部门 Party/Department | 职责描述 Description of the responsibilities |
研发中心或上市许可持有人 R&D or MA Holder | 01.按照标准操作规程提供所有技术转移相关文件。 Provide all the documents for technology transfer as mentioned in the SOP. 02.生产工艺及检验方法的转移。 Transfer manufacturing process and Testing process 03.对相关人员进行生产及分析方法的培训。 Provide training to all relevant people about manufacturing and analytical process 04.与技术转移小组保持联络。 Responsible to maintain communication with Technology Transfer Team 05.处理技术转移阶段产生的偏差或超标事件。 Responsible to handle deviation or OOS occurred during technology transfer stage. 06.负责提供NOEL和LD 50数据以进行清洁过程评估。 Responsible to provide NOEL and LD 50 data for cleaning process asssment. |
生产技术部 Production Technology Department | 01.接收、审核及处理从研发中心或上市许可持有人获得的技术数据Receive, review and manage the technical data received from R&D or MA holder. ttf文件
; 02.技术转移过程中与相关部门进行协作，如研发、法规事务部、生产、质量、工程及供应链。进行技术监督，提供技术支持，跟进技术转移进度。 Coordinate the related departments as R&D, RA, Production, Quality, Engineering, and Supply chain during the technology transfer process. Provide technology supervision and support. And supervi and follow up progress of the technology transfer. 03.技术转移过程中与研发或上市许可持有人进行沟通。 Communicate with R&D or MA holder during technology transfer. 04.对生产区域进行差距分析，找出缺陷并在生产区域进行技术转移前解决问题。 Perform GAP analysis of production area, identify the deficiency and solve the problems before transferring the technology in manufacturing floor. 05.审核生产、QC及仓库的差距分析报告。 Review GAP analysis report from QC and warehou. 06.根据差距分析报告起草风险分析报告。 Prepare risk asssment report bad on the Gap analysis report. 07.向技术转移小组提出建议。Propo technology transfer team. 08.监督工艺优化、实验批、工艺验证及注册批的执行。 Monitor the execution of Process Optimization, trail, Process Validation or exabit batch. 09.技术转移过程中参与偏差调查及变更控制并负责协调及解决技术问题。 Coordinate deviation investigation and changes control during the transfer, and responsible for coordinating and ttling technical problems. 10.组织技术转移培训。Organize the training of technical transfer. 11.起草技术转移报告。Prepare tech transfer report |
QA | 01.审核技术转移计划、方案及报告。 Review technology transfer plans, protocols and reports. 02.参与技术转移过程中的偏差及变更调查和评估。 Participate in the investigation and evaluation of deviations and changes during the technology transfer. 03.监督产品技术转移过程中的质量及GMP符合性。 Responsible for quality and GMP compliance supervising during product technology transfer. 04.参与讨论解决技术问题。 Involve in the discussion of solutions for the technical problems 05.审核验证/确认项目并保证其合理性。 Review the validation/qualification initiation, and control its rationality. 06.处理并协调相关验证/确认工作。 Manage and coordinate the relevant validation/qualification task. 07.为验证/确认提供技术支持。 Provide the technical support for the validation/qualification. 08.负责产品技术转移数据的归档。 Responsible for archiving management of product technology transfer data. |
QC | 01.在QC实验室进行差距分析，找出有关产品检验方面的缺陷，并在进行工艺转移之前将问题解决。 Perform a GAP analysis in QC laboratory to identify the deficiency related to testing of the products and solve the problems before initiating the technology transfer process. 02.负责起草技术转移材料及产品质量标准。 Responsible for the establishment of technical transfer materials and product quality standards. 03.协助技术转移人员分析待转移的方法并建立稳定性研究的项目。 Assist the transferor to analyze the method transfer and formulate stability rearch program. 04.进行分析方法的对比以及风险分析。 Carry out the comparison and risk analysis of analytical method. 05.负责所涉及的API，赋形剂，中间产品和成品的方法验证或方法转移。Be responsible for the method validation or method transfer of the API, excipient, intermediate products and finished products which involved. 06.提供检测数据及报告（包括稳定性研究）。 Be responsible for performing and providing test data and reports (Stability study included). 07.严格按照转移公司提供的分析方法/方案/报告准备试剂、对照品、易耗品以及进行色谱分析。 In strict accordance with the analytical methods protocol/report provided by the transferring units to prepare reagents, reference substances, chromatography, consumptive material, etc. 08.负责中试项目的检测。Be responsible for the test of the pilot project. 09.进行分析相关的变更、偏差、OOS/OOT 调查及报告（如需）。 Perform change control, deviation and OOS/OOT investigation and report related to analysis (if have). 10.参与讨论解决技术问题。 Involve in the discussion of solutions for the technical problems 11.负责执行分析方法验证/确认并提供方案和报告。 Be responsible for the implementation of analytical method validation / qualification and provide the protocol and report |
仓库Warehou | 01.进行现有存货的差距分析。 Perform GAP analysis of the existing materials stock. 02.通知供应链购买稀缺物料。 Notify supply chain to purcha unavailable materials. 03.保证技术转移过程中物料充足。 Maintain sufficient stock of materials for technology transfer process |
工程部 ENG | 01.参与评估设备适应性。 Participate in asssing the suitability of the equipment. 02.起草及实施技术转移产品改造方案。 Draft and implement the renovation project protocol for the technical transfer product. |
QP | 01.审核及批准技术转移计划、方案及报告。 Review and approve the technology transfer plans, protocols and reports. 02.参与讨论解决技术问题。 Participate in the discussion of solutions for the technical problems. |
技术转移小组 Technology Transfer Team (TTT) | 此项目小组由转移人员负责人以及各部门技术接收人员组成。 The project team consists of the project leader of transferor and the project member from acceptor consisting of different department |
PTD | 生产技术部Production Technology Department |
中试Pilot | 指在产品工艺验证前在生产线按预定的工艺参数进行产品试生产并对相关质量指标进行考察的活动。 Refers to the trial production in the production line in accordance with the predetermined technical parameters and the investigation of relevant quality indicators before PV. |
MoA | 分析方法Method of Analysis |
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