ATMP

Transforming CGT Facility Design for ATMP Compliance

Pharmalliance Consulting Ltd partnered with a forward-thinking Cell and Gene Therapy (CGT) manufacturer to develop a cGMP-compliant facility in alignment with EU Advanced Therapy Medicinal Products (ATMP) regulations.

This project aimed to build a robust compliance foundation for a cutting-edge therapeutic facility while ensuring operational readiness and regulatory alignment.

The scope of our services included:

Facility Design Support: Collaborating on a cGMP-compliant design tailored to the unique requirements of CGT manufacturing.
Documentation Development: Assisting in generating critical project documentation to support compliance and validation milestones.
Subcontractor Oversight: Providing Subject Matter Expert (SME) supervision to ensure design and build activities met regulatory and quality expectations.
Lifecycle Compliance Guidance: Establishing a lifecycle approach for sustained compliance and operational excellence.
Onsite Supervision: Delivering hands-on support with regular site visits to oversee key activities and resolve emerging challenges.
Engineering and Validation Support: Developing engineering policies, SOPs, and qualification documents to strengthen maintenance, calibration, utilities, validation, and documentation frameworks.

The risks of non-compliance and misaligned facility design could have jeopardized project timelines and regulatory approval.

Pharmalliance’s involvement ensured adherence to EU ATMP standards while streamlining engineering, validation, and quality processes for long-term success.

Bring your advanced therapy manufacturing vision to life.