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Global Enterprise Compliance Consulting Services

The company was founded in 1849 and has a history of over 170 years. It is committed to leveraging science and global resources to improve health at every stage of life. In the exploration, development, and production of pharmaceuticals, it strives to set standards for quality, safety, and value. Its diverse global healthcare portfolio includes biologics, small molecule medicines, and vaccines, along with many world-renowned health products. As one of the world's top ten pharmaceutical enterprises, it operates multiple production facilities in China. Since 2014, AUSTAR group has provided premium compliance validation services to a Wuxi-based facility specializing in sterile lyophilized anti-tumor preparations.

AUSTAR Solution

Leveraging deep understanding and rich experience in pharmaceutical process technology and team execution capabilities, AUSTAR delivered: - High-Containment Weighing and Dispensing Isolators - C&Q Validation Consulting Services - Integrated Validation for Lyophilization-Filling Lines - Cleanroom Air Recovery Testing Consulting

Highlights

AUSTAR leverages profound pharmaceutical process expertise and professional execution to provide top global pharma firms with key services (e.g., high-containment weighing/batching isolators, C&Q validation consulting), helping the project meet GMP/PMDA requirements of China, the US, the EU and Japan.

AUSTAR Value & Client Benefits

The project achieved compliance with China GMP, US cGMP (21 CFR 210-211), EU GMP (Eudralex Vol. 4), and Japan PMDA standards. The high-containment isolator passed SMEPAC (Sterile Manufacturing Equipment Performance Acceptance Criteria) testing by US HPC Inc. with exemplary data, fully meeting OEB5 (Occupational Exposure Band 5) requirements.
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