AUSTAR’s Proven FDA cGMP Expertise: Elevating a High-End Global Pharma’s Three Injection Lines to International Benchmark Status

Project Background

The client, a high-end pharmaceutical enterprise (R&D, production, sales), focuses on globally leading generic and innovative drugs. It has a commercial chemical drug base (meets NMPA/FDA standards) with three injection lines. 

AUSTAR Solution

• AUSTAR provides GMP-compliant validation consulting for the client's peptide drug project lifecycle, including: Gap analysis (core service): Based on FDA cGMP, 7356.002 series, EU GMP Annex 1, and other guidelines (validation is integrated into 6 FDA systems).

• Multi-dimensional diagnosis (document review + on-site assessment) of the client's system, plus targeted rectification suggestions.

AUSTAR Value & Client Benefits

• Leveraging validation consulting expertise, AUSTAR helped the client pass international certifications and boost global competitiveness.

• Together，AUSTAR and the client have established an FDA cGMP-compliant aseptic injection line, setting an industry benchmark.