AUSTAR Compliance Consulting Service Wins a Global Pioneering Recombinant Human Albumin Manufacturer Contract

AUSTAR Compliance Consulting Service has won a service contract with a global pioneering recombinant human albumin manufacturer to provide validation consulting services for its phase I recombinant human albumin production base project.

The new project is for a global biopharmaceutical company, which has a focus on the industrialization development and large-scale production of the Class I novel drug—Recombinant Human Albumin Injection in China. Its global pioneering recombinant human albumin has recently been approved for marketing by the Eurasian Economic Union - Ministry of Health of the Russian Federation. Moreover, the client has established strategic partnerships with multiple countries and plans to apply for rapid clinical trials in the US.

Our services and benefits

AUSTAR technical team will provide high-standard compliance consulting services for the project that complies with NMPA、EU、FDA and PIC/S GMP.

• NMPA, EU, FDA, and PIC/S GMP compliant qualification and validation will guarantee successful completion acceptance and trial production.

• Computerized system (including LIMS system in QC laboratory) validation based on ISPE GAMP 5 (second edition) will ensure its stability, reliability, and regulatory compliance, achieving effective support for the client’s key business processes.

• Customized quality system audits and special subject training will improve the maturity of the quality management system, effectively control quality management risk, and lay the foundation for product internationalization.

Through customer-oriented compliance consulting services, AUSTAR will establish an effective pharmaceutical quality system (PQS) for the client to help achieve breakthroughs in innovation.