T&W’s sales and marketing personnel conduct preliminary discussions with customers on potential projects. This discussion usually takes place after the signing of a confidentiality agreement (CDA). The two parties will exchange some information related to the project and agree on the scope and progress of the project. On this basis, the two parties will continue to work hard to ensure that the client project successfully executed.
Our sales and marketing personnel will provide customers with information about our services and capabilities, and in the process obtain a general understanding of customer requirements. In the early stage of this process, we will assign a project manager to be responsible for technical negotiation with the customer with the necessary support from various relevant departments, so as to reach a final customized agreement with our customer.
Once the agreement was reached, a project team composed of personnel from various departments led by the project team leader was formed. The project team includes personnel from various functional departments, including sales, research and development, production, QA/QC, procurement, and other departments necessary to ensure the success of the project.
The project manager is usually the key contact of the customer in T&W Group. The project manager will keep the customer informed of a series of progress from the start to completion of the project. Its main purpose is to ensure that the project can progress according to the corresponding time and budget and meet the quality standards expected by the client.
遐瑞的销售和市场人员就潜在的项目和客户进行初步的探讨。这种讨论通常是在签定一个保密协议(CDA)后进行,双方会交换一些与项目有关的信息并就项目的范围和进度达成一致意见,双方会在此基础上不断努力以确保客户项目的成功执行。
在开始确定潜在危害的设施和制造流程之前,所有生产和开发场所均应进行详细的安全审核和风险评估。
将投入大量资金建设废物处理设施。我们鼓励发展环保项目,以减少能源消耗和高科技污染。我们实施清洁生产战略,以实现可持续发展。
安装冷凝器和净化器以排放蒸汽和气体。
所有现场废水在离开现场之前都会进行废水处理。
Prior to the start of our facilities and manufacturing processes that identify potential hazards, all production and development sites have a detailed safety audit and risk assessment.
Large investment will be made to build a waste treatment facility. We encourage the development of environmental protection projects to reduce energy consumption and pollution with high technology. We implement strategies for cleaner production to achieve sustainable development.
The condenser and the purifier are installed to emit steam and gas.
All onsite wastewater flows wastewater treatment before leaving the site.
Process hazard analysis
Develop procedures
Develop emergency response procedures
Sound personal protection
Regular health check
Pollution Prevention
Reduce or prevent solid and hazardous waste
Recycling and assessment of garbage and reuse
Non-process waste recycling related
Recognize and understand customer needs, develop systems and processes to meet customer needs, and always focus on customers.
Implement quality requirements throughout the product's life cycle, and follow cGMP and industry standards set by regulatory agencies.
Discover and correct system deficiencies, continuously improve and improve, and constantly strive for excellence.
Customer first, quality-oriented, continuous improvement and the pursuit of excellence.
T&W's quality management system is synchronized with international standards. It is a quality management system based on FDA QMS as the guiding principle, ISO9001 as the basis, ICH as the guide, 21CFR and China GMP as the basis.
Quality Activities and Workflows-Creating Product Quality in the Process
In T&W, product quality is achieved through layer-by-layer quality assurance starting from raw materials, which includes testing and release of raw materials, review and approval of master batch records, issue of batch records, supervision of batch record execution, QC Intermediate control and intermediate testing, review of batch records, product release, pre-shipment inspection and sample delivery, shipment tracking, etc. Quality activities run through the entire life cycle of a product.
T&W believes that product quality is not obtained through testing, but through quality assurance activities in the entire supply chain, including product process design, production, and sales. The FDA also explicitly proposed this concept in its guidelines for the construction of industry quality systems.
T&W定制团队由技术娴熟,进取和经验丰富的员工组成,他们是工艺开发和生产的专家。我们致力于为制药,农业和特种化学行业的客户提供创新的产品和服务。
T&W的优势:
从中小型到商业化生产都有丰富的经验。
该项目是根据计划和预算执行的,并与客户及时沟通。
质量体系和EHS符合国际惯例。
严格支持知识产权保护政策。
符合cGMP,FDA审计、DMF、EDMF或COS文件支持。
认知和了解客户需求,发展体系与流程满足客户需求,永远以客户为核心。
在产品的整个生命周期内贯彻质量要求,遵循法规部门制定的的cGMP和行业标准。
发现和纠正系统不足,持续改进提高,不断追求卓越品质。
客户优先,质量为本,持续改进,追求卓越。
遐瑞的质量管理体系与国际标准同步,以FDA QMS为指导原则、以ISO9001 为基础、以ICH为指南、以21CFR、中国GMP为依据建立的质量管理体系。
在遐瑞,产品的质量是通过从原料开始的层层质量保证来实现的,它包括对原料的测试与释放,主批记录的审核批准,执行批记录的发放,批记录执行的监督,QC中间控制及中间体的测试,批记录的审核,产品的释放,发货前检查及送样,发货跟踪等等。 质量活动贯穿于产品的整个生命周期。
遐瑞人相信,产品质量不是通过检测得到的,而是通过对产品工艺设计、生产、销售等整个供应链各环节的质量保证活动来获得的。FDA在对行业质量体系建设的指南中也明确提出了这个概念。