cat翻译FDA-GMP中英文对照标准版

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整并有签名；

4.

确保所有的生产偏差都已报告、评价，对关键的偏 差已做了调查，并记录结论；

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。

8

2.4 Internal Audits (Self Inspection) 2.4

内部审计（自检）

2.40 To verify compliance with the principles of GMP for APIs, regular internal audits should be performed

in accordance with an approved schedule.

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部审计 。

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.

2.41 < /p>

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。

< br>

2.5 Product Quality Review 2.5

产品质量审核

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 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 program

A review of all quality-related returns, complaints and recalls

A review of adequacy of corrective actions

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：

关键工艺控制以及原料药关键测试结果的审核；

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。

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.

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. PERSONNEL 3.

人员

3.1 Personnel Qualifications 3.1

员工的资质

3.10

There

should

be

an

adequate

number

of

personnel

qualified

by

appropriate

education,

training,

and/or experience to perform and supervise the manufacture of intermediates and APIs.

3.10

应当有足够数量的员工具备从事和监 管原料药和中间体生产的教育、培训和

/

或经历等资格。

3.11 The responsibilities of all personnel engaged in the manufacture of intermediates and APIs should be

specified in writing.

9

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 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

the

employee

’

s

functions.

Records of training should be maintained. Training should be periodically assessed.

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。

3.2 Personnel Hygiene 3.2

员工的卫生

3.20 Personnel should practice good sanitation and health habits.

3.20

员工应当养成良好的卫生和健康习惯。

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

from contamination.

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。

3.22 Personnel should avoid direct contact with intermediates and APIs.

3.22

员工应当避免与中间体或原料药的直接接触。

3.23 Smoking, eating, drinking, chewing and the storage of food should be restricted to certain designated

areas separate from the manufacturing areas.

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 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 an apparent illness

or open 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.

3.24

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< /p>

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性和质量。

3.3 Consultants 3.3

顾问

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.

3.30

< br>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 stating the name, address, qualifications, and type of service provided

by these consultants.

3.31

顾问的姓名、地址、资格和提供服务的类型都应当有文字记录。

10

4. BUILDINGS AND FACILITIES 4.

建筑和设施

4.1 Design and Construction 4.1

设计和结构

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

microbiological

specifications

have

been established for the

intermediate

or

API, facilities

should

also be

designed to limit exposure to objectionable microbiological contaminants, as appropriate.

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。

如 果中间体或原料药的生产有微生物限度要

求，那么设施设计应相应的限制有害微生物的污 染。

4.11

Buildings

and

facilities

should

have

adequate

space

for

the

orderly

placement

of

equipment

and

materials to prevent mix-ups and contamination.

4.11

厂房 和设施应有足够空间，以便有秩序地放置设备和物料，防止混淆和污染。

4.12

Where

the

equipment

itself

(e.g.,

closed

or

contained

system)

provides

adequate

protection

of

the

material, such equipment can be located outdoors.

4.12

自身能对物料提供足够 保护的设备（如关闭的或封闭的系统）

，可以在户外放置。

4.13 The flow of materials and personnel through the building or facilities should be designed to prevent

mix-ups and contamination.

4.13

通过厂房和设施的物流和人流的设计应当能防止混杂和污染。

4.14 There should be defined areas or other control systems for the following activities:

以下活动应当有指定区域或其它控制系统：

4.15

Adequate

and

clean

washing

and

toilet

facilities

should

be

provided

for

personnel.

These

facilities

should be equipped with hot and cold water, as appropriate, soap or detergent, air dryers, or single service

towels. The washing and toilet facilities should be separate from, but easily accessible to, manufacturing

areas. Adequate facilities for showering and/or changing clothes should be provided, when appropriate.

4.15

应当为员工提供足够和清洁的盥洗设施。这些盥洗设 施应当装有冷热水（视情况而定）

、肥皂或

洗涤剂，干手机和一 次性毛巾。盥洗室应当与生产区隔离，但要便于达到。应当根据情况提供足够的

淋浴和< /p>

/

或更衣设施。

4.16

Laboratory

areas/operations

should normally

be

separated

from production

areas.

Some

laboratory

areas,

in

particular

those

used

for

in-process

controls,

can

be

located

in

production

areas,

provided

the

operations of the production process do not adversely affect the accuracy of the laboratory measurements,

and the laboratory and its operations do not adversely affect the production process, intermediate, or API.

4.16

实 验室区域

/

操作通常应当与生产区隔离。有些实验室区域，特别 是用于中间控制的，可以位于

生产区内，

只要生产工艺操作对实 验室测量的准确性没有负面影响，

而且，

实验室及其操作对生产 过

程，或中间体，或原料药也没有负面影响。

4.2 Utilities 4.2

公用设施

4.20 All utilities that could affect product quality (e.g., steam, gas, compressed air, heating, ventilation, and

air conditioning) should be qualified and appropriately monitored and action should be taken when limits

are exceeded. Drawings for these utility systems should be available.4.20

对产品质量会有影响的所有公< /p>

用设施（如蒸汽，气体，压缩空气和加热，通风及空调）都应当确认合格，并进行适当监控 ，在超出

11

限度时应当采取相应措施。应当有这些公用设施的系统图。

4.21 Adequate ventilation, air filtration and exhaust systems should be provided, where appropriate. These

systems should be designed and constructed to minimize risks of contamination and cross-contamination

and should include equipment for control of air pressure, microorganisms (if appropriate), dust, humidity,

and temperature, as appropriate to the stage of manufacture. Particular attention should be giving to areas

where APIs are exposed to the environment.

4.21 < /p>

应当根据情况，提供足够的通风、空气过滤和排气系统。这些系统应当根据相应的生产阶段 ，设

计和建造成将污染和交叉污染降至最低限度，并包括控制气压、微生物（如果适用）

、灰尘、湿度和

温度的设备。特别值得注意的是原料药暴露的区 域。

4.22

If

air

is

recirculated

to

production

areas,

appropriate

measures

should

be

taken

to

control

risks

of

contamination and cross- contamination.

4.22

如果空气再循环到 生产区域，应当采取适当的控制污染和交叉污染的风险。

4.23

Permanently

installed

pipework

should

be

appropriately

identified.

This

can

be

accomplished

by

identifying

individual

lines,

documentation,

computer

control

system,

or

alternative

means.

Pipework

should be located to avoid risks of contamination of the intermediate or ApI.

4.23

< br>永久性安装的管道应当有适宜的标识。

这可以通过标识每根管道、

提供证明文件、

计算机控制系

统，或其它替代方法来达 到。管道的安装处应当防止污染中间体或原料药。

4.24 Drains should be of adequate size and should be provided with an air break or a suitable device to

prevent back- siphonage, when appropriate.

4.24

排水沟应当有足够的尺寸，而且应当根据情况装有空断器或适当的装置，防止倒虹吸。

4.3 Water 4.3

水

4.30 Water used in the manufacture of APIs should be demonstrated to be suitable for its intended use.

4.30

原料药生产中使用的水应当证明适合于其预定的用途。

4.31

Unless

otherwise

justified,

process

water

should,

at

a

minimum,

meet

World

Health

Organization

(WHO) guidelines for drinking (portable) water quality.

除非有其它理由，工艺用水最低限度应当符合世界卫生组织（

WHO

）的饮用水质量指南。

4.32

If

drinking

(portable)

water

is

insufficient

to

ensure

API

quality

and

tighter

chemical

and/or

microbiological water quality specifications are called for, appropriate specifications for physical/chemical

attributes, total microbial counts, objectionable organisms, and/or endotoxins should be established.

4.32

如果饮用 水不足以确保原料的质量，并要求更为严格的化学和

/

或微生物 水质规格标准，应当指

定合适的物理

/

化学特性、微生物总数、控制菌和

/

或内毒素的规格标准。

4.33

Where

water

used

in

the

process

is

treated

by

the

manufacturer

to

achieve

a

defined

quality,

the

treatment process should be validated and monitored with appropriate action limits.

4.33

在工艺用水为达到规定 质量由制造商进行处理时，

处理工艺应当经过验证，

并用合适的 处置限度

来监测。

4.34

Where

the

manufacturer

of

a

nonsterile

API

either

intends

or

claims

that

it

is

suitable

for

use

in

further

processing

to

produce

a

sterile

drug

(medicinal)

product,

water

used

in

the

final

isolation

and

purification steps should be monitored and controlled for total microbial counts, objectionable organisms,

12

and endotoxins.

4.34

当非无菌原 料药的制造商打算或者声称该原料药适用于进一步加工生产无菌药品

（医疗用品）

时，

最终分离和精制阶段的用水应当进行微生物总数、致病菌和内毒素 方面的监测和控制。

4.4 Containment 4.4

限制

4.40

Dedicated

production

areas,

which

can

include

facilities,

air

handling

equipment

and/or

process

equipment,

should

be

employed

in

the

production

of

highly

sensitizing

materials,

such

as

penicillins

or

cephalosprins.

4.40

在高致敏性物质，如青霉素或头孢菌素类的生产中，应当使用专用的生产区，包括设施、空气处

理设备和

/

或工艺设备。

4.41

The

use

of

dedicated

production

areas

should

also

be

considered

when

material

of

an

infectious

nature or high pharmacological activity or toxicity is involved (e.g., certain steroids or cytotoxic anti-cancer

agents) unless validated inactivation and/or cleaning procedures are established and maintained.

4.41

当涉及具有感染性、高药理活性或毒性的物料时（如，激素类或抗肿瘤类）

，也应当考虑专用的

生产区，除非已建立并维持一套经验证的灭活和