hosesICHQ中英文对照

料药会符合其预期的质量与纯度要

求所 必需的活动。

所有涉及质量管理

的活动都应当明确规定，

并使其文件

化。

activities should be defined and

documented.

2.13

There should be a quality

2.13

应当设立一个独立于生产部门

unit(s)

that

is

independent

of

production

and

that

fulfills

both

quality

assurance

(

QA

)

and

quality

control

(

QC)

responsibilities.

The

quality

unit

can

be

in

the

form

of

separate

QA

and

QC

units

or

a

single

individual

or

group,

depending

upon

the

size

and

structure of the organization.

2.14

The

persons

authorized

to

release

intermediates

and

APIs

should be specified.

2.15

All

quality-related

activities should be recorded at

的质量部门，

同时履行质量保证

(

QA

)

(

QC

)< /p>

的职责。依照组织

机构的大小，

可以是分 开的

QA

和

QC

部门，或者只是一个人或小组。

2.14

应当指定授权发放中间体和 原

料药的人员。

2.15

所有有关质量的活动应当在其

the time they are performed.

执行时就记录。

2.16

Any

deviation

from

2.16

任何偏离既定规程的情况都应

established

procedures

should

be

当有文字记录并加以解释。

对于 关键

documented

and

explained.

Critical

deviations

should

be

investigated,

and

the

investigation

and

its

conclusions

should

be

documented.

2.17

No

materials

should

be

released

or

used

before

the

satisfactory

completion

of

evaluation

by

the

quality

unit(s)

unless

there

are

appropriate

systems

in

place

to

allow

for

such

use

(e.g.,

release

under

quarantine

as

described

in

Section

10

or

the

use

of

raw

materials

or

intermediates

性偏差应当进行调查，

并记录调查经

过及其结果。

2.17

在质量部门对物料完成满意的

评价之前，

任何物料都不应当发放 或

使用，

除非有合适的系统允许此类使

用

（如

10.20

条款所述的待检情况 下

的使用，

或是原料或中间体在等待评

价结束时的使用）

。

pending

evaluation).

completion

of

2.18

Procedures should exist for

2.18

应当有规程能确保公司的责任

notifying

responsible

management

in a timely manner of regulatory

inspections,

serious

GMP

deficiencies,

product

defects

and

related

actions

(e.g.,

quality-related

complaints,

recalls,

and

regulatory

actions).

2.2

Responsibilities

of

the

Quality Unit(s)

2.20

The quality unit(s) should

be

involved

in

all

quality-related matters.

2.21

The quality unit(s) should

管理部门能及时得到有关药政检查、

< br>严重的

GMP

缺陷、

产品缺陷及 其相关

活动

（如质量投诉，

召回，

药政活动

等）的通知。

2.2

质量部门的责任

2.20

质量部门应当参与所有与质 量

有关的事物。

2.21

所有与质量有关的文件应当由

review

and

approve

all

质量部门审核批准。

appropriate

quality-related

documents.

2.22

The

main

responsibilities

of

the independent quality unit(s)

should

not

be

delegated.

These

responsibilities

should

be

described in writing and should

include, but not necessarily be

limited to:

1.

Releasing

or

rejecting

all

APIs. Releasing or rejecting

intermediates for use outside

the

control

of

the

manufacturing company

2.

Establishing

a

system

to

release

or

reject

raw

materials,

intermediates,

packaging,

and

labeling

2.22

独立的质量部门的主要职责 不

应当委派给他人。

这些责任应当以文

字形式加以说明，

而且应当包括，

但

不 限于：

1.

所有原料药的放行与否。用于生

产商控制范围以外的中间体的放

行与否；

2.

< br>建立一个放行与拒收原材料、中

间体、包装材料和标签的系统；

< br>

3.

在供销售的原料药放行 前，审核

已完成的关键步骤的批生产记录

和实验室检验记录；< /p>

4.

确保已 对重大偏差进行了调查并

已解决；

5.

批准所有的规格标准和主生产指

materials

令；

3.

Reviewing

completed

batch

6.

批准所有可能影响原料药和中间

production

and

laboratory

control

records

of

critical

体质量的规程；

process steps before release

of the API for distribution

4.

Making

sure

that

critical

deviations

are

investigated

and resolved

5.

Approving all specifications

and

master

production

instructions

6.

Approving

all

procedures

affecting

the

quality

of

intermediates or APIs

7.

Making

sure

that

internal

audits

(self-inspections)

are

performed

8.

Approving

intermediate

and

7.

确保进行内部审计（自检）

；

8.

批准中间体或原料药的委托生产

商；

9.

批准可能影响到中间体或原料药

质量的变更；

10.

审核并批准验证方案和报告；

11.

确保调查并解决质量问题的投

诉；

12.

确保用有效的体系来维护和校

验关键设备；

13.

确保物料都经过了适当的检验

并报告结果；

14.

确保有稳定性数据支持中间体

或原料药的复验期或有效期和储

存条件；

API contract manufacturers

9.

