CDMO GMP Compliance Audit for Aseptic Biologics
Case Overview
GMP Compliance Audit for Aseptic mAb & ADC Manufacturing
A CDMO specializing in aseptic processing of monoclonal antibodies (mAbs) and Antibody–Drug Conjugates (ADCs) required a comprehensive compliance assessment. Our audit covered media fill validation, environmental monitoring programs, and cleaning validation for multipurpose ADC equipment. The engagement concluded with a formal EU QP GMP Audit Report, qualifying the facility for both clinical and commercial-grade sterile production.
- Service Type: Auditing (Consultancy Activity)
- Regulatory Alignment: Eudralex Vol 4 and Annexes; PIC/S
