Quality

Our teams in Zhejiang Tianyuan Bio-Pharmaceutical Co., Ltd. are well structured in order to guarantee a sound research and development, a production conform quality and GMP standards, as well as a professional product quality assurance and control.

We are constantly striving for continuous quality improvement. GxP has been introduced at a high level of performance. This process is still going on, to guarantee the quality and effectiveness of our products now and in the future. GxP is a quality system which has to be practiced to maintain and to assure the quality of all processes in and outside the company.

The processes take place in regulated environments and must satisfy to strict quality requirements, imposed by the Chinese law and also by international institutions, as the WHO, American and European authorities. It is the intention of Zhejiang Tianyuan Bio-Pharmaceutical Co., Ltd. to meet the international standards.

Product Safety

The focus of our company is to produce high quality vaccines conform GMP guidelines and pharmacopoeial quality regulations.
High product quality, safety and efficacy are ensured via the following principles:

• use of characterized and homogenous starting materials of well-defined origin and conform with quality standards
• consistent production in a qualified clean room environment with qualified equipment and validated production processes, that guarantee reproducibility and consistency between batches
• well-trained personnel in production, engineering, QC/QA, that ensure the quality on the spot and adhere to Standard Operation Procedures
• use of a documentation system, that allows traceability and trend analysis
• in-process controls and quality control of final products, that monitor and restrict the use and distribution of qualified products only
• release of products by our internal quality assurance and also by China's Food and Drug Administration
• anti-counterfeit label, that allows the customer to trace back the authenticity of our products
• functioning recall system, that ensures customer safety in case of concern