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coke是什么意思美国FDA CGMP英汉对照版

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2021-01-19 11:54
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大白菜的英文-coke是什么意思

2021年1月19日发(作者:avocado)
美国
FDA

CGMP
英汉对照版

Subpart A-General Provisions

A
.总则

§

211.1 Scope

211

1
范围

a)

The
regulations
in
this
part
contain
the

a


本部分的条例包含人用
minimum current
good manufacturing practice

或兽用药品制备的现行
for
preparation
of
drug
products
for
最低限度的药品生产管
administration to humans or animals.

理规范(
GMP



b)

The
current
good
manufacturing
practice

regulations
in
this
chapter,
as
they
pertain
to

b


在本章里的这些针对药
drug products, and in parts 600 through 680 of
品的现行
GMP
条例和
this
chapter,
as
they
pertain
to
biological
本章
600

680
部分的
products for human use, shall be considered to
所有针对人用生物制品
supplement,
not
supersede
,
the
regulations
in
的现行
GMP
条例,
除非
this
part
unless
the
regulations
explicitly
明确另有说明外,应认
provide otherwise. In the event it is impossible
为是对本部分条例的补
to
comply
with
applicable regulations both
in
充,而不是代替。本章
this part and in other parts of this chapter or in
其他部分或本章
600

parts
600
through
680
of
this
chapter,
the
680g
各部分均可适用的
regulation
specifically
applicable
to
the
drug
条例,前部分的条例可
product
in
question
shall
supersede
the
以代替本部分条例。

regulation in this part.


c


在考虑经提议的,发表
c)

Pending
consideration
of
a
proposed


1978

9

29
日联
exemption
,
published
in
the
Federal
Register
邦注册表(
FR
)上一项
of
September
29,
1978,
the
requirements
in
免除时,若产品及其所
this
part
shall
not
be
enforced
for
OTC

drug
有成分是以人用物品形
products
if
the
products
and
all
their
式作一般销售和消费,
ingredients
are
ordinarily
marketed
and
且这些产品根据其预期
consumed
as
human
foods,
and
which
用途,亦可列入药品的
products
may
also
fall
within
the
legal
范围,则不应对这些非
definition of drugs
by virtue of
their intended
处方药(
OTC
)实施本
use. Therefore, until further notice, regulations
部分条例,直至进一步
under
part
110
of
this
chapter,
and
where
的通知为止。本章
110
applicable,
parts
113
to
129
of
this
chapter,
部分和
113

119
部分
shall
be
applied
in
determining
whether
these
的条例用于鉴别这些亦
OTC
drug
products
that
are
also
foods
are
是食品的
OTC
药品是
manufactured,
processed,
packed,
or
held
否按照
GMP
的要求生
under current good manufacturing practice.
产、
加工、
包装&贮存。

§

211.3 Definitions.
211

3
定义

The
definitions
set
forth
in
§
210.3
of
this
chapter



本章
211

3
中的定义使用
apply in this part.

于本部分。

good manufacturing practice (

GMP )

良好的生产管理规范

over-the-counter

OTC





人用非处方药



per`tain
适合,属于






expli`citly
明白地,确切地

super`sede
代替,取代,延期








ex`emption
解除,免除,免税


1
Subpart B-Organization and Personnel

§

211.22 Responsibilities of quality control unit.
a)

There shall be a quality control unit that shall
have
the
responsibility
and
authority

to
approve or reject all components, drug product
containers,
closures
,
in- process
materials
,
packaging
material,
labeling,
and
drug
products,
and
the
authority
to
review
production
records
to
assure
that
no
errors
have occurred or, if errors have occurred, that
they have been fully investigated. The quality
control unit shall be responsible for approving
or
rejecting
drug
products
manufactured,
processed,
packed,
or
held
under
contract
by
another company.

b)

Adequate
laboratory
facilities
for
the
testing
and
approval
(or
rejection)
of
components,
drug
product
containers,
closures,
packaging
materials,
in-process
materials,
and
drug
products
shall
be
available
to
the
quality
control unit.

c)

The
quality
control
unit
shall
have
the
responsibility
for
approving
or
rejecting
all
procedures
or
specifications
impacting
on
the
identity,
strength,

quality,
and
purity
of
the
drug product.

d)

The responsibilities and procedures applicable
to
the quality
control
unit shall be in
writing;
such written procedures shall be followed.

B
组织与人员


211

22
质量控制部门的指责


a


本部门有批准和拒收所
有成分、
药品包装 容器、
密封件、中间体、包装
材料、标签及药品的职
责与权力。复查生产记
录 的权力,保证不产生
差错,或若发生差错,
保证他们充分调查这些
差错。本部门负责根 据
合同,批准或拒收由其
他公司生产、加工、包
装或贮存的药品。



b











备、批准(或拒收)的
各种成分、药品容器、
密封件 、包装材料及药
品,质量控制部门室可
以获得的。




c


本部门由批准或驳回影
响药品的均一性、效价或含量、质量及纯度的
所有程序或规格标准的
职责。



d


适用于本部门的职责与
程序,应成文字材料,
并应遵循。

Au`thority

权威,威信,权力,授权
















closure

关闭,使终止,密封件

in-process materials

中间体


2
§

211.25 Personnel qualifications.
211

25
人员资格



(a)

Each
person
engaged
in
the
manufacture,
a)

每位从事药品生产、加
processing, packing, or holding of a drug product
工、包装或仓贮工作的
shall have
education, training, and
experience, or
人员,应接受培训、教
any combination
thereof
, to enable that person to
育及有实践经验,完成
perform
the
assigned
functions.
Training
shall
be
委派的各项职务。培训
in
the
particular
operations
that
the
employee
是按照现行
GMP
(包括
performs
and
in
current
good
manufacturing
本章的现行
GMP
条例
practice
(including
the
current
good
和这些条例要求
的成
manufacturing practice regulations in this chapter
文程序)中涉及雇员的
and
written
procedures
required
by
these
内容。邀请合格人员指
regulations)
as
they
relate
to
the
employee's
导,并连续多次培训,
functions. Training in
current good manufacturing








practice

shall
be
conducted
by
qualified
GMP

CGMP
)对他们
individuals
on
a
continuing
basis
and
with
的要求。

sufficient
frequency
to
assure
that
employees

remain
familiar
with
CGMP
requirements

applicable to them.


b)

负责监督药品的生产、
(b)

Each
person
responsible
for
supervising

the
加工、包装或仓贮工作
manufacture, processing, packing, or holding of a
的每一个人员,应受过
drug
product
shall
have
the
education,
training,
教育、培训及有经验,
and
experience,
or
any
combination
thereof,
to
完成委派的各项职务。
perform assigned functions in such a manner as to
以此作为提供药
品具
provide
assurance
that
the
drug
product
has
the
有安全性、均一性、效
safety, identity, strength, quality, and purity that it
价或含量、质量及纯度
purports
or is represented to possess.
的保证。



(c)

There
shall
be
an
adequate
number
of
qualified
c)

有足够量执行和
监督
personnel
to
perform
and
supervise
the
每种药品的生产
、加
manufacture,
processing,
packing,
or
holding
of
工、包装或仓贮的合格
each drug product.
人员。


thereof

在其中,关于

的,相关地

current good manufacturing practice


CGMP
)现行
GMP
supervise

监督,管理,指导

purports

声称
.


