Late-stage qualification, PPV PL1 closed on time.
Joining shortly before qualification, Damgaard Solutions ran EM execution, PEMS trend analysis, and contamination source investigation in the Grade D dissolution area at Novo Nordisk Kalundborg, closing PPV PL1 on time and GMP compliant.
Closing a Late-Stage Qualification Under System and Coordination Risk
A new dissolution area in Grade D classified cleanrooms in PPV PL1 needed to be qualified and released for manual API handling. The work covered an initial study phase and subsequent Process Performance Verification (PFV), demonstrating that the environment stayed in control under realistic operating conditions.
Several overlapping challenges made this more than a standard qualification. Securing approval for the rooms to be qualified was the central hurdle. PAS-X introduced complex system integration, validation, and user acceptance issues. The HVAC system had to be adapted to meet strict environmental and quality requirements, which called for cross-disciplinary coordination. EM excursions had to be investigated and closed, and operators needed training in cleaning and product handling to protect product quality. The specialist also joined shortly before qualification, so ramp-up had to be fast and the documentation had to stay defensible throughout.
Embedded EM and PFV Execution From Study Phase Through Release
Damgaard Solutions provided an Environmental Monitoring specialist embedded in the Dissolution area team in PPV PL1, from before the study phase through PFV completion. The focus was practical execution and audit-ready documentation, delivered in close coordination with operators, QA, and the EM team.
1. EM execution, trend analysis, and excursion investigation
Managed environmental monitoring across study and PFV, including data analysis, trend reporting in PEMS, and investigation of EM excursions. Used CCTV review and microbiological screening to identify contamination sources and support corrective actions.
2. Validation documentation and cleaning rationale in TIMS
Prepared facilities, equipment, and documentation for study and PFV, including test plans, validation reports, and execution in TIMS. Reviewed and optimized cleaning rationales to ensure both compliance and efficiency.
3. GMP compliance and structured deviation handling
Performed room inspections, cleaning verification, and deviation handling. Monitored HVAC and EM data and drove excursions to closure with QA, keeping records traceable and documentation defensible throughout study and PFV.
4. Operator training and cross-functional coordination
Trained operators in cleaning procedures and documentation standards. Ran daily status meetings and visual board sessions with EM and operator teams, and proactively coordinated external partners for facility services, repairs, and equipment fabrication to avoid delays.