Advancing HPAPI Production: AUSTAR's End-to-End Solutions for a World-Class Facility

With the continuous advancement of global GMP standards, High-Potency Active Pharmaceutical Ingredients (HPAPIs) are getting significant attention from pharmaceutical companies due to their extensive applications in fields such as oncology and rare diseases. The production of HPAPIs requires a balance of efficiency, safety, and regulatory compliance, posing challenges in facility design, validation management, and risk control.

Project Highlights:

AUSTAR team provided end-to-end consulting services, including feasibility study, construction drawings, and fire protection design to one HPAPI topical formulation production facility renovation project, covering an area of approximately 4,500㎡. This project strictly adheres to FDA, EU GMP, WHO, and EHS standards, aiming to create a world-class production platform for high-potency pharmaceuticals.

Key Challenges:

? Risk assessment and cross-contamination prevention for multi-product production lines.

? Adaptation to varying regulatory requirements across different countries.

? Zoning and isolation of high-potency and non-high-potency areas with airtightness validation.

? Integrated design for process safety, operator workflows, and contamination control.

AUSTAR Value:

? Profound understanding of international GMP regulations (FDA, EMA, NMPA, PIC/S, WHO, etc.)

? Comprehensive containment solutions covering process, equipment, and validation.

? Delivery capabilities for design, construction, and system validation.

? Optimization of costs and risks throughout the project lifecycle.