3
§

211.28 Personnel responsibilities.
211

28
人员职责

(a)

Personnel
engaged
in
the
manufacture,
a)

从事药品生产、加
processing,
packing,
or
holding
of
a
drug
工、包装或仓贮的
product shall wear clean clothing appropriate
人员,应穿着适合
for
the
duties
they
perform.
Protective
于其履行职责的清
apparel
,
such
as
head,
face,
hand,
and
arm
洁衣服,按需要,
coverings,
shall
be
worn
as
necessary
to
按头部、脸部、手
protect drug products from contamination.
部、臂部加外罩,
(b)

Personnel
shall practice
good
sanitation

and
防止药品受污染。

health habits.
b)

人员保持良好的个
(c)

Only
personnel
authorized
by
supervisory
人卫生和健康。

personnel
shall
enter
those
areas
of
the
c)








buildings
and
facilities
designated
as
许,其他人不能进
limited-access areas.
入限制入内的建筑
(d)

Any
person
shown
at
any
time
(either
by
物和设施。

medical
examination
or
supervisory
d)



人< br>,




observation)
to
have
an
apparent
illness
or

,






open
lesions
that
may
adversely
affect
the
有影响药品安全性
safety
or
quality
of
drug
products
shall
be
和质量的疾病或开
excluded
from
direct
contact
with




,



components,
drug
product
containers,
接触各种成分、药
closures,
in-process
materials,
and
drug
品容器、
包装设备、
products
until
the
condition
is
corrected
or
密封件、中间体
,

determined by competent medical personnel
至病愈或经医学鉴
not to
jeopardize
the safety or quality of drug
定认为对药品安全
products. All personnel shall be instructed to
性及质量无危害性
report
to
supervisory
personnel
any
health
为止.教育所有人
conditions
that
may
have
an
adverse
effect

,






on drug products.

对药品有不利影响

的健康情况.

§

211.34 Consultants.

Consultants
advising
on
the
manufacture,
211.34
顾问

processing,
packing,
or
holding
of
drug
products








shall
have
sufficient
education,
training,
and

,
应聘请顾问对药品生
experience, or any combination thereof, to advise on
产、加工、包装或仓贮提
the subject for which they are retained. Records shall
出建议
,
他们受过足够的
be
maintained
stating
the
name,
address,
and
教育
,
培训
,
且有丰富的实
qualifications
of
any
consultants
and
the
type
of
践经验
,
保留他们的姓名、
service they provide.

地址、任何的顾问资格及
服务形式等履历资料
.
Protective apparel

洁净服,保护服

sanitation


卫生,卫生设施,

jeopardize

危害


4
Subpart C-Buildings and Facilities
§

211.42 Design and construction features.


a


Any
building
or
buildings
used
in
the
manufacture, processing, packing, or holding of
a
drug
product
shall
be
of
suitable
size,
construction and location to facilitate cleaning,
maintenance, and proper operations.


b


Any
such
building
shall
have
adequate
space
for
the
orderly
placement
of
equipment
and
materials
to
prevent
mixups

between
different
components, drug product
containers,
closures,
labeling, in-process materials, or drug products,
and
to
prevent
contamination.
The
flow
of
components, drug product
containers,
closures,
labeling,
in-process
materials,
and
drug
products through the building or buildings shall
be designed to prevent contamination.


c


Operations
shall
be
performed
within
specifically
defined
areas
of
adequate
size.
There
shall
be
separate
or
defined
areas

or
such
other
control
systems
for
the
firm's
operations
as
are
necessary

to
prevent
contamination
or
mixups
during
the
course
of
the following procedures:
(1)

Receipt,

identification
,
storage,
and
withholding

from
use
of
components,
drug
product
containers,
closures,
and
labeling,
pending
the
appropriate
sampling,
testing,
or
examination by the
quality control
unit before
release for manufacturing or packaging;
(2)

Holding
rejected
components,
drug
product
containers,
closures,
and
labeling
before
disposition;

(3)

Storage of released components, drug product
containers, closures, and labeling;

(4)

Storage of in-process materials;

(5)

Manufacturing and processing operations;
(6)

Packaging and labeling operations;
(7)

Quarantine
storage
before
release
of
drug
products;
identification
辨别,证明

withholding

扣交

quality control

QC
)质量管理,质量控制

Quarantine

检疫,隔离


5
C
.厂房和设施

211

42
设计与建造特征


a






某类


生产、加工、包装或




房或


群,大小适宜,结构
与位置使其易清洁、
保养、适合操作。


b






足够






理地


设备和放 置材料,避
免不同类的成分、药
品容器、密封件、标
签、中间体或药品等
相< br>互


,防


染。通过厂房的上述



向在


时要防止污染。


c






明确


的,大小适中的地区
进行。这些地区按规
定各自格开,以防污
染 。下列操作须在单
独的地区内进行:

(1)

发放给生产或包装前 ,
质量控制部门取
样期
间,成分、药品容器、
密封件及标签的签收、
鉴别、贮存及拒收。

(2)

在处理前,拒收
的成
分、药品容器、密封件
及标签的贮存。

(3)

已发放的成分、药品容
器、密封件及标签的贮
存。

(4)

中间体的贮存。

(5)

生产与加工操作。

(6)

包装和贴标签操作。

(7)

药品发放前隔离贮存。


(8)

Storage of drug products after release;
(9)

Control and laboratory operations;
(10)

A
septic

processing,
which
includes
as
appropriate:

I


Floors,
walls,
and
ceilings
of
smooth,
hard
surfaces that are easily cleanable;
II


T
emperature and humidity controls;
III


An
air
supply
filtered
through
high- efficiency
particulate
air
filter
s
under
positive pressure, regardless of whether flow
is
laminar
or nonlaminar;
IV


A
system
for
monitoring
environmental
conditions;
V


A

system
for
cleaning
and
disinfecting

the
room
and
equipment
to
produce
aseptic
conditions;
VI


A
system
for
maintaining
any
equipment
used to control the aseptic conditions.


d


Operations
relating
to
the
manufacture,
processing,
and
packing
of
penicillin

shall
be
performed in facilities separate from those used
for other drug products for human use.
aseptic

无菌的,防腐剂



asepsis
无菌

filter
过滤器,滤过,渗入

laminar
层状或薄片状的,层流

disinfect
消毒


penicillin

青霉素(盘尼西林)

(8)

发放后药品的贮存。

(9)

控制与实验室操作。

(10)


菌操作及有关要求:


I


地板、墙壁和天花板平
滑、
坚硬、
表面易清洁;

II



温度与湿度控制;

III











器,在正压下过滤,层
流或非层流均可;

IV


环境检测系统;

V



创造无菌环境,房间
和设备的清洁、消毒系
统;

VI


控制无菌环境的设
备维修系统。




d


青霉素生产、加工
及包装设备与生产其
他人用药品的设备分
开。



6
§

211.44 Lighting.
Adequate lighting shall be provided in all areas.


§

211.46
Ventilation
,
air
filtration,
air
heating
and
cooling.


a


Adequate ventilation shall be provided.

b


Equipment
for
adequate
control
over
air
pressure,
micro-organisms
, dust, humidity, and
temperature shall be provided when appropriate
for
the
manufacture,
processing,
packing,
or
holding of a drug product.

c


Air
filtration
systems,
including
prefilters
and
particulate matter air filters, shall be used when
appropriate on air supplies to production areas.
If
air
is
recirculated

to
production
areas,
measures shall be taken to control recirculation
of
dust
from
production.
In
areas
where
air
contamination
occurs
during
production,
there
shall
be
adequate
exhaust
systems

or
other
systems adequate to control contaminants.

