/chemicals used.
?
如
果维修作为每日计划或其他操作职责的一部分，可以使用包括操作者，日期，完成的维护，使用
< br>的化学品的日志。
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
? a. Calibration and PM records are
available for review
?
校正与预防维护计划应保留以便于回顾
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.
?
< br>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。
?
PRODUCTION AND PROCESS CONTROL
SYSTEM
?
E
生产与过程控制系统
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
? a. Controls exist at all critical
stages of manufacturing through packaging and
labeling to ensure product
meets
quality specifications and is produced according
to the MMR.
?
通过
包装与贴标签的所有生产的关键步骤应被控制，以确保产品满足质量规格，并根据加工手册
完成生产。
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
? a. Critical
control steps are written, part of the MMR and
have been approved by quality.
?
关键控制步骤是书面的，为加工手册的一部分，并被质量批准
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
?
a. Quality personnel a
re responsible
for the following duties:
?
1. Approving/rejecting processes,
specifications, procedures, controls, tests,
results and deviations
?
2.
Approving documentation for supplier qualification
?
3.
Approving
documentation
for
ensuring
dietary
supplements
meet
identity,
strength,
purity
and
composition specs.
?
4. Approving test results
?<
/p>
质量人员有以下的职责：加工，规格，程序，控制，虫害，结果与偏离的批准与拒绝；供应
商资格
的批准文件；批准保证膳食补充剂满足特性，功效，纯度，成分规格的文件；批准
测试结果。
?
5.
Oversight of sampling and retain programs
?
监督取样与保留的计划
?
6. Determining if
specifications are met
?
决定是否满足规格
?
7. Reviewing and approving
documentation, documentation practices and
revisions
?
回顾与批准文件，文件的实施与修订
?
8. Managing and reviewing
change to documents, equipment, facilities
?
管理与回顾文件，设备与设施的改变
?
9. Performing audits and
implementing corrective actions
?
完成审核与更正行动
?
10. Ensuring procedures are followed
and the most current revisions are in place
?
保证遵守程序；最当前的修订在现场
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
?
a. Specification for
finished product and packaged finished product may
be the same
?
成品与包装完成的产品规格可以相同
?
b. Specifications for in
process steps/products may not be needed if
adequate finished product specs have
been established
?
如果建立了足够的成品规格，加工中步骤或产品的规格可以不需要
?
c. Categories of products
or components may have the same specifications.
?
产品或成分的种类可以有相同的规格
?
d. Specifications must
have limits.
?
规格必须有限值
?
e. Ingredients must have an identity
specification
?
配料必须有识别的规格
?
f.
Identity,
purity,
strength
and
composition
of
the
finished
product
must
be
established
by
either
in
process
specs or finished product specs
?
通过加工的规格或成品的规格，必须建立成品的特性，纯度，功效，与组成
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
?
a. Testing plans and protocols must be established
to ensure specifications are met. At a minimum raw
materials and finished products must
have established testing plans and protocols.
?
建立测试计划与草案以保证满足规格。最低要求原料与成
品必须有测试计划与草案。
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
?
a. All ingredients must be
tested to verify identity. Organoleptic testing
can only be used if the product can
be
positively
identified
by
this
method
(organoleptic
testing
of
chopped
herbs
for
example
is
not
acceptable).
?
使用配料被测试以验证特性。感官测试仅仅被用于如果产品能被这种方法肯定识别（如
不能接受对
切碎药草的感官测试）
?
b. Ingredient specifications and/or
labels indicate accurate shelf life (if
applicable). A system is in place for
ensuring that expired ingredients are
not used in production. This includes first in
first out procedures and
procedures for
managing raw material expiration or retesting.
?
可行时原料规格与标签表明正确的保质期。有保证过期原料不能用于
生产的系统。这包括先进先出
的程序与管理原料过期与再测
试的程序。
?
c. Approved raw materials shall be
rotated so that the oldest approved stock is used
first. These should
also include
procedures for periodic assessment of the
inventory to assure that no adverse conditions
exist.
?
批准的原料应被回转以保证早先批准的库存先
使用。这包括定期评估库存的程序以保证没有有害情
况存在
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
? a. COA’s
may be used for confirming all specifications
except identity. COA’s must include description of
the test used, limits and actual
results.
?
除特性外，分析报告可以用作确认所有
规格。分析报告必须有使用的测试，限值与实际结果的描
述。
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
? a. COA’s may only be used for
confirming specifications
if the
supplier has been qualified.
?
如果供应商有资格，分析报告仅被用于确认规格
? b. Supplier qualification programs
require at a minimum:
? 1.
