BIOREACTOR SYSTEM ANALYSIS

BIOREACTOR SYSTEM ANALYSIS

We provide comprehensive bioreactor system analysis services to ensure regulatory compliance, operational robustness, and validated performance within GMP-regulated environments.

Our scope includes: 

  • Initial Risk Assessment, including GAMP categorization and ERES applicability evaluation

  • Quality Risk Assessment (QRA) specific to bioreactor systems

  • Preparation and review of Design Qualification (DQ) protocols

  • Leveraging assessment documentation to support Installation Qualification (IQ) and Operational Qualification (OQ), aligned with Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) outcomes

  • Preparation and review of vendor IQ/OQ protocols, including development of cover protocols where required

  • Execution and review of Installation and Operational Qualification (IOQ) activities

  • Preparation of Performance Qualification (PQ) protocols

  • Compilation of Quality Summary Reports (QSR)

Our structured, risk-based approach ensures that bioreactor systems are properly designed, installed, tested, and verified to meet GMP, data integrity, and process performance requirements.