-
8.
Documentation
文件
8.1 The
documentation required for the transfer project
itself is wide ranging.
Examples of
documentation commonly required are summarized in
Table 2.
项目转移本身文件要求范围很宽。常规要求的文件举例归纳在表
2
中。
8.2
The documented evidence that the transfer of
technology has been considered
successful should be formalized and
stated in a technology transfer summary report.
That report should summarize the scope
of the transfer, the critical parameters as
obtained in the SU and RU (preferably
in a tabulated format) and the final conclusions
of the transfer. Possible discrepancies
should be listed and appropriate actions, where
needed, taken to resolve them.
< br>一个技术转移被认为是成功的时候，证明其成功的文件证据需要正式化，并在技
术
转移总结报告中申明。该报告应总结转移的范围、转出单位和接收单位所获得
的关键参数
（最好以表格形式）
、转移的最终结论。应列出可能的差异，如果需
要时，应采取可能的措施解决并记录。
Table 2
表
2
Examples of
documentation for transfer of technology (TOT)
Key task
关键任务
Project
definition
项目定义
技术转移文件举例（
TOT
）
Documentation
provided by
Transfer documentation
SU
转移文件
转出方提供的文件
Project
plan and quality plan
(where separate
documents),
protocol, risk assessments,
gap
analysis
项目计划和质量计划（如果文
件分开），方案、风险评估、
差异分析
Quality agreement
质量协议
Facility
assessment
设施评价
Plans and layout of facility,
buildings (construction, finish)
设施和厂房的平面图（建筑、
处理方
法）
Qualification status (DQ,
IQ,
OQ) and reports
确认状态（
DQ, IQ,
OQ
）和报
告
Health & Safety
assessment
卫生和安全评价
Product-specific waste
management plans
产品专用废物管理计划
Contingency plans
应急方案
Skill set
analysis and
SOPs and training
Training protocols,
training
documentation (product-specific
assessment results
operations, analysis, testing)
< br>熟练程度分析和培
培训方案，评价和结果
训
SOP
和
培训文件（产品专用操
作、分析检测
）
Analytical method
Analytical
method specification
Analytical method
transfer
Side-by-side comparison
with RU facility and
buildings; gap analysis
与接收单
位设施、建筑进
行一一对照比较，差异分
析
Qualification protocol
and report
确认方案和报告
Project implementation
plan
项目实施计划
TOT
protocol
TOT
方案
Key task
关键任务
transfer
分析方法转移
Documentation provided by
SU
转出方提供的文件
and
validation, including
in-process
quality control
分析方法质量标准和验证，包
括中控质量控制
Transfer
documentation
转移文件
protocol and
report
分析方法转移方案和报
告
Starting material
evaluation
起始物料评价
Equipment selection
and
transfer
设备选择和转移
Specification and additional
information on APIs,
excipients
原料药和辅料的质量标准和额
外信息
Inventory list of all equipment
and systems, including makes,
models, qualification status (IQ,
OQ, PQ)
Side-by-side
comparison
with RU equipment
(makes, models,
qualification status)
所有设备和系
统清单，包括品
与接收单位的设备一一
牌、型号、确认状态（<
/p>
IQ, OQ,
对照比较（品牌、型号、
PQ
）
确认状态）
Drawings,
manuals, logs, SOPs
Gap analysis
(e.g. set-up, operation, cleaning,
差异分析
maintenance,
calibration,
Qualification and
storage)
validation protocol
and
图纸、手册、日志、
SOP
（
例
report
如设定、操作、清洁
、维护、
确认和验证方案和报告
校正、存储）
Process
transfer:
manufacturing and
packaging
工艺转移生产和包
装
Reference bathes (clinical,
dossier, biobatches)
History
of process
development at RU
参考（临床，文件，生物批）
接收单位工艺研发历史
Development report
(manufacturing process
rationale)
Experience at RU
should
be recorded for future
reference
研发报告（生产工艺合理性）
接收单位的经验应记录
作为将来参考
History of critical analytical data
Provisional batch
关键分析数据历史
manufacturing document
Rationale for specifications
(RU to develop)
临时批次生产文件（接收
Key
task
关键任务
Documentation provided by
SU
转出方提供的文件
质量标准论述
Change
control documentation
变更控制文件
Critical manufacturing process
parameters
关键生产工艺参数
Process
validation reports
工艺验证报告
Drug master file
药物主文件
API
validation status and
report(s)
原料药验证状态和报告
Product stability data
产品稳定性数据
Current
master batch
manufacturing and
packaging
records
List of
all batches produced
所有生产批次清单
Deviation reports
偏差报告
Investigations, complaints,
recalls
Annual product
review
调查、客诉、召回、年度产品
回顾
Transfer documentation
转移文件
单位制订）
Provisional
batch
packaging document (RU
to develop)
临时批次包装文件（接收
单位负责制订）
Description of
process at
RU (narrative, process
map, flow chart)
接收单位的工艺描述（叙
述、
工艺图、流程图）
Process
validation
protocol and report
工艺验证方案和报告
Cleaning
清洁
Cleaning validation, including
solubility information,
therapeutic doses, category
Product and site-specific
cleaning SOPs at RU
接受单位产品和场所专
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