Building an Audit-Ready EM Evidence Package for a New API Dissolution Facility
Qualification and process performance verification of a new Grade C dissolution area at Novo Nordisk Kalundborg. Covering study phase through PFV, with zero missing samples and a fully defensible documentation package built under real operational constraints.
ANNEX 1
GMP Framework
EM
Environmental Monitoring
EU
Delivery Region
Project ongoing
Challenge
Qualifying a New Facility While Managing System Instability and a Complex Evidence Chain
A new dissolution area in classified cleanrooms (Grade C) needed to be qualified and released for handling and production of a specific API. The project covered both an initial study phase and subsequent Process Performance Verification (PFV). Demonstrating that the environment remained in control under realistic and worst-case operating conditions.
Three overlapping challenges made this more than a standard qualification exercise. New facility instability meant that both equipment and IT workflows experienced early reliability issues, yet the EM team still had to secure a complete and defensible evidence chain. Cleaning activities ran through PAS-X, where every product, agent, and cleaning type required acknowledgement from all participants. When the system stopped or entries were missing, GMP evidence was directly affected. During PFV, excursions were governed by alarm and action limits, where a single action-limit event could trigger a major deviation and a larger investigation. The team also had to align operators, sampling staff, and multiple stakeholders with different backgrounds and routines, while remaining firm on documentation and execution discipline throughout.
Solution
Structured EM Specialist Support Across Study Phase and PFV
Damgaard Solutions provided an EM specialist with 20+ years of GMP environmental monitoring experience, embedded within the client's dedicated EM team from before the study phase through PFV completion. The focus throughout was on building a documentation and execution package that would hold up under audit. Not just pass qualification.
1
Robust EM and cleaning documentation
Developed and refined EM templates, protocols, reports, and technical and test sheets in TIMS for both study and PFV phases. Ensuring that what was documented matched what was executed. Updated job and work instructions for cleaning to reflect how the facility actually operated, and ensured PAS-X output could serve as defensible evidence of correct cleaning, correct agents, and participant sign-off. System interruptions were handled through controlled follow-up rather than left as gaps.
2
Hands-on operator and sampler training
Planned and delivered targeted training for operators on gowning, movement in classified areas, correct execution flows, and documentation discipline. Verified training completion before personnel accessed the classified area. Coordinated with the EM sampling team to ensure sampling timing and locations aligned with production activities throughout both phases.
3
Structured deviation and defect handling
When PAS-X issues or documentation gaps occurred, raised defects and deviations, assessed criticality with QA, and drove each item to closure with a clear root cause, defined actions, and acceptance criteria. Involved relevant operators to reconstruct events and arrive at realistic, sustainable solutions.
4
Phase-appropriate escalation discipline
Maintained a clear distinction between the study phase. Where findings were used for characterisation and learning. And PFV, where alarm and action limits governed escalation depth. This protected the integrity of the PFV narrative while ensuring study findings were genuinely used to improve execution before verification began.
Results and Impact
Qualification and PFV supported through the planned reporting flow. Documentation and data packages prepared to support QA review and the release reporting process.
Zero missing samples reported by the team during supported runs, backed by thorough training and close coordination with the sampling team.
Defensible GMP documentation maintained under system constