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Cosmetic Good Manufacturing Practice (GMP)
Guidelines/Inspection
Checklist
美國化妆品良好生产规范指南
February 12, 1997; Updated April 24,
2008
The
Federal Food, Drug
and Cosmetic Act
1
prohibits
the introduction or delivery for introduction into
interstate commerce of cosmetics that
are adulterated or misbranded (Sec.
301).
联邦食品，药品和化妆品法案（
The Federal
Food, Drug and Cosmetic Act,
以下简称
FD&C
法案
）
禁止
在州际直接贸易的化妆品是掺杂的或贴假标签的情况。
(Sec.
301)
A cosmetic may be deemed
adulterated (Sec. 601) for essentially four
reasons, namely:
以下
4
< br>种情况下，化妆品被认为是可能掺杂的。
(Sec. 601)
1.
It may be
injurious to users under conditions of customary
use because it contains, or its container is
composed of, a potentially harmful
substance.
客户在使用过程中，
由于化妆品本身含
有或在包装容器中有潜在的，
对人体有害的成份而使用
户受到伤
害的。
2.
It contains filth.
本身含有不洁成份的。
3.
It contains a
non-permitted, or in some instances non-certified,
color additive.
本身含有禁用成份，例如：未认可的色素添加剂。
4.
It is
manufactured or held under insanitary conditions
whereby it may have become injurious to users
or contaminated with filth.
在不卫生条件下生产的，或保留的，可导致产品伤害用户有害或被不洁成份所污染。
A cosmetic may be deemed misbranded
(Sec. 602) for reasons of:
以下几种情况下，化妆品被
认为可能会认为贴假标签。
(Sec. 602)
1.
False or
misleading labeling.
虚假的标签或存在误导信息的标签。
美国化妆品良好生产规范指南
1
Cosmetic Good
Manufacturing Practice (GMP)
Guidelines/Inspection
Checklist
2.
Failure to state prominently and
conspicuously any information required by or under
authority of this
act.
显着违反了
联邦食品，药品和化妆品法案的要求在标签上声明的信息要求。
3.
Misleading
container presentation or fill.
在容器上有误导的信息。
To
determine whether cosmetic firms manufacture, hold
or deliver for introduction into interstate
commerce
cosmetics that are adulterated
or misbranded, and to prevent these and other
practices violating Sec. 301 of the
FD&C Act, the law gives the agency the
authority to enter the establishments of such
firms and inspect their
facilities as
well as all pertinent equipment, finished and
unfinished materials, containers and labeling
therein.
See Sec. 704(a) of the FD&C
Act.
为了确定化妆生产厂家是否保留或发货了掺杂的，
或
是贴假标签的化妆品，
和防止这些违反了
FD&C
法案生产的化妆品流入市场，法律给了
FDA
进入这
些化妆品工厂检查的权利，包括检查相关工厂的
设备，成品，原料，容器和标签。（见<
/p>
Sec.704
（
a
）
of the FD&C
Act
。）
Rigorous
adherence to good manufacturing practice minimizes
the risk of adulteration or misbranding of
cosmetics. The following cosmetic
establishment instructions, excerpted from FDA's
Inspection Operations
Manual, may serve
as guidelines for effective self-inspection. A
good inspection score means that an
establishment follows good
manufacturing practice.
如果工厂严格的根据良好的操作规
范（
GMP
）的要求生产，将最低限度的减少掺杂的或贴假标签
的
情况。随后的化妆品指导，引用于
FDA
检查操作手册（
FDA's Inspection Operations Ma
nual
），可以
作为指南，
用来有效
的进行自我检查，
除良好的检查得分则意味着工厂执行了良好操作规范
< br>（
GMP
）
的要求。
Guidelines
指南
1.
Building and
Facilities.
Check whether
建筑物和设施：
检查是否
a.
Buildings used
in the manufacture or storage of cosmetics are of
suitable size, design and
construction
to permit unobstructed placement of equipment,
orderly storage of materials,
sanitary
operation, and proper cleaning and maintenance.
美国化妆品良好生产规范指南
2
Cosmetic Good
Manufacturing Practice (GMP)
Guidelines/Inspection
Checklist
用于生产或存放化妆品的建筑物应大小合
适，
设计和结构应保证设备进出不受阻碍，
材
< br>料存放整洁，操作卫生以及正确的清洁和维护。
b.
Floors, walls
and ceilings are constructed of smooth, easily
cleanable surfaces and are kept
clean
and in good repair.
地面，墙壁和天花板结构表面应光滑，易于
清洁，并保持干净和良好状况。
c.
Fixtures, ducts and pipes are installed
in such a manner that drip or condensate does not
contaminate cosmetic materials,
utensils, cosmetic contact surfaces of equipment,
or finished
products in bulk.
安装的固定位置，
管道的滴水或者冷凝水不会污染化妆品原料，
器具，
以及与化妆品原
料，散装产品或成品接触的设备的表
面。
d.
Lighting and ventilation are sufficient
for the intended operation and comfort of
personnel.
照明和排风系统应满足预期员工操作和舒适的要求。
e.
