产品技术转移

Product Technical Transfer

产品技术转移

1 Objective 目的

This procedure defines the procedure for the product technical transfer from the

transferor to transferee. Make sure the technical transfer follows a standard

procedure, to ensure that products are produced and stored according to

appropriate documentation in order to obtain the required quality.

本规程规定了产品技术由转出方转移到接收方的标准操作流程，使产品引入过程规范

地运作，有效地评估和控制新产品引入的风险，找出产品工艺和质量控制的关键控制

点，确保产品能顺利稳定地转移至生产线进行投产，稳定高效地生产出符合产品质量

标准的产品。

2 Scope范围

This SOP applies to the technical transfer of all the products from different

resources including research institutes and companies cooperation with SLP.

本规程适用于所有来源的产品，包括由研发机构或其它公司向生产线技术转移的所有

产品。

3 Responsibilities 职责

3.1 TD is responsible for drafting, reviewing, revising, training and implementing this

SOP.

技术部负责本规程的起草、审核、修订、培训和执行。

3.2 QA, QC, production, logistic department is responsible for reviewing and

supervising the implementation of this procedure.

QA、QC、生产及物控部门负责审核并监督本规程的执行。

3.3 Quality director is responsible for approving this procedure.

质量总监负责本规程的批准。

3.4 Technical transfer staff should understand and implement this procedure.

技术转移相关人员理解并执行本规程。

4Definitions 定义

4.1 Technical transferor refers to the original manufacture or institutes who keep the

technical data.

技术转出方是指持有产品技术资料的原生产商或研究单位。

4.2 Technical transferee refers to the team that consist of TD, PD, QC, QA, etc..

技术接收方是指由技术部、生产部、QC部、QA部等部门成员组成的项目组。

5 Procedures 程序

5.1 Classification by product source

产品来源分类

5.1.1 Domestic contract processing product

国内委托加工产品

Domestic contract processing refers to the processing producing products basing

on the drug regulations of China and the target market will be the Chinese mainland.

国内委托加工是指协助国内企业按照中国法规要求生产且最终产品在中国境内上市

销售的产品。

5.1.2 Overseas contract processing product

境外委托加工产品

Overseas contract processing refers to contract processing producing products

basing on EP, USP, JP, BP ect. and the target market will be the overseas.

境外代加工是指协助其它企业按照国外法规要求生产且最终产品在境外上市销售的

产品。

5.1.3 Registry product

公司注册产品

Other companies or institutes transfer their technical achievement, technology and

information to our company by various means, and we will have the all or part of the

ownership of the product. For example, ANDA, NDA and new product which will be

declared in domestic.

外部企业或研究单位通过各种方式将科学技术成果、技术、信息转让给我公司，最终

我公司拥有该技术的全部或部分所有权的产品，如ANDA、NDA、国内新药申报产

品等。

5.2 Procedure of product technical transfer

产品技术转移程序

5.2.1 Establish the project of product technical transfer

建立产品技术转移项目

5.2.1.1 Confirm the development status of process and analytical methods of transfer

project.

确定产品技术转移项目的产品的处方和工艺研发的状态。

5.2.1.2 Designate the responsible person of the transferor and the transferee, establish

technical transfer team.

确定转出方和接收方项目负责人，组建技术转移小组。

5.2.1.3 The transferee team review the technical documents referred by transferor,

according to . Sign on

Transfer Record> to confirm they comply with requirement. Copy or scan reference

documents used in test methods transfer.

技术转移小组审核技术转出方提交的转移资料，审核工作参见《通用产品技术转移检

查表》。核对文件清单，确认符合要求和法规规定后在《技术转移记录》上签字确认。

相关文件复印一份或扫描一份用于分析方法转移工作。

5.2.2 Risk assessment and change control of the product technical transfer

转入产品技术转移风险评估和变更控制

5.2.2.1 Risk assessment should follow as the two ways:

新产品引入的风险评估分为下列两个方面进行：

●TD manager should organize the risk assessment regarding to the interaction

from the new product and current products .Assess the affect to current

materials, premises, facilities, equipments, personnel, documentation,

regulations, production, lab control, packaging, labeling. Identify the feasibility of

the transfer and the following work. Refer to < Risk Assessment for Product

Technical Transfer >.

技术部经理应组织对引入的新产品可能对现有生产线的物料、厂房、设施、设备、

人员、文件、法规、生产、实验室控制、包装与标签等相关方面产生的影响和生

产线现有产品对新引入产品的影响进行风险评估，确定转移的可行性和需要开展

的工作。参见《新产品引入风险分析表》。

●Project manager should organize the risk assessment of the process and quality

control for the new product. Identify the optimization and validation activities

against the problems and potential risks. Refer to

Risk Assessment >.