d


Air-handling
systems

for
the
manufacture,
processing,
and
packing
of
penicillin
shall
be
completely
separate
from
those
for
other
drug
products for human use.
211

44
照明

所有地区均须充足的照明。


211

46
通风、空气过滤、
空气加热与冷却


a


提供足够的通风。


b






控制


正压、
微生物、
尘土、
湿度和温度的设备,
适应药品生 产、加工
和贮存之需要。


c


空气过滤系统 ,包括




和微


质空气过滤器。 空气




送至


区,如果空气是循 环
到生产区,应测量尘
埃含量,控制从生产
区带来的尘埃。在生
产区,空气中 发生空
气污染,应用排气系




系统






,控


染。


d


青霉素生产、加工和



气输






他人






输送


完全分开。

ventilation
通风,流通空气

micro- organism
微生物


re`circulate


再通行
,
再流通

exhaust systems
排气系统

air-handling systems
空气输送系统


7
§

211.48 Plumbing.

(a)

Potable
water
shall
be
supplied
under
continuous
positive
pressure
in
a
plumbing
system
free
of
defects
that
could
contribute
contamination
to
any
drug
product.

Potable
water
shall meet the standards prescribed in the
Environmental
Protection
Agency's
Primary
Drinking
Water
Regulations
set
forth
in
40
CFR
part
141.
Water
not
meeting
such
standards shall not be permitted in the potable
water system.


(b)

Drains

shall
be
of
adequate
size
and,
where
connected directly to a sewer, shall be provided
with an air break or other mechanical device to
prevent
back-siphonage
.


[43
FR
45077,
Sept.
29,
1978,
as
amended
at
48
FR
11426,
Mar. 18, 1983]


§

211.50 Sewage and refuse.
Sewage
, trash, and other refuse in and from
the
building
and
immediate
premises
shall
be
disposed of in a safe and
sanitary
manner.


§
211.52 Washing and toilet facilities.
Adequate
washing
facilities
shall
be
provided, including hot and cold water, soap or
detergent,
air
dryers
or
single-service
towels
,
and
clean
toilet
facilities
easily
accessible
to
working areas.
potable water


饮用水

drain


排水沟,排水设备

back-siphonage


虹吸倒流

sewage

下水道
,
污水

sanitary

卫生的,清洁的,消毒的

sanitation.
环境卫生

single-service towels
专用毛巾

211

48
管件

(a)
在持续正压下,应在对药
品无污染管道系统内供应
饮用水。饮用水应 符合环
境保护机构制定的“基本








40CFR141
部分)
。不符
合该标准的水不 准进入水
系统。



(b)
排水设备应有足够的大小,
可直接连接排水管及安装
防止虹吸倒流的空气破坏










[43FR 45077

1978

9

29
日,
修正于
48FR 11426

1983

3

18

]

211
·
50
污水和废料

来自厂房和附近建筑物的
污水、垃圾及其他废料,
用安全、卫生的方法处理。


211
·
52
洗涤和洗设备


供< br>适
当的



备,包括热、冷水、肥皂、
清洁剂、空 气干燥器或专
用毛巾及易进入厕所的清
洁设备。


8
§

211.56 Sanitation.
a)

Any
building
used
in
the
manufacture,
processing,
packing,
or
holding
of
a
drug
product
shall
be
maintained
in
a
clean
and
sanitary condition, Any such building shall be
free
of
infestation

by
rodent
s,
birds,
insects,
and
other
vermin
(other
than
laboratory
animals). Trash and organic waste matter shall
be
held
and
disposed
of
in
a
timely
and
sanitary manner.
b)

There
shall
be
written
procedures
assigning
responsibility
for
sanitation
and
describing
in
sufficient
detail
the
cleaning
schedules,
methods, equipment, and materials to be used
in
cleaning
the
buildings
and
facilities;
such
written procedures shall be followed.
c)

There
shall
be
written
procedures
for
use
of
suitable
raticides
,
insecticides,
fungicides
,
fumigating agent
s, and cleaning and sanitizing
agents.
Such
written
procedures
shall
be
designed
to
prevent
the
contamination
of
equipment,
components,
drug
product
containers,
closures,
packaging,
labeling
materials,
or
drug
products
and
shall
be
followed.
Raticides,
insecticides,
and
fungicides
shall
not
be
used
unless
registered
and
used
in
accordance
with
the
Federal
Insecticide,
Fungicide,
and
Raticide
Act
(7
U.S.C. 135).

d)

Sanitation
procedures
shall
apply
to
work
performed
by
contractors

or
temporary
employees
as
well
as
work
performed
by
full-time employees during the ordinary course
of operations.


infestation
(害虫

盗贼)出没,横行

rodent

啮齿动物

raticide

杀鼠剂

insecticide
杀虫剂

fungicide

杀真菌剂

fumigating agent

熏蒸剂

contractor

合同工
,
承包人



9
211
·
56
环境卫生

a)

所有用作药品生产、加工、
包装及贮存的厂房应保持
清洁、卫 生的环境,且不
受啮齿动物、鸟类、昆虫
及其他害虫侵扰(实验动
物除外)
。 垃圾和有机废
料,及时以卫生的方法控
制与处理。


b)

填写分配卫生清洁任务和
详细的清洁项目、方法、
设备,用于清洁厂房和设
施 的材料的一览表。



c)

填写使用的杀鼠剂、杀昆< br>虫剂、杀真菌剂、薰蒸剂、
去垢剂和消毒剂一览表。
防止这些物品对设备、成
份 、药品容器、密封件、
包装材料、标签或药品污
染。除依据联邦杀虫剂、











7 U.S.C135
)已登记和使
用的品种外,其他的不用。





d)

在平常的操作过程中,环
境卫生工作应适于合同 工
或临时工及专职人员去完
成。

§

211.58 Maintenance.
Any
building
used
in
the
manufacture,
processing, packing, or holding of a drug product
shall
be
maintained
in
a
good
state
of
repair.
Subpart D-Equipment

§

211.63 Equipment design, size, and location.
Equipment
used
in
the
manufacture,
processing, packing, or holding of a drug product
shall be of appropriate design, adequate size, and
suitably
located
to
facilitate
operations
for
its
intended
use
and
for
its
cleaning
and
maintenance.


§

211.65 Equipment construction.

a


Equipment
shall
be
constructed
so
that
surfaces
that
contact
components,
in- process
materials,
or
drug
products
shall
not
be
reactive, additive, or absorptive so as to alter
the
safety, identity, strength, quality, or purity

of
the
drug
product
beyond
the
official
or
other established requirements.

b


Any
substances
required
for
operation,
such
as
lubricants
or
coolants
, shall not come into
contact
with
components,
drug
product
containers,
closures,
in-process
materials,
or
drug
products
so
as
to
alter
the
safety,
identity,
strength,
quality,
or
purity
of
the
drug
product
beyond
the
official
or
other
established requirements.

safety, identity, strength, quality, or purity


安全性、均一性、效价、

质量或

纯度

lubricant



滑润剂

coolants

冷冻剂,散热剂

211
·
58
保养

任何用于药品生产、加工、
包装或贮存的厂房应保持保
养良好状态。



211

63
设备的设计、尺寸
及位置

药品生产、加工、包装
或贮存设备,设计 合理,大
小适当,布置合理,便于操
作、清洁和保养。



211

65
设备制造

e)