Approving

potentially

changes

that

affect

15.

开展产品质量审核（详见

2.5

节）

。

intermediate or API quality

10.

Reviewing

validation

reports

11.

Making

sure

that

and

approving

and

protocols

quality-related

complaints

are investigated and resolved

12.

Making

sure

that

effective

systems

are

used

for

maintaining

and

calibrating

critical equipment

13.

Making

sure

that

materials

are appropriately tested and

the results are reported

14.

Making

sure

that

there

is

stability

data

to

support

retest

or

expiry

dates

and

storage

conditions

on

APIs

and/or

intermediates,

where

appropriate

15.

Performing

product

quality

reviews

(as

defined

in

Section

2.5

)

2.3

Responsibility

for

Production Activities

The

responsibility

for

production activities should be

described in writing and should

include, but not necessarily be

limited to:

1.

Preparing,

reviewing,

approving,

and

distributing

the

instructions

for

the

production

of

intermediates

or APIs according to written

2.3

生产作业的职责

生产作业的职责应当以文字形式加

以说明，

并应当包 括，

但不限于以下

内容：

1.

按书面程序起草、审核、批准和

分发中间体或原料药的生产指

令；

2.

按照已批准的指令生产原料药或

者中间体；

3.

审核所有的批生产记录确保其完

procedures

整并有签名；

2.

Producing

APIs

and,

when

4.

确保所有的生产偏差都已报告、

appropriate,

intermediates

评价，

对关键的偏差已做了调查，

并记录结论；

according

to

pre- approved

instructions

3.

Reviewing

all

production

batch

records

and

ensuring

that these are completed and

signed

4.

Making

sure

that

all

production

deviations

are

reported

and

evaluated

and

that critical deviations are

investigated

and

the

conclusions are recorded

5.

Making

sure

that

production

facilities

are

clean

and,

when

appropriate, disinfected

6.

Making

sure

that

the

necessary

calibrations

are

performed

5.

确保生产设施的清洁，必要时要

消毒；

6.

确保进行必要的校验，

并有记录；

7.

确保对厂房和设备进行保养，并

有记录；

8.

确保验证方案和报告的审核与批

准；

9.

对产品、工艺或设备拟作的变更

进行评估；

10.

确保新的或已改进的生产设施

和设备经过了确认。

and records kept

7.

Making sure that the premises

and equipment are maintained

and records kept

8.

Making

sure

that

validation

protocols

and

reports

are

reviewed and approved

9.

Evaluating

proposed

changes

in

product,

process

or

equipment

10.

Making

sure

that

new

and,

when

appropriate,

modified

facilities and equipment are

qualified

2.4

Internal

Audits

(Self

Inspection)

2.40

To

verify

compliance

with

the principles of GMP for APIs,

2.4

内部审计（自检）

2.40

为确实符合原料药

GMP

原则，

应当按照批准的计划进行定期的内

regular

internal

audits

should

be

部审计。

performed in accordance with an

approved schedule.

2.41

Audit

findings

and

corrective

actions

should

be

documented

and

brought

to

the

attention

of

responsible

management

of

the

firm.

Agreed

corrective

actions

should

be

completed

in

a

timely

and

effective manner.

2.5 Product Quality Review

2.50

Regular quality-reviews of

APIs

should

be

conducted

with

the

objective

of

verifying

the

consistency of the process. Such

reviews

should

normally

be

conducted

and

documented

2.41

审计结果及整改措施应当形 成

文件，

并引起公司责任管理人员的重

视。

获准的整改措施应当及时、

有效

地 完成。

2.5

产品质量审核

2.50

原料药的定期质量审核应当 以

证实工艺的一致性为目的来进行。

此

种审核通常应当每年进行一次，

并记

录，内容至少应当包括：< /p>

●

关键工艺 控制以及原料药关

键测试结果的审核；

annually

and

should

include

at

least:

●

A

review

of

critical

in- process

control

and

critical API test results

●

A

review

of

all

batches

that

failed

to

meet

established

specification(s)

●

A

review

of

all

critical

deviations

or

nonconformances

and

related investigations

●

A

review

of

any

changes

carried

out

to

the

processes

or

analytical

methods

●

A review of results of the

stability

monitoring

●

所有不符合既定质量标准的

产品批号的审核；

●

所有关键的偏差或违规行为

及有关调查的审核；

●

任何工艺或分析方法变动的

审核；

●

稳定性监测的审核；

●

所有与质量有关的退货、

投诉

和召回的审核；

●

整改措施的适当性的审核。

program

●

A

review

of

all

quality- related

returns,

complaints and recalls

●

A

review

of

adequacy

of

corrective actions

2.51

The results of this review

should

be

evaluated

and

an

assessment

made

of

whether

corrective

action

or

any

revalidation

should

be

undertaken.

Reasons

for

such

corrective

action

should

be

documented.

Agreed

corrective

actions should be completed in a

timely and effective manner.