Water supply,
washing and toilet facilities, floor drainage and
sewage system are adequate for
sanitary
operation and cleaning of facilities, equipment
and utensils, as well as to satisfy
employee needs and facilitate personal
cleanliness.
供水，
清洗和卫生设施，
地面排水和废水系统应充分满足清洁操作的要求，
和设备，
器
具的清洁要求，以及满足员工的需要并易于让员工保持个人清洁。
2.
Equipment.
Check whether:
设备
：检查是否
a.
Equipment and
utensils used in processing, holding, transferring
and filling are of appropriate
design,
material and workmanship to prevent corrosion,
buildup of material, or adulteration
with lubricants, dirt or sanitizing
agent.
加工，
盛放，
中转和灌
装过程使用的设备和器具应设计合理，
使用的材料和工艺能防止
腐蚀，污垢的堆积，以及被润滑油，灰尘或者消毒剂污染。
b.
Utensils,
transfer piping and cosmetic contact surfaces of
equipment are well-maintained and
clean
and are sanitized at appropriate intervals.
美国化妆品良好生产规范指南
3
Cosmetic Good
Manufacturing Practice (GMP)
Guidelines/Inspection
Checklist
器具，运送管道以及和化妆品接触的设备
表面应维护良好，并定期清洁和消毒。
c.
Cleaned and
sanitized portable equipment and utensils are
stored and located, and cosmetic
contact surfaces of equipment are
covered, in a manner that protects them from
splash, dust or
other contamination.
清洁和消毒后的便携式设备和器具应妥善放置，
与化妆品接触的设备
表面应罩住，
防止
飞溅，灰尘或其他污染物。
< br>
3.
Personnel.
Check whether:
员工：
检查是否
a.
The personnel
supervising or performing the manufacture or
control of cosmetics has the
education,
training and/or experience to perform the assigned
functions.
监督化妆品的生产或者控制的员工应具
有一定的教育背景，培训和
/
或经验来执行制定
的监督工作。
b.
Persons coming into direct contact with
cosmetic materials, finished products in bulk or
cosmetic contact surfaces, to the
extent necessary to prevent adulteration of
cosmetic products,
wear appropriate
outer garments, gloves, hair restraints etc., and
maintain adequate personal
cleanliness.
为防止化妆品掺杂，
与化妆品原料，
散
装成品或化妆品接触表面直接接触的员工，
应穿
戴合适的工作服
，手套，头套等，并保持良好的个人清洁。
c.
Consumption of
food or drink, or use of tobacco is restricted to
appropriately designated areas.
吃东西，喝水，或抽烟都应严格限制在制定的区域。
4.
Raw
Materials.
Check whether:
原料：
检查是否
a.
Raw materials
and primary packaging materials are stored and
handled in a manner which
prevents
their mix-up, contamination with microorganisms or
other chemicals, or
decomposition from
exposure to excessive heat, cold, sunlight or
moisture.
美国化妆品良好生产规范指南
4
Cosmetic Good
Manufacturing Practice (GMP)
Guidelines/Inspection
Checklist
原料和初级包装材料在储藏和处理时应防
止它们混淆，
被微生物或化学物质污染，
或者
< br>暴露在过度热
/
冷
/
阳光
/
潮湿的环境下而造成腐败变质。
b.
Containers of materials are closed, and
bagged or boxed materials are stored off the
floor.
容器应保持密闭，袋装或盒装的材料应离地存放。
c.
Containers of
materials are labeled with respect to identity,
lot identification and control status.
容器上应有标签，说明批次和控制状况。
d.
Materials are
sampled and tested or examined in conformance with
procedures assuring the
absence of
contamination with filth, microorganisms or other
extraneous substances to the
extent
necessary to prevent adulteration of finished
products. Pay particular attention to
materials of animal or vegetable origin
and those used in the manufacture of cosmetics by
cold
processing methods with respect to
contamination with filth or
microorganisms.
根据程序的要求对原料进行
抽样和测试，
确保没有受到污染，
微生物或者其他外界物质
的污染，
以对防止成品的掺杂。
应特别主要
来源自与动物或植物的原料，
或那些用冷加
工方法生产的化妆品
可能被污物或微生物污染的情况。
e.
Materials not
meeting acceptance specifications are properly
identified and controlled to
prevent
their use in cosmetics.
不符接收标准的原料应正确标识和
控制，以防止他们使用在化妆品中。
5.
Production.
Check whether
manufacturing and control have been established
and written instructions,
i.e.,
formulations, processing, transfer and filling
instructions, in-process control methods etc., are
being maintained. Determine whether
such procedures require that:
生产：
检查是否已经建立制造和控制的程序，
并有书面的工作指导书。
也就是，
已制定了配方，
加工过程，周转和灌装，以
及加工中的控制方法等的作业指导书。确定这些程序是否要求。
a.
The equipment
for processing, transfer and filling the utensils,
and the containers for holding
raw and
bulk materials are clean, in good repair and in
sanitary condition.
加工，
周转和灌装
工具，
以及装原料和散装原料的容器要保持干净，
并维护良好和
在卫
生的状况下。
b.
Only approved
materials are used.
美国化妆品良好生产规范指南
5
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