设备表 面与各种成份、

间体或药品接触,
不产生
化学反应和吸附作用。

证药品的安全性、均一
性、
效价或含量、
质量或
纯度不变。


f)

操作所需之物质,
如润滑
剂、
冷却剂等不 能进入设
备里,
与成分,
药品容器、
封口物品、
中间体或药品
接触,保证药品的安全
性、
均一性、
效价或含量、
质量或纯度不变。


10
§

211.67 Equipment cleaning and maintenance.

a


Equipment
and
utensils

shall
be
cleaned,
maintained,
and
sanitized
at
appropriate
intervals

to
prevent
malfunctions
or
contamination
that
would
alter
the
safety,
identity,
strength,
quality,
or
purity
of
the
drug
product
beyond
the
official
or
other
established requirements.

b


Written
procedures
shall
be
established
and
followed
for
cleaning
and
maintenance
of
equipment,
including
utensils,
used
in
the
manufacture, processing, packing, or holding
of
a
drug
product.
These
procedures
shall
include, but are not necessarily limited to, the
following:
(1)

Assignment
of
responsibility
for
cleaning
and maintaining equipment;
(2)

Maintenance
and
cleaning
schedules,
including,
where
appropriate,
sanitizing
schedules;
(3)

A
description
in
sufficient
detail
of
the
methods,
equipment,
and
materials
used
in
cleaning
and
maintenance
operations,
and
the
methods
of
disassembling

and
reassembling

equipment
as
necessary
to
assure proper cleaning and maintenance;
(4)

Removal
or
obliteration
of
previous
batch
identification;
(5)

Protection
of
clean
equipment
from
contamination prior to use;
(6)

Inspection
of
equipment
for
cleanliness
immediately before use.
(7)

Records
shall
be
kept
of
maintenance,
cleaning,
sanitizing,
and
inspection
as
specified in §
§
211.180 and 211.182.



utensil


器具



interval

距离,时间间隔



disassemble
拆卸,分解



reassemble
重新组装,重新集合

211

67
设备清洁与保养

a)

相隔一定时间,
对设备与
工具进行清洁、
保养和消
毒,防止出故障与污染,< br>影响药品的安全性、
均一
性、
效价或含量、
质量或
纯度。

b)

制定药品生产、
加工、

装或贮存 设备(包括用
具)
的清洁和保养文字程
序,
并执行。
这种程序包括,
但不一定限于以下内
容:

1)









务。

2)









览表,包括消毒一览
表。

3)









和保养的设备、物品
和方法。拆卸和 装配
















的要求。

4)









留物的鉴定。

5)









洁设备的保护。

6)

使< br>用






设备。

(7)
保留保养、清洁、消
毒的记录。

211
·
180

211
·
182
的说明
检查。


11
§

211.68
Automatic,
mechanical,
and
electronic
equipment.

a


Automatic,
mechanical,
or
electronic
equipment
or
other
types
of
equipment,
including
computers,
or
related
systems
that
will perform a function satisfactorily, may be
used in the manufacture, processing, packing,
and
holding
of
a
drug
product.
If
such
equipment
is
so
used,
it
shall
be
routinely

calibrated
, inspected, or checked according to
a
written
program
designed
to
assure
proper
performance.
Written
records
of
those
calibration
checks
and
inspections
shall
be
maintained.

b


Appropriate
controls
shall
be
exercised
over
computer
or
related
systems
to
assure
that
changes
in
master
production
and
control
records or other records are instituted only by
authorized
personnel.
Input
to
and
output
from
the
computer
or
related
system
of
formulas
or
other
records
or
data
shall
be
checked
for
accuracy.

The
degree
and
frequency of input/output
verification
shall be
based on the complexity and reliability of the
computer or related system. A
backup
file of
data
entered
into
the
computer
or
related
system
shall
be
maintained
except
where
certain
data,
such
as
calculations
performed
in
connection
with
laboratory
analysis,
are
eliminated
by
computerization
or
other
automated
processes.
In
such
instances
a
written
record
of
the
program
shall
be
maintained along with
appropriate validation
data.
Hard
copy
or
alternative
systems,
such
as duplicates, tapes, or microfilm, designed to
assure
that
backup
data
are
exact
and
complete and that it is secure from alteration,
inadvertent
erasures,
or
loss
shall
be
maintained.


[43 FR 45077, Sept. 29, 1978,
as amended at 60 FR 4091, Jan. 20, 1995]

routinely

惯例地,例行公事地

calibrate

校准













verification
确认,查证

backup

备份,侯补


12
211

68
自动化设备、机械
化设备和电子设备


a

< br>用于药品生产、加工、







化、机械化或电子设
备,包括计算机或其
他类型设备。按惯例,
对其设 计之成文条款
作校准、检查或核对,








好。保留检查、标定、
核对等文字记录。


b


对保障重要生产变化
的计算机或有关系统
进行操作培训。操作
记录或其他记录只能








订。向计算机或有关
系统输入或从中输出
的各种方案、其他 记
录或资料,应核查其
准确性。输入计算机
或有关系统内的档案
资料,除与实 验室共
同分析计算的结果可
消除外,其他的应保
留。文字记录与相应








存。事先设计好的硬
件 复制品或多种选择
系统,如复印件、磁
带或微型胶卷等,保
证其支持资料正确、
可靠及完整。出现资
料改动、非人为消除
或遗失时,
应维修。
[43
FR
45077,
Sept.
29,
1978,
as
amended
at
60
FR
4091,
Jan.
20,
1995]
§

211.72 Filters
Filters
for
liquid
filtration
used
in
the
manufacture,
processing,
or
packing
of
injectable

drug
products
intended
for
human
use
shall
not
release
fibers
into
such
products.
Fiber- releasing
filters
may
not
be
used
in
the
manufacture,
processing,
or
packing
of
these
injectable
drug
products
unless
it
is
not
possible
to
manufacture
such drug products without the use of such filters.
If
use
of
a
fiber-releasing
filter
is
necessary,
an
additional non-fiber- releasing filter of 0.22 micron
maximum
mean
porosity

(0.45
micron
if
the
manufacturing
conditions
so
dictate)
shall
subsequently
be
used
to
reduce
the
content
of
particles in the injectable drug product. Use of an
asbestos
-
containing
filter
,
with
or
without
subsequent
use
of
a
specific
non-fiber-releasing
filter, is permissible only upon submission of proof
to
the
appropriate
bureau
of
the
Food
and
Drug
Administration
that
use
of
a
non-fiber-releasing
filter will, or is likely to, compromise the safety or
effectiveness of the injectable drug product.