3. PERSONNEL

2.51

应当对质量审核结果进行评

估，

并做出是否需要整改或做任何再

验 证的评价。

此类整改措施的理由应

当文件化。获准的整改措施应 当及

时、有效地完成。

3.

人员

3.1 Personnel Qualifications

3.1

员工的资质

3.10

There should be an adequate

3.10

应当有足够数量的员工具备从

number of personnel qualified by

事和监管原料药和中间体生产的教

appropriate

education,

training,

育、培训和

/

或经历等资格。

and/or experience to perform and

supervise

the

manufacture

of

intermediates and APIs.

3.11

The responsibilities of all

personnel

engaged

in

the

manufacture

of

intermediates

and

APIs

should

be

specified

in

writing.

3.12

Training

should

be

regularly

conducted

by

qualified

individuals and should cover, at

a

minimum,

the

particular

operations

that

the

employee

performs

and

GMP

as

it

relates

to

3.11

参与原料药和中间体生产的 所

有人员的职责应当书面规定。

3.12

应当由有资格的人员定期进 行

培训，

内容至少应当包括员工所从事

的特定操作和与其职能有关的

GMP

。

培训记录应当保存，

并应当定期对培

训进行评估。

the

employee

’

s

functions.

Records

of

training

should

be

maintained.

Training

should

be

periodically assessed.

3.2 Personnel Hygiene

3.20

Personnel

should

practice

good

sanitation

and

health

habits.

3.21

Personnel should wear clean

clothing

suitable

for

the

manufacturing

activity

with

which they are involved and this

clothing should be changed, when

appropriate.

Additional

protective

apparel,

such

as

head,

face,

hand,

and

arm

coverings,

should be worn, when necessary,

to

protect

intermediates

and

APIs

3.2

员工的卫生

3.20

员工应当养成良好的卫生和健

康习惯。

3.21

员工应当穿着适合其所从事生

产操作的干净服装，必要时应当更

换。

其它保护性用品如头、

脸、

手和< /p>

臂等遮护用品必要时也应当佩带，

以

免原 料药和中间体受到污染。

from contamination.

3.22

Personnel

should

avoid

3.22

员工应当避免与中间体或原料

direct

contact

with

药的直接接触。

intermediates and APIs.

3.23

Smoking, eating, drinking,

chewing and the storage of food

should be restricted to certain

designated

areas

separate

from

the manufacturing areas.

3.24

Personnel suffering from an

infectious

disease

or

having

open

lesions

on

the

exposed

surface

of

the

body

should

not

engage

in

activities that could result in

compromising

the

quality

of

APIs.

Any

person

shown

at

any

time

(either

by

medical

examination

or

supervisory

observation)

to

have

3.23

吸烟、吃、喝、咀嚼及存放 食

品仅限于与生产区隔开的指定区域。

3.24

患传染性疾病或身体表面有 开

放性创伤的员工不应当从事危及原

料药质量的生产活动。在任 何时候

（经医学检验或监控检查）

任何患有

危及到原料药质量的疾病或创伤的

人员都不应当参与作业，

直到健康状

况已恢复，

或者有资格的医学人员确

认该员工不会危及到原料药的安全

an

apparent

illness

or

open

性和质量。

lesions should be excluded from

activities

where

the

condition

could

adversely

affect

the

quality

of

the

APIs

until

the

condition

is

corrected

or

qualified

medical

personnel

determine

that

the

person

’

s

inclusion

would

not

jeopardize

the

safety

or

quality

of

the

APIs.

3.3 Consultants

3.30

Consultants advising on the

manufacture

and

control

of

intermediates

or

APIs

should

have

sufficient education, training,

and

experience,

or

any

combination

thereof,

to

advise

on

the subject for which they are

retained.

3.3

顾问

3.30

中间体或原料药生产和控制 的

顾问应当有足够的学历，受训和经

验，能胜任所承担的工作。

3.31

Records

should

be

maintained

3.31

顾问的姓名、地址、资格和提

stating

the

name,

address,

供服务的类型都应当有文字记录。

qualifications,

and

type

of

service

provided

by

these

consultants.

4. BUILDINGS AND FACILITIES

4.1 Design and Construction

4.10

Buildings

and

facilities

used

in

the

manufacture

of

intermediates and APIs should be

located,

designed,

and

constructed

to

facilitate

cleaning,

maintenance,

and

operations as appropriate to the

type

and

stage

of

manufacture.

Facilities

should

also

be

designed

to

minimize

potential

contamination.

Where

4.

建筑和设施

4.1

设计和结构

4.10

用于中间体和原料药生产的厂

房和设施的选址、

设计 和建造应当便

于清洁，

维护和适应一定类型和阶段

的生产操作。

设施的设计应尽量减少

潜在的污染。< /p>

如果中间体或原料药的

生产有微生物限度要求，

< br>那么设施设

计应相应的限制有害微生物的污染。

microbiological

specifications

have

been

established

for

the