FDA认证检查的六大系统

1

QUALITY SYSTEM

质量保证系统

1.1

Product reviews (annual)

产品审 查

(

年度

)

1.2

Complaint reviews (quality and medical)

投诉审查

(< /p>

质量和医疗

)

1.3

Discrepancy and failure investigations

不一致和失败的调查

1.4

Document Control

文件控制

1.5

Batch release

批放行

1.6

Change Control

变更控制

1.7 < /p>

Reprocess/Rework

再加工

/

返工

1.8

Returns/Salvages

退回

/

补救

1.9

Rejects

拒收

1.10

1.11

Stability Failures

稳定性失败

Quarantine

待验

1.12

Validation: computer, equipment, process, laboratory methods,

cleaning

验证：计算机、设备、工艺、实验方法、清洁

1.13

1.14

1.15

Training/qualification

培训

/

资质

internal Audit Program

内审规程

Supplier Audit Program

供应商审计规程

2

FACILITIES AND EQUIPMENT SYSTEM

厂房设施与设备系统

I Facilities

厂房设施

2.1

cleaning and maintenance

清洁与维护保养

2.2

facility layout and air handling systems

厂房设施布局与空气处理系统

2.3

general air handling systems

全面的空气处理系统

2.4

control system for implementing changes in the building

实施在 厂房

方面变更的控制系统

2.5

purified water and compressed air systems

纯化水与压缩空气系统

2.6

lighting, potable water, washing and toilet facilities, sewage and

refuse -disposal

照明、饮用水、清洗和盥洗 设施、污水及垃圾处理

2.7

sanitation of the building, use of rodenticides, fungicides,

insecticides, cleaning and sanitizing agents

厂房卫生、灭鼠剂、 杀真菌

剂、杀虫剂、清洗剂及消毒剂的使用

2.8

drawings (as built)

布局图

(

厂房

)

II Equipment

设备

?

equipment installation and operational qualification

< br>设备安装和运行

确认

?

adequacy of equipment design, size, material, construction and

location

适当的设备设计、大小、材质、结构与位置

?

appropriate use of equipment operations substances, (lubricants,

coolants, refrigerants, etc.) contacting products/containers/etc.

适当< /p>

的设备运行时接触产品

/

容器等物质的使 用（例如，润滑剂、冷却剂、制冷剂等

等）

?

cleaning procedures and cleaning validation

清洁规程与清洁验证

?

controls to prevent contamination, particularly with any pesticides

or any other toxic materials, or other drug or non-drug chemicals

预防

污染的控制措施、

尤其是杀虫剂或其它有 毒物质、

或其它药物与非药物化学物质

?

qualification, calibration and maintenance of refrigerators and

freezers

电冰箱和冷冻机的确认、校验和维护保养

?

equipment qualification, calibration and maintenance, including

computer qualification/validation and security

设 备确认、校准与维护保

养，包括计算机确认

/

< br>验证和安全

?

control system for implementing changes in the equipment

实施在设备

方面发生的变更 的控制系统

?

equipment identification practices (where appropriate)

设备验收

(

如

适用

)

?

documented investigation into any unexpected discrepancy

未期望的不一致的调查

3

MATERIALS SYSTEM

物料系统

3.1

training/qualification of personnel

人员的培训

/

资质

3.2

identification of components, containers, closures

组分、容器密封 件

的鉴定

3.3

inventory of components, containers, cl osures

组分、容器密封件的目

录

3.4

storage conditions

贮存条件

3.5

storage under quarantine

在隔离下的贮存

3.6

representative samples collected, tested or examined using

appropriate means

用适当的方法收集、检验和检查有代表性样品

3.7

at least one specific identity test is conducted on each lot of each

component

每个组分每一批，至少做一个专属性实验

3.8

a visual identification is conducted on each lot of containers and

closures

每批容器和 密封件，应做一个目测确认

3.9

testing or validation of supplier's test results for components,

containers and closures

对供应商的组分、容器和密封件的化验结果的检验或

验证

3.10

rejection of any component, container, closure not meeting

acceptance requirem ents

不符合可接受要求的组分、容器和密封件的拒收

3.11

appropriate retesting/reexamination of components, containers,

closures

组分、容器和密封件适当的复验

复查

3.12

first

in-first

out

use

of

components,

containers,

closures

组分、

容器和密封件的先入先出

3.13

quarantine of rejected materials

拒收物料的隔离

3.14

water

and

process

gas

supply,

design,

maintenance,

validation

and

operation

水与工艺用气的供应、设计、维护保养、验证和操作

3.15

control

system

for

implementing

changes

in

the

materials

handling

operations

实施在物料处理操作方面所发生的变更的控制系统

3.16

qualification/validation and security of computerized or

automated processes

计算机化或自动化过程的确认

/

验证和 安全