A documented process reviewed and approved by
quality
? 2. The supplier
COA results to be confirmed
? 3. Periodic
re
-qualification and disqualification
procedures
?
供应商资格计划的最低要求为：质量的书面的加工回顾与批准；供应商分析报告的确认；定期
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
?
a.
A
program
for
verifying
finished
product
meets
established
specifications
must
be
established.
The
program may use a skip lot system. The
program may use testing results of raw materials
and/or in process
materials in lieu of
testing finished product.
?
建
立验证成品满足制定规格的计划。计划可以使用跳跃批号系统。计划可以使用原料与加工材料的
< br>测试结果代替成品的测试
?
b.
At
least
one
component
of
the
finished
product
must
be
tested
for
identity,
purity,
strength
or
composition. This may be part of the
skip lot system. If the finished product cannot be
tested, raw material
and/or in process
test results may be used to show finished product
compliance.
?
1
种成品
组分的测试至少有特性，纯度，功能或组成。这可以是跳跃批号系统的一部分。如果成品
不能测试，原料与加工过程的测试结果可以表明成品的符合性。
?
c. Justification for the
testing program and any exemptions must be kept.
?
必须保留测试计划的理由与任何豁免。
?
d. Quality Control must
review and approve the documentation.
?
质量控制必须回顾与批准这些文件。
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.
有包装与标签材料感官检查后，最低要求再回顾供应
商的发货单以决定是否满足规格
? a.
Procedures are established and followed for
receipt of packag
ing goods and labels.
Inspection of the
component or label is
required.
?
建立接收有包装货物与标签的程序
并遵守该程序。需要检查组分或标签。
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 91 CFR 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
? a.
Scientifically valid methods are used for
establishing that specifications have been
met.
?
使用科学的验证方法来建立是否满足规格
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
? a. Procedures have been established
and are followed for handli
ng OOS
results or product and deviations.
?
建立并遵守处理不满意结果或产品与偏离的程序
? b. Rejected components, finished
product or bulk product has not been used or
distributed. Exceptions
may apply for
reprocessed materials. All exceptions must follow
deviation procedures and be approved by
quality.
?
拒绝的组分，成品或散装产品不能使用或分发。请求再次加工
的材料可以例外。所有的例外必须
遵守偏离程
序并被质量批准。
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
? a. A statistically significant
sampling progr
am shall be written and
followed for collecting samples without
introduction of contamination.
?
建立并遵守没有污染样品收集的统计的重要取样计划
? b. All unique lots of ingredients,
in
-process product, packaging
components, labels, received bulk finished
goods, finished goods and packaged
finished goods shall be sampled. Documented skip
lot programs can be
used for all
sampling except raw materials.
?
取所有唯一批号的配料，加工产品
，包材，标签，接收的散装产品，成品与包装的成品的样品。
除原料外，
书面的批号跳跃计划可被用于其他采样。
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。
?
a. A procedure has been established for
collection and storage of retain samples. Only
finished products
retains are required
(raw materials are optional).
?
建立收集与储存留样的程序。只需要成品的留样（原料留样是选择性的）
?
b. Retain procedures
include:
?
1. Container
closure system (same or equivalent to finished
product packaging).
?
2. Retains must be identified for lot
traceability
?
3. Storage
conditions and time requirement (1 year plus shelf
life or 2 years past distribution of last batch)
?
4. Quantity of sample (at
least twice quantity necessary for conducting all
tests)
?
留样程序包括：容器密封系统（相同或相等的
成品包装）
；有批号追溯性的标示；储存条件与时间
的要求（保
质期后
1
年或最后
1
< br>批上次分发后
2
年）
；取样的数
量（至少进行所有测试
2
倍的数量）
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
?
a.
Procedures
exist
for
recording,
in
vestigating
and
implementing
corrective
actions
when
deviations
occur.
?
当偏差发生时，建立记录，调查与完成更正行动的程序。
? b. Procedures should exist for
handling emergencies.
?
建立处理紧急事件的程序
Question 97 CFR 111.90a
Reprocessing
controls
have been established
and
meet all
requirements
and
have been
approved
by
the
Quality
ControlUnit.
再加工应被控制，满足要求，并被质量控制小组批准
? a. Reprocessing or reworking
procedures have been established for production,
packaging and labeling
operations.
These procedures have been reviewed and approved
by quality.
?
建立生产，包装与贴标签的
再加工或返工程序。该程序应被质量回顾与批准。
?
b. Review reprocessing or reworking records.
Verify traceability and controls were in place.
Verify quality
approved
the
work
prior
to
commencement.
Verify
that
the
completed
batch(s)
were
reviewed
for
specification compliance and released
by quality.
?
