Compliance & Validation Services for Vaccine Leaders

Project Background:

As a leading innovator in vaccine R&D, the client specializes in the development, production, and commercialization of innovative, high-quality, and affordable human vaccines. The client possesses globally innovative technology platforms and holds multiple core intellectual property rights and proprietary technologies for vaccines. Additionally, it collaborates with numerous global research institutions on cutting-edge R&D.

The company has established a large-scale, modern vaccine production base in China, designed, constructed, and operated in compliance with international standards, enabling the supply of multiple novel vaccine products. Additionally, it has set up local production lines in several countries to accelerate global vaccine coverage. To meet international business requirements, the client requires revalidation of equipment and facilities in the production workshop prior to Process Performance Qualification (PPQ), ensuring compliance with regulatory audits and production needs.

AUSTAR Solution:

• Pre-C&Q consulting, including Validation Master Plan (VMP) and Qualification Summary Report (QSR)

• Facility qualification and validation services

• Process equipment qualification and validation services

AUSTAR Value & Client Benefits:

The project complies with international standards such as NMPA GMP, WHO GMP, EU GMP, and FDA cGMP, providing a solid foundation for the client's global market access.

AUSTAR has been deeply involved in the project and has reviewed relevant validation documents. Leveraging extensive experience and a professional team, AUSTAR earned high recognition from the client by delivering high-quality solutions, reports, and execution efforts. This ensured the rapid and high-standard completion of the project.

AUSTAR and the client have collaborated multiple times, fostering mutual team growth during the project and laying a strong foundation for future continuous cooperation.