Subpart
E-Control
of
Components
and
Drug
Product Containers and Closures


§

211.80 General requirements.


a


There
shall
be
written
procedures
describing
in
sufficient
detail
the
receipt,
identification,
storage,
handling,
sampling,
testing,
and
approval or rejection of components and drug
product containers and closures; such written
procedures shall be followed.

b


Components and drug product containers and
closures
shall
at
all
times
be
handled
and
stored in a manner to prevent contamination.

c


Bagged or boxed components of drug product
containers, or closures shall be stored off the
floor
and
suitably
spaced
to
permit
cleaning
and inspection.





injectable


血管注射剂,可注射的






porosity


孔径,多孔性
,
有孔性






asbestos-containing filter

含石棉过滤器

211

72
过滤器

用于生产、
加工的液体过
滤器或人用注射药品的包装
材料不许释放出纤维物进入
产品。除必不得以,不在生
产、加工中使用释放纤维物
的 过滤器或注射药品的包装
材料。若必须使用一种能释
放纤维物的过滤器,最后应
使用一 非释放纤维物、平均
最大孔径为
0.22
微米
(如实
际生产条件限制 ,可用
0.45
微米)的附加过滤器过滤,
降低注射剂内微粒量。使用
含石棉 的过滤器,最后用或
不用特殊非释放纤维过滤器
均可以,
但要根据
FDA有关
部门提供的,关于该非释放
纤维过滤器会或可能损害注
射剂的安全性和有效性 的证
据而定。


E.
成分、药品容器和密封件
的控制


211

80
总要求


a










分、药品容器、密封
件的签收、鉴定、贮存、装运、取样、检
验和批准或拒收等程
序,并遵循。


b


成份、药品容器和密
封件应专人管理和在
防污染环境下贮存。


c


药品容器的包装袋、
包装箱或密封件应离
地面放置,保持适当
间隔,便于清洁检查。


13

d


Each container or
grouping of containers for
components
or
drug
product
containers,
or
closures shall be identified with a distinctive
code for each lot in
each shipment
received.
This
code
shall
be
used
in
recording
the
disposition
of
each
lot.
Each
lot
shall
be
appropriately
identified
as
to
its
status
(i.e.,
quarantined
, approved, or rejected).

§

211.82
Receipt
and
storage
of
untested
components, drug product containers, and closures.


a


Upon
receipt
and
before
acceptance,
each
container
or
grouping
of
containers
of
components,
drug
product
containers,
and
closures
shall
be
examined
visually
for
appropriate labeling as to contents, container
damage or broken seals, and contamination.

b


Components,
drug
product
containers,
and
closures shall be stored under quarantine until
they
have
been
tested
or
examined,
as
appropriate,
and
released.

Storage
within
the area shall conform to the requirements of
§
211.80.

§

211.84
Testing
and
approval
or
rejection
of
components, drug product containers, and closures.



a


Each
lot
of
components,
drug
product
containers,
and
closures
shall
be
withheld

from
use
until
the
lot
has
been
sampled,
tested,
or
examined,
as
appropriate,
and
released for use by the quality control unit.


d


用明显的已接收的装
货量中的批号代码对
成份、药品容器或密
封件加以鉴别。此代
码用来记录每批货的
放置地方。对每批货的情况,如隔离、批
准或拒收等作检查。


211

82
未检验的成份、药
品容器和密封件的接收与贮


a)
< br>接收时和验收前,对








容器、药品容器和密
封件进行目检,给内
容物、容器损坏或拆








适当的标志。

b)

成分、药品容器和密
封件应隔离贮存,直








格,可发放。在符合
211
·

80
要求的地区
中贮存。

211

84
成分、药品容器和
封口物品的试验、批准或拒



a


每批成份、药品容器
和封口物品,在未经
质量控质部门取样、
检查合格前,不准使
用。检验合格后发放
使用。

quarantine

检疫
,
隔离
, (
政治或商业上的
)
封锁
,
withhold

禁止,拒给,保留


14

b


Representative
samples
of
each
shipment
of

b


收集每批的每一装货
each
lot
shall
be
collected
for
testing
or
量的代表性样品,供
examination. The number of containers to be
检验用。

sampled,
and
the
amount
of
material
to
be
容器的取样数目和每
taken
from
each
container,
shall
be
based
一容器里物质的取样
upon
appropriate
criteria

such
as
statistical < br>量







criteri a for component variability, confidence
的,例如,成份的变
levels,
and
degree
of
precision
desired,
the
异性统计学标准、可
past
quality
history
of
the
supplier,
and
the
信限、要求的精密度、
quantity
needed
for
analysis
and
reserve
供应商过去的质量历
where required by §
211.170. < br>史、
211
·
170
要求分
析和留样所需的数量
(< br>c


Samples shall be collected in accordance with
the following procedures:
等。

(1)

The containers of components selected shall

c


收集样品程序:

be cleaned where necessary, by appropriate

1


用适当的方法,
means.







(2)

The
containers
shall
be
opened,
sampled,
器。

and
resealed
in
a
manner
designed
to

2


打开容器,取样,
prevent contamination of their contents and
重新封口,防止其
contamination
of
other
components,
drug
内容物受污染和其
product containers, or closures.
他成份、药品容器
(3)

Sterile
equipment

and
aseptic
sampling
或密封件的污染。

techniques shall be used when necessary.

3


必要时,
使用灭菌
(4)

If
it
is
necessary
to
sample
a
component
设备和无菌取样技
from
the
top,
middle,
and
bottom
of
its
术。

container,
such
sample
subdivisions
shall

4


如果需要从容器
not be
composited
for testing.
顶部、中部和底部
(5)

Sample containers shall be identified so that
的成份中取样,样
the
following
information
can
be
品须混合。

determined:
name
of
the
material
sampled,

5


鉴定样品容器,

the
lot
number,
the
container
from
which







the sample was taken, the date on which the
料:被取样的材料
sample
was
taken,
and
the
name
of
the
名称、批号、被取
person who collected the sample.
样的容器,取样日
(6)

Containers
from
which
samples
have
been
期及样品收集人的
taken shall be marked to show that samples
名字等。

have been removed from them.

6


已取样的容器,

作标志,表示样品
已去处。

criteri

标准

sterile equipment
灭菌设备

composite
混合,复合,合成物


15

d


Samples
shall
be
examined
and
tested
as

d


样品检验程序:

follows:


1)









(1)

At least one test shall be conducted to verify
份,最少做一个特性
the
identity
of
each
component
of
a
drug
试验。如有专一的特
product. Specific identity tests, if they exist,
性实验就应采用。

shall be used.
2)









(2)

Each
component
shall
be
tested
for








confor mity
with
all
appropriate
written
份的纯度、含量和质
specifications
for
purity,
strength,
and
量。生产厂家代替上
quality.
In
lieu
of

such
testing
by
the
述试验,规定生产厂
manufacturer,
a
report
of
analysis
may
be








accepted from the supplier of a component,
特别特性试验,可承
provided
that
at
least
one
specific
identity








test is conducted on such component by the








manufacturer,
and
provided
that
the







manufacturer
establishes
the
reliability
of
间,生产厂家定期验
the
supplier's
analyses
through
appropriate







validation
of
the
supplier's
test
results
at
果,证明供应者的分
appropriate intervals.

析结果是准确的。

(3)

Containers
and
closures
shall
be
tested
for
3)

依照成文规程,检验
conformance
with
all
appropriate
written
容器和密封件。生产
procedures.
In
lieu
of
such
testing
by
the
厂家代替上述试验,
manufacturer, a
certificate
of testing may be







accepted from the supplier, provided that at
些容器或封口物品,
least a visual identification is conducted on
最少做一次目检。可
such
containers/closures
by
the








manufacturer
and
provided
that
the
证明书。规定生产厂
manufacturer
establishes
the
reliability
of








the
supplier's
test
results
through
的试验结果,证明其
appropriate
validation
of
the
supplier's
test
试验结果是正确的。

results at appropriate intervals.
4)

必要时,用显微镜检
(4)

When
appropriate,
components
shall
be
测成份。

microscopically
examined.
5)

每批易受污物、昆虫
(5)

Each
lot
of
a
component,
drug
product








container,
or
closure
that
is
liable
to
染的某一成份、药品
contamination
with
filth,
insect
infestation,
容器或密封件,应按
or
other
extraneous
adulterant

shall
be








examined
against
established
specifications








for such contamination.
染。




in lieu of


代替




certificate

证书,发证书给





microscopically

显微镜检地,精细地




adulterant
掺杂物


16
(6)

Each
lot
of
a
component,
drug
product
container,
or
closure
that
is
liable
to
microbiological
contamination
that
is
objectionable
in
view
of
its
intended
use
shall
be
subjected
to
microbiological
tests
before use.

e


Any
lot
of
components,
drug
product
containers,
or
closures
that
meets
the
appropriate
written
specifications
of
identity,
strength,
quality,
and
purity
and
related
tests
under
paragraph
(d)
of
this
section
may
be
approved
and
released
for
use.
Any
lot
of
such
material
that
does
not
meet
such
specifications
shall
be
rejected.