<
/p>
回顾再加工与返工的记录。验证可追溯性与适当地控制。在开始时，验证质量批准的工作。
验证
完成的批被
回顾规格符合性与被质量放行。
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
? a. Procedures outlining the receipt,
sampling, testing and approval/rejection of all
raw materials and
bulk
-
finished goods have
been established. Records are kept.
?
建立所有原料与散装产品接收，取样，测试，批准与拒绝的程序并保留记录。
?
b. Procedures
outline the sampling, testing and
approval/rejection of all in process and finished
goods
have been established. Records
are kept.
?
建立所有加工与成品取样，测试，
批准与拒绝的程序并保留记录。
?
PRODUCTION
AND
PROCESS
CONTROL
SYSTEM:
REQUIREMENTS
FOR
QUALITY CONTROL
?
生产与过程控制系统
:
对质量控制的要求
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
?
a.
Written
procedures
establish
quality
duties,
responsibilities
and
authorities.
These
duties
are
independent from production.
?
建立书面的质量职责，责任与职权。这些职责同生产独立。
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
?
a. Written procedures have been
established for the following quality duties:
?
建立以下职责的书面程序：
?
1. Approving/rejecting
processes, specifications, procedures, controls,
tests, results and deviations
?
批准与拒绝加工，规格，程序，控制，测试，结果与偏离
? 2. Approving documentation for
supplier qualification
?
供应商资质的批准文件
?
3.
Approving
documentation
for
ensuring
dietary
supplements
meet
identity,
strength,
purity
and
composition specification
?
保证膳食补充剂满足特性，功能，纯度，组成与规格的批准文件
?
4. Approving test results
批准测试结果
?
5. Oversight of sampling and retain
programs
监督取样与留样计划
?
6. Determining if
specifications are met
决定规格是否被满足
?
7. Reviewing and approving
documentation, documentation practices and
revisions
?
回顾与批准文件，文件操作与修订
?
8. Managing and reviewing change to
documents, equipment, facilities
?
管理与回顾文件，设备与设施的变化
?
9. Performing audits and
implementing corrective actions
?
进行审核与完成更正行动
?
10. Ensuring procedures are followed
and the most current revisions are in place
?
保证遵守程序，最当前的修订在现场
?
11. Quality shall maintain
a change control program for all changes that
occur. Document changes shall be
controlled and reviewed.
? <
/p>
对所有发生的变化质量应保持变化的控制计划。文件变化应被控制与回顾。
?
12. Documented
training shall occur on all changes.
?
对所有变化进行书面的培训
?
13. Quality shall approve all
corrective actions relating to quality and ensure
implementation.
?
批准与质量有关的所有更正行动并保证完成
?
14. Quality shall
determine and approve appropriate documentation
practices. All procedures and forms
shall be dated; revision controlled and
signed off by appropriate management. Records and
procedures shall
be reviewed for
compliance at least annually. Appropriate
documentation practices include use of ink, no
use of whiteout, single line through
mistakes initials and date, an X or / through
forms or notebooks that
aren’t used
etc. Obsolete or out of date forms or procedures
shall not be used.
?
< br>决定与批准适当的文件操作。通过适当的管理，所有程序与表格有日期，有修订的控制与完成。至
少每年对记录与程序进行符合性的回顾。适当的文件操作包括使用墨水，不能模糊不清，错误起始
与日期在同一行，表格与记事本不能用
X
或
/
。废弃或过
期表格与程序不能使用。
Question 101 111.110
Quality
Control Laboratory Operations have been
established.
建立实验室质量控制的操作
? a. Quality reviews and approves
test methods and results
?
质量回顾与批准测试方法与结果
?
b. Qualit
y releases or rejects product
based on compliance to established specifications
?
放行与拒绝产品应根据是否符合建立的规格
? c. Quality has established
processes and procedures for laboratory operations
including sample handling,
results
reporting, release/rejection procedures, reference
standard programs and OOS result investigations.
?
对实
验室的操作，质量建立过程与程序，包括采样处理，报告的结果，放行与拒绝程序，参考的
标准计划，不满意结果的调查等。
Question 102 111.113a
Quality
Control
Operations
and
responsibilities
have
included
the
authority
to
reject
any
component
or
product if any specification isnot met.
质量控制操作与职责包括拒绝规格不符合组分与产品
?
a.
Written
procedures establish
that
quality
has
the
authority and responsibility
to
conduct
material
reviews and make
product disposition decisions.
?
质量有权限与职责的书面程序进行材料回顾与对产品处理做决定
? b
. Quality must conduct
a material review and make a disposition decision
if:
?
