Audit

Safeguarding Aseptic Excellence for a U.S. Pharma Leader

Pharmalliance Consulting Ltd collaborated with a leading U.S.-based pharmaceutical manufacturer to address critical compliance challenges within their aseptic building operations.

This high-stakes project aimed to enhance operational efficiency and align processes with stringent regulatory standards.

Our contributions included:

Engineering Program Evaluation: Leveraging proprietary risk assessment tools to identify high-level risks within the site’s engineering program and provide targeted improvement strategies.
Preventive Maintenance Optimization: Conducting a high-level review of PM programs for major unit operations, including fillers, autoclaves, and depyrogenation ovens, delivering actionable recommendations to optimize compliance and efficiency.
HVAC and Clean Utility Assessment: Performing a detailed analysis of HVAC and utility systems, including deviations, alarm setpoints, trend data, and P&IDs, complemented by walkthroughs of critical systems such as PW, WFI, and clean steam utilities.

The stakes were high: Non-compliance risks threatened regulatory approval, operational continuity, and patient safety.

Pharmalliance’s detailed approach uncovered compliance gaps and provided practical, regulatory-aligned solutions, ensuring the client met EU Annex 1 and FDA guidelines.

Are compliance challenges putting your operations at risk?