Product Technical Transfer
产品技术转移
1Objective 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。
2Scope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。
3Responsibilities 职责
3.1TD 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。
3.2QA, 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。
3.3Quality director is responsible for approving this procedure.
质量总监负责本规程的批准。
3.4Technical 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
4.1Technical 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。
4.2Technical 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。
5Procedures 程序
5.1Classification by product source
产品来源分类
5.1.1Domestic 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。
5.1.2Overseas 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。
5.1.3Registry 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。
5.2Procedure of product technical transfer
产品技术转移程序
5.2.1Establish the project of product technical transfer
建立产品技术转移项目
5.2.1.1Confirm 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。
5.2.1.2Designate 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。
5.2.1.3The transferee team review the technical documents referred by transferor, according to Checklist>. Sign on 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。 5.2.2Risk 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 5.2.2.1Risk 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 Process and Quality Risk Assessment >. 项目负责人应组织质量研究和工艺研究人员对引入的新产品的工艺研究和质量研 究的情况进行风险分析，针对存在的问题和风险制订相应的优化措施和验证措施。 参见《新产品工艺和质量风险分析表》。 5.2.2.2Change control 变更控制 A new product transfer into plant is in the range of change control, Basing on the result of risk assessment, supervise the process according to the manage procedure of measures combine with the product transfer protocol, avoid the influence between original products and the new introduced product. 在生产线上引入新的产品属于变更控制范围，基于风险评估的结果，对于可执行的项 目根据《变更控制》管理程序进行过程的监控，与产品转移方案相结合采取相应措施， 避免原有产品和新引入的产品的相互影响。 5.2.3Prepare technical transfer plan 编写技术转移计划 5.2.3.1Write technical transfer plan according to the process flow and the company’s technical transfer strategy. 根据新引入产品的工艺流程和公司技术转移策略等编写技术转移计划。 5.2.3.2Technical transfer protocol and technical transfer list should be written by personnel assigned by the responsible person from the transferee. And it should be approved by the quality director. 技术转移计划由接收方项目负责人指定专人编写，经转移小组审核后由质量总监批 准。 5.2.3.3The transferee’s responsible person should organize the maintenance and amendment of the technical transfer plan. 技术转移计划由接收方负责人负责组织进行维护和修订。 5.2.4The transferee’s responsible person should organize drafting the product validation master plan and make it a guide to the validation work when a new product is introduced. Make sure the introduction process is effectively controlled and verified. 接收方负责人负责组织编写产品验证主计划，为新产品的引入所产生的验证工作提供 文件指导和规划，保证产品引入过程中相关工作得到有效的控制和确认。 5.2.4.1Numbering of the product validation master plan: PVMP-Project code-Serial No., refer to Organization and Implementation>. 产品验证主计划的编号原则：PVMP－项目编号－版本号，参见《验证的组织和实施》。 5.2.4.2Product validation master plan should include but not limited to: Product introduction and product-related validation plan introduction Responsibilities of relevant departments Acceptance criteria of the process development, analytical development and cleaning residue at different stages of the product transfer Validation list of relevant equipment, utilities and facilities Validation list of the method validation, cleaning validation, process validation and packaging validation. Validation documentation list 产品验证主计划应该包括但是不限于下列内容： 产品概述和产品相关验证的总体计划简介。 产品引入相关部门的职责和分工。 从产品转移开始各阶段的工艺研究、质量研究和清洁残留的接受标准。 引入产品相关的设备、设施和公用系统的验证清单。 引入产品的分析方法验证、清洁验证、工艺验证和包装验证清单。 相关验证文件列表。 5.2.5Analytical test methods transfer 分析方法转移 5.2.5.1Establish a quality development team who is responsible for the analytical method transfer. Assign responsibilities for the team leader and every team member. 成立负责分析方法转移工作的质量研究小组，确定项目质量研究负责人，明确项目组 成员工作职责分工。 5.2.5.2Quality development team implements the analytical method transfer according to technical transfer plan and SOP 质量研究小组根据技术转移项目计划和标准操作程序《分析方法转移》的要求执行分 析方法转移工作。 5.2.5.3Quality development team leader should draft an analytical method transfer plan as well as an analytical method training plan. The analytical method training plan should include the explaining and site operation. Quality development team leader organize the training of the analysts and QA personnel, to ensure that trainees understand the procedures correctly, and implement the key points of the new method in an accurate way. 项目质量研究负责人在制定分析方法转移计划的同时应制定分析方法培训计划，包括 新产品分析方法讲析和实际操作两个方面。对负责转移和接受分析方法操作的QC分 析人员和相关QA人员进行有效的培训，确保相关分析人员能正确理解分析程序，准 确无误地执行新产品分析方法的操作要领。 5.2.6Pharmaceutical technology transfer 工艺技术转移 5.2. 6.1Establish a process development team who is responsible for the product process transfer. Assign responsibilities for the team leader and every team member. 成立负责工艺技术转移工作的项目工艺研究小组，确定项目工艺研究负责人，明确项 目组成员工作职责分工。 5.2. 6.2Process development team leader organize the reviewing of the product formulation and process documents provided by the transferor, including: Feasibility of the process Rationale of the quality specification Current production capacity against the production demand 项目工艺研究负责人组织相关人员对产品转出方提供的产品处方和工艺资料进行审 核： 产品工艺的可行性。 质量标准设置的合理性。 公司现有生产工艺条件是否满足产品生产需求。
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