在以下情况下，质量必须进行材料回顾与做处理决定：
? 1. Specifications are not met
规格不满足
? 2. A
batch deviates from the MMR
批背离主要加工记录
? 3.
There is an unexpected occurrence that could lead
to adulteration or mislabeling
?
导致掺杂或标签错误等意外事情的发生
? 4. Calibration or failure of an
instrument occurs that could effect batch quality
导致批质量的校正或仪器失
效的发生
? 5. A
dietary supplement is returned
膳食补充剂的返回
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
?
a.
Quality
must
approve
all
reprocess
or
rework
procedures
p
rior
to
implementation.
Quality
must
approve all reprocessed
or reworked product prior to release.
?
在完成前，质量必须批准所有的再
加工或返工程序。在放行前，质量必须批准所有的再加工或返
工产品。
< br>
Question
104 111.113c
?
The
Quality
Control
person
responsible
for
making
the
material
review
and
dispos
ition
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
? a. Review of all receiving records
for components, packaging and labeling
materials.
?
回顾所有组分，包材与标签的接收记录
? b. Determination that these
materials conform to specifications
?
决定这些材料符合规格
? c. Approve any
compo
nent, packaging, and label before
it is used in production
?
在任何组分，包材与标签用于生产前须进行批准
? d. Review of testing results,
documentation and visual examinations to ensure
that all specifications have
been met
?
回顾测试结果，文件与视觉检查以保证满足使用规格
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
? a. Quality must review and approve
all Master Manufacturing Records and any
changes.
?
质量必须回顾与批准所有主要加工记录与任何变化
? b. Quality must issue all
batc
h production records.
?
质量必须发行所有批成品的记录
?
c. Quality shall review and approve all completed
batch records prior to product use or
release.
?
在产品使用或放行前，质量必须回顾与批准所有完成的批记录
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
?
a.
A
written
procedure
shall
be
established
and
followed
outlining
the
criteria
for
r
eleasing
product.
Quality shall have
final authority on releasing product.
?
放行产品标准的书面程序必须建立与遵守。在放行产品时，质量有最终的授权。
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
? a. Goods may be released on a
quality
-
approved deviation
if that deviation will not effect the product’s
identity,
label
claim
or
composition.
Examples
of
quality-approved
defects
may
include
changes
to
packaging
approved
by
the
customer.
All
deviations
must
be
supported
with
documentation
including
customer approvals.
?
如果偏离不影响产品特性，标签声
明与组分，商品可以有质量批准偏离的放行。质量批准偏离的
例子可以包
括被客户批准的包装的变化。所有偏离必须得到包括客户批准的文件的支持。
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
? a. Return procedures must be
established and approved by quality. Quality must
approve final disposition
decisions
relating to returns (salvage, redistribution,
reprocessing etc.).
?
退货程序必须建立并被质量批准。质量必须批准与返回（回收
加工，再分配，再加工）有关的最
终决定。
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
? a. Written procedures for the
responsibili
ties of the QC unit are
established and followed.
?
记录并遵守质量控制小组的书面职责
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。
?
a.
Internal GMP audits shall be conducted annually
covering all aspects of the quality control
program.
This includes but is not
limited to sanitation, facilities, pest control,
housekeeping, cleaning, batch records,
product
manufacturing
and
packaging,
preventative
maintenance
and
calibration
programs,
chemical
use
programs,
standard
operating
procedures
and
forms,
deviation
system,
complaint
system
and
laboratory
and
testing
records.
The
audit
should
cover
among
other
things,
the
effectiveness
of
policies,
the
applicability of procedures and the
completeness of corrective action implementation.
?
内部
GMP
审核每年进行一次，应覆盖质量控制计划的全部方面。包括但不限于卫生，设施，虫害
控
制，总务，清洁，批记录，产品加工与包装，预防维修与校正计划，化学品使用计划，标准操作
< br>程序，偏离系统，
投诉系统，实验室与测试记录。审核
应覆盖在其他事情内，政策的有效性，程序
的适应性，更正行动完成的
< br>
符合性。
?
b.
Management
shall
review
internal
audits
and
corrective
action
with
follow
up
completion
shall
be
documented.
?
管理层应覆盖内审，跟进完成的更正行动需要有记录。
?
PRODUCTION
AND
PROCESS
CONTROL
SYSTEM:
REQUIREMENTS
FOR
COMPONENTS,
PACKAGING,
AND
LABELS
AND
FOR
PRODUCT
THAT
YOU
RECEIVE FOR PACKAGING AND LABELING AS A
DIETARY SUPPLEMENT
?
生产与过程控制系统：对成分，包装，标签以及对接收的作为膳食补充
剂包装
与标签产品的要求