[43
FR
45077, Sept. 29, 1978, as amended at 63 FR
14356, Mar. 25, 1998]

§

211.86
Use
of
approved
components,
drug
product containers, and closures.

Components,
drug
product
containers,
and
closures
approved
for
use
shall
be
rotated
so
that
the
oldest
approved
stock
is
used
first.
Deviation
from
this
requirement
is
permitted
if
such
deviation is temporary and appropriate.

§

211.87 Retesting of
approved components,
drug
product containers, and closures.



Components,
drug
product
containers,
and
closures
shall
be
retested
or
reexamined,
as
appropriate,
for
identity,
strength,
quality,
and
purity
and
approved
or
rejected
by
the
quality
control
unit
in
accordance
with
§
211.84
as
necessary,
e.g.,
after
storage
for
long
periods
or
after exposure to air, heat
or other conditions that
might
adversely
affect
the
component,
drug
product container, or closure.


§

211.89
Rejected
components,
drug
product
containers, and closures.
Rejected
components,
drug
product
containers,
and
closures
shall
be
identified
and
controlled
under
a
quarantine
system
designed
to
prevent
their
use
in
manufacturing
or
processing
operations for which they are unsuitable.


17
6)








染,产伤不良效果的
某易成份、药品容器
或密封件,鉴于 其预
期用途,在使用前,
应做微生物试验。



e


任何批号的成份、药
品容器或密封件,若








性、效价或含量、质< br>量、纯度等的规格标
准和本部分()的有
关试验,可批准使用。

何< br>批





料,不符合这些规格,
应拒收 。


211.86
获准的成份、药品容
器和密封件的使用

已获准作用的成份、
品容器和密封件,先入库
者先用。若产生的偏差是
暂时的和适当的,这种偏
差是容 许的。


211.87
获准的成份、药品容
器&密封件的复检

经质量控制部门批准或
拒收 的成份、药品容器&
密封件,若长期贮存或曝
露在空气、热或其他可能
对其产生不良影 响的环境
后,应依照
211.84
,对均
一性、效价或含量、质量、
纯度等复检。


211.89
拒收的成份、药品容
器&封口物品

拒收的成份、药品容器
&封口物 品应经鉴定和在
隔离系统下加以控制,防
止在生产&加工中使用。

§

211.94 Drug product containers and closures.
211.94
药品密容器和密封件

a)

药品包装容器&密封

a


Drug
product
containers
and
closures
shall
not
be
reactive,
additive,
or
absorptive
so
as
件应不起反应、不吸
to
alter
the
safety,
identity,
strength,
quality,
着、不吸附、不致改
or
purity
of
the
drug
beyond
the
official
or
变药品的安全性、均
established requirements.
一性、 含量或效价、









b


Container
closure
systems
shall
provide
adequate
protection
against
foreseeable







external
factors
in
storage
and
use
that
can
的规定的规定要求。

cause
deterioration
or
contamination
of
the
b)









drug product.




使


程< br>中








(< br>c


Drug product containers and closures shall be
clean
and,
where
indicated
by
the
nature
of








the
drug,
sterilized
and
processed
to
remove







pyrogenic
properties

to
assure
that
they
are
防护。

suitable for their intended use.
c)








应清洁、灭菌和除 热

d


Standards
or
specifications,
methods
of
testing,
and,
where
indicated,
methods
of
原,保证其适用于预
cleaning,
sterilizing,
and
processing
to
期目的。

remove pyrogenic properties shall be written
d)









and followed for drug product containers and
的标准或规格、检验
closures.

方法(指清洁和消毒

方法、除热原过程)
应成文并遵循。

Subpart F-Production and Process Controls

§

211.100 Written procedures;
deviations
.
F.
生产和加工控制


a


There
shall
be
written
procedures
for
211.100
成文的规程,偏差

production
and
process
control
designed
to

a










assure
that
the
drug
products
have
the
均一性、
含量或效价、

identity,
strength,
quality,
and
purity
they
量及纯度而设计的生产
purport
or
are
represented
to
possess.
Such
和加工控制程序,
这些程
procedures
shall
include
all
requirements
in
序包括本部内全部要求。
this
subpart.
These
written
procedures,
这些成文程序
(包括任何
including
any
changes,
shall
be
drafted,
变化)须经有关部门起
reviewed,
and
approved
by
the
appropriate
草、
复查和批准,
然后再
organizational
units
and
reviewed
and
经质量控制部门复查与
approved by the quality control unit.
批准。


b


Written
production
and
process
control

b










procedures shall be followed in the execution
加工控制功能中,
遵循已
of the various production and process control
制定的生产和加工控制
functions and shall be documented at the time
程序,
并在执行时以文件
of
performance.
Any
deviation
from
the
加以证明。
程序中出现的
written
procedures
shall
be
recorded
and
任何偏差,
应作记录,

justified.

提出证据。

pyrogenic property

热源












deviation


偏差,背离


18
§

211.101
Charge-in
of components.
Written production and control procedures
shall include the following, which are designed to
assure
that
the
drug
products
produced
have
the
identity,
strength,
quality,
and
purity
they
purport
or are represented to possess:

a


The batch shall be formulated with the intent
to
provide
not
less
than
100
percent
of
the
labeled
or
established
amount
of
active
ingredient.

b


Components
for
drug
product
manufacturing
shall be weighed, measured, or subdivided as
appropriate. If a component is removed from
the
original
container
to
another,
the
new
container
shall
be
identified
with
the
following information:
(1)

Component name or item code;
(2)

Receiving or control number;
(3)

Weight or measure in new container;
(4)

Batch for which component was dispensed,
including its product name, strength, and lot
number.

c


Weighing,
measuring,
or
subdividing
operations
for
components
shall
be
adequately
supervised.
Each
container
of
component
dispensed
to
manufacturing
shall
be
examined
by
a
second
person
to
assure
that:
(1)

The component was released by the quality
control unit;

(2)

The
weight
or
measure
is
correct
as
stated
in the batch production records;
(3)

The containers are properly identified.


d


Each
component
shall
be
added
to
the
batch
by
one
person
and
verified
by
a
second
person.


211.101
成份的进料

成文的生产&控制程< br>序包括下面的内容,其设计
应保证所生产的药品具有本
品原有的均一性、含量和效
价、质量和纯度。


a


按处方配制的药品,
保证其活性成份含量
不低于
100
%标示量
或规定量。


b


生产药品用的成份应
称量、测量或适当粉
碎。若一种成份从原
来容器转移到另一容
器内,用下列资料以
鉴别:


1










码。


2


接收或控制号。


3










或份量。


4


使






一批药品,包含其产
品名称含量和批号。


c


成份的称重、称量或
粉碎操作,应受到严
密的监督。所盛成份
已用于生产的每一容
器,须经第二人检查,
保证:


1










制人员发放的。


2


重量或份量正确,与
批生产记录一致。


3


容器经严格鉴别。



d


每一成份投料时,一
人操作,领一人核对。

charge-in

进料


19
§

211.103 Calculation of
yield
.
Actual
yields
and
percentages
of
theoretical
yield shall be determined
at the conclusion of
each
appropriate
phase
of
manufacturing,
processing,
packaging,
or
holding
of
the
drug
product.
Such
calculations shall be performed by one person and
independently verified by a second person.


§

211.105 Equipment identification.

a


All
compounding
and
storage
containers,
processing
lines,
and
major
equipment
used
during
the
production
of
a
batch
of
a
drug
product
shall
be
properly
identified
at
all
times
to
indicate
their
contents
and,
when
necessary,
the
phase
of
processing
of
the
batch.



b


Major
equipment
shall
be
identified
by
a
distinctive identification number or code that
shall
be
recorded
in
the
batch
production
record to show the specific equipment used in
the
manufacture
of
each
batch
of
a
drug
product.
In
cases
where
only
one
of
a
particular
type
of
equipment
exists
in
a
manufacturing
facility,
the
name
of
the
equipment may be used in lieu of a distinctive
identification number or code.

yield

产量,收益

at the conclusion of


……
.
完结时

211.103
产量计算

在药品生产、加工或
贮存的每一适当阶 段结束
时,测算实际产量与理论产
量的百分比。此计算由一人
进行,另一人单独核对。


211.105
设备鉴别


a


在整个生产周期内,
同批药品生产使用的








器、生产线和主要设< br>备应严格识别,标示
出药品的成份,需要
时,还须标出所处的
加工阶段。



b


一种药品每批生产使
用的主要设备 ,易鉴
别性识别或代号加以
识别。此鉴别号或代
号记录在该批产品的
记录上。 若生产中只
使用一种特殊型号的
设备,可用该设备名
字代替鉴别性识别号
或代 号。


20
(d)

Rejected
in-process
materials
shall
be
identified
and
controlled
under
a
quarantine
system
designed
to
prevent
their
use
in
manufacturing
or
processing
operations
for
which they are unsuitable.

§

211.111 Time limitations on production.
When
appropriate,
time
limits
for
the
completion
of
each
phase
of
production
shall
be
established
to
assure
the
quality
of
the
drug
product.
Deviation
from
established
time
limits
may
be
acceptable
if
such
deviation
does
not
compromise
the quality of the drug product. Such
deviation shall be justified and documented.


§

211.113
Control
of
microbiological
contamination.
a)

Appropriate
written
procedures,
designed
to
prevent
objectionable
microorganisms
in
drug
products
not
required
to
be
sterile
,
shall
be
established and followed.
b)

Appropriate
written
procedures,
designed
to
prevent
microbiological
contamination
of
drug
products
purporting
to
be
sterile,
shall
be
established and followed. Such procedures shall
include validation of any
sterilization
process.


§

211.115 Reprocessing.
Written
procedures
shall
be
established
and
followed
prescribing
a
system
for
reprocessing
batches
that
do
not
conform
to
standards
or
specifications and the steps to be taken to insure
that
the
reprocessed
batches
will
conform
with
all
established
standards,
specifications,
and
characteristics.
Reprocessing

shall
not
be
performed
without
the
review
and
approval
of
the
quality
control unit.

compromise

损害
……
的利益,妥协,折中

sterile

消过毒的

sterilization

消毒,杀菌,绝育

reprocessing

回收,再生,返工

(d)

不合格的中间体,在隔
离系 统下鉴别及控制,
防止其在生产或加工
操作中使用。



211.111
生产时间限制

在适当时候,制定完成










制,保证药 品质量。制定
的时间限制产生偏差,如










量,是可以接受的。这些
偏差应有文字文件证明 是
正当的。


211.113
微生物污染的控制


a


制订和遵循预防不需
消毒药品带有害微生
物的适当程序。


b


制订和遵循预防已消
毒药品微生物污染的
适当程序。这些程序
包括所有消毒过程的
验证。




211.115
返工

(a)

制订和遵循指导不合
格批号返工及保证返
工批号达标的程序。

(b)

没有质量控制部门复
检与批准
,
不许进行返
工。


21
Subpart G-Packaging and Labeling Control

§

211.122
Materials
examination
and
usage
criteria.

a


There
shall
be
written
procedures
describing
in
sufficient
detail
the
receipt,
identification,
storage,
handling,
sampling,
examination,
and/or
testing
of
labeling
and
packaging
materials;
such
written
procedures
shall
be
followed.
Labeling
and
packaging
materials
shall
be
representatively
sampled,
and
examined
or
tested
upon
receipt
and
before
use
in
packaging
or
labeling
of
a
drug
product.


b


Any labeling or packaging materials meeting
appropriate
written
specifications
may
be
approved
and
released
for
use.
Any
labeling
or packaging materials that do not meet such
specifications
shall
be
rejected
to
prevent
their
use
in
operations
for
which
they
are
unsuitable.

c


Records
shall
be
maintained
for
each
shipment
received
of
each
different
labeling
and
packaging
material
indicating
receipt,
examination or testing, and whether accepted
or rejected.

d


Labels
and
other
labeling
materials
for
each
different drug product, strength, dosage form,
or
quantity
of
contents
shall
be
stored
separately with suitable identification. Access
to
the
storage
area
shall
be
limited
to
authorized personnel.

e


Obsolete

and
outdated
labels,
labeling,
and
other packaging materials shall be destroyed.


f


Use of
gang printing
of labeling for different
drug
products
or
different
strengths
or
net
contents
of
the
same
drug
product,
is
prohibited
unless
the
labeling
from
gang-printed
sheets
is
adequately
differentiated by size, shape, or color.
obsolete

过时的,陈旧荒废的

gang printing

排字印刷

G
、包装和标签控制

211

122
材料的检查和使用
标准

a)

制订详述标签和包装材料
的接收、鉴别、贮存、装
卸、
取样检验的程序,

遵循这些成文程序。
在接
收、
用于药品包装和 贴标
签前,
有代表地对其取样
与检验。

b)

符 合成文规格标准的标签
和包装材料,
可批准发放
使用。
不符合规格者,

得用于生产。

c)

接收每批不同的标签和包
装材料 ,
均须签收、
测试。
无论是接收或拒收,
须保
留其记录。

d)

用于不同药品、含量、剂
型及成份数量的标签和
标示材料分别 贮存,
并挂
上适当牌证,
仅限经核准
人员接近贮存地区。

e)

作废和陈旧的标签、标示
材料及其他包装材料应
销毁。

f)

排字印刷在不同药品或同
一药品不同规格的品种
上使用的标签
(或大小相
同和同一或相似版式和
/
或彩色设计图标签)
应使
其缩到最小。
若使用排字
印刷,
考虑在印刷期间和
印刷后,印刷品的设置、
堆放、
切裁和管理等;

制订包装和标签工作专
门控制程序。


22

g


Printing
devices
on,
or
associated
with,
g)











manufacturing
lines
used
to
imprint
labeling
线,
其上的或与其有关的
upon the drug product unit label or case shall
印刷设备应受到监控,

be
monitored
to
assure
that
all
imprinting
证所有印痕与本批产品
conforms
to
the
print
specified
in
the
batch
记录中说明的印痕一致。

production
record.
[43
FR
45077,
Sept.
29,
[43
FR
45077,
Sept.
29,
1978,
as
amended
at
58
FR
41353,
Aug.
3,
1978,
as
amended
at
58
1993]

FR 41353, Aug. 3, 1993]
§

211.125 Labeling issuance.

211

125
标签的发放

a)

严格控制已发放的,

a


Strict control shall be exercised over labeling
issued
for
use
in
drug
product
labeling
用于药品的标签。

operations.

b)









材料,须认真检查其

b


Labeling materials issued for a batch shall be
carefully
examined
for
identity
and
均一性,应与一批或
conformity
to
the
labeling
specified
in
the








master or batch production records.
明的标签一致。




c


Procedures
shall
be
utilized
to
reconcile
the
quantities
of
labeling
issued,
used,
and
c)

核对发放的,已使用
returned,
and
shall
require
evaluation
of
的及回收的标签,若
discrepancies

found
between
the
quantity
of








drug
product
finished
and
the
quantity
of
出的标签数量不符,
labeling
issued
when
such
discrepancies
are







outside
narrow
preset
limits
based
on








historical operating data


Such discrepancies
量范围,则需对这些
shall
be
investigated
in
accordance
with
§

偏差做出评估。按照
211.192.
Labeling
reconciliation
is
waived
211.192
要求调查原
for
cut
or
roll
labeling
if
a
100-percent
因。

examination for correct labeling is performed

in accordance with §
211.122(g)(2).
d)









制号的标签,全部应

d


All
excess
labeling
bearing
lot
or
control
numbers shall be destroyed.

销毁。


e


Returned
labeling
shall
be
maintained
and

stored
in
a
manner
to
prevent
mixups
and
e)

回收的标签,如保留
provide proper identification.








存,防止混淆。


f


Procedures
shall
be
written
describing
in
sufficient
detail
the
control
procedures

employed
for
the
issuance
of
labeling;
such
f)



发< br>放




written procedures shall be followed. [43 FR








45077, Sept. 29, 1978, as amended at 58 FR
循。

41345, Aug. 3, 1993]

discrepancy

相差,矛盾,差异


23
§

211.130 Packaging and labeling operations.

There shall be written procedures designed to
assure that correct labels, labeling, and packaging
materials are used for drug products; such written
procedures
shall
be
followed.
These
procedures
shall incorporate the following features:


a


Prevention
of
mixups
and
cross-contamination

by
physical
or
spatial
separation
from
operations
on
other
drug
products.


b


Identification
and
handling
of
filled
drug
product containers that are set aside and held
in
unlabeled
condition
for
future
labeling
operations
to
preclude
mislabeling
of
individual containers, lots, or portions of lots.
Identification
need
not
be
applied
to
each
individual container but shall be sufficient to
determine
name,
strength,
quantity
of
contents,
and
lot
or
control
number
of
each
container.

c


Identification of the drug product with a lot or
control number that permits determination of
the history of the manufacture and control of
the batch.


d


Examination
of
packaging
and
labeling
materials
for
suitability
and
correctness
before
packaging
operations,
and
documentation
of
such
examination
in
the
batch production record.


e


Inspection
of
the
packaging
and
labeling
facilities
immediately
before
use
to
assure
that
all
drug
products
have
been
removed
from
previous
operations.
Inspection
shall
also
be
made
to
assure
that
packaging
and
labeling materials not suitable for subsequent
operations
have
been
removed.
Results
of
inspection
shall
be
documented
in
the
batch
production
records.[43
FR
45077,
Sept.
29,
1978,
as
amended
at
58
FR
41354,
Aug.
3,
1993]
cross-contamination

交叉感染

211

130
包装和标签操作
设计保证标签、标示及
包装材料正确用于药品的程
序,并遵循。这些程序结合
下列 特点:



a


预防混合和由物理的
或其他操作空间物质
引起的交叉感染。


b




c


带批号或控制号药品
的鉴别,允许检查该
批药品的制造和控制
历史。





d


包装工作开展前,检查包装和标签材料的
适用性和正确性,且
这些检验所提供的证
明文件应符合批生产
记录。





e


使用前,立即检查包
装和贴标签设备,保
证所有药品离开先前
的操作,同时移开不< br>适用于随后操作的包
装和标签材料。检查
结果以批生产记录形
式提供证明文件。







24
§

211.132
Tamper-evident
packaging requirements
for over-the-counter (OTC) human drug products.

a


General.
The
Food
and
Drug
Administration

has
the
authority
under
the
Federal
Food,
Drug, and
Cosmetic Act
(the act) to establish
a
uniform
national
requirement
for
tamper-evident
packaging
of
OTC
drug
products
that
will
improve
the
security
of
OTC
drug
packaging
and
help
assure
the
safety
and
effectiveness
of
OTC
drug
products.
An
OTC
drug
product
(except
a
dermatological, dentifrice, insulin, or lozenge

product) for retail sale that is not packaged in
a
tamper- resistant
package
or
that
is
not
properly
labeled
under
this
section
is
adulterated
under
section
501
of
the
act
or
misbranded
under
section
502
of
the
act,
or
both.

b


Requirement for tamper-evident package.

(1)

Each
manufacturer
and
packer
who
packages
an
OTC
drug
product
(except
a
dermatological,
dentifrice,
insulin,
or
lozenge
product)
for
retail
sale
shall
package
the
product
in
a
tamper-evident
package, if this product is accessible to the
public while held for sale. A tamper-evident
package
is
one
having
one
or
more
indicators
or
barriers
to
entry
which,
if
breached
or
missing,
can
reasonably
be
expected
to
provide
visible
evidence
to
consumers that tampering has occurred. To
reduce
the
likelihood
of
successful
tampering
and
to
increase
the
likelihood
that
consumers
will
discover
if
a
product
has
been
tampered
with,
the
package
is
required
to
be
distinctive
by
design
or
by
the use of one or more indicators or barriers
to
entry
that
employ
an
identifying
characteristic
(e.g.,
a
pattern,
name,
registered
trademark
,

logo
,
or
picture).
For
purposes
of
this
section,
the
term

cannot
be
duplicated
with
commonly
available
materials
or
through
commonly

25
21 1

132






OTC
)保险包装的要求


a


一般来说 ,在联邦食
品、药物和化妆品法
规下,
FDA
有权制定
非处方药保险 包装的
统一国家要求。提高
非处方药包装的可靠
性和有助保证非处方
药的安全 与效果。一
种零售
OTC
药品(皮
肤科药、牙粉、胰岛
素、喉片除外 )没有
包装在保险包装内或
没有适当的标签,根
据上述联邦法规
501
部分,属掺假药;根

502
部分或两者,
属错贴标签。


b


保险包装的要求,

(1)
< br>每







者,应将零售< br>OTC

品装入保险包装内,

此药易受公众影响,

药应在内保存至售出。

保险包装是内有一个
或多个指示物或障碍
物的药品 包装。
若缺损
或失落,
能适当地给顾
客提供已发生破损的
明显证据。
如果因缺损
而使产品受损,
则要求
包装在设计上应有特
色(例如喷雾 产品容
器)
或使用一个或多个
有鉴别性的指示物或
障碍物加进包装内
(例
如图案、名称、注册商
标、标识或图画等)

上述“在设计上有特
色”之意,即此包装不
能用一般的通用材料
和加工工艺来复制。

语“喷雾 产品”即用液

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