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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
记录对任何
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
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