Contamination Control

Pharmalliance Consulting Ltd collaborated with a major biopharmaceutical company to revitalize their Contamination Control Strategy (CCS) amidst FDA scrutiny.

This high-stakes project aimed to ensure compliance for a drug substance process while addressing regulatory concerns.

The scope of work included:

• CCS Analysis: Comprehensive review of existing documentation, alignment of the briefing pack with FDA expectations, and gap analysis based on FDA feedback.

• CIP/SIP Strategy Evaluation: Detailed assessment of current Clean-in-Place (CIP) and Sterilization-in-Place (SIP) procedures to pinpoint inefficiencies and align with industry best practices.

• Contamination Control Strategy Updates: Development of updated CCS documentation with clear justifications grounded in regulatory standards.

• FDA Response Document: Creation of a targeted response to address all FDA queries succinctly and effectively.

The risk of non-compliance posed serious implications: delayed approvals, potential financial losses, and reputational damage. 

Pharmalliance’s interventions ensured the company’s CCS not only met but exceeded regulatory expectations, fortifying their position for FDA approval​.

Facing challenges in contamination control or regulatory compliance? 

Contact us today to ensure your compliance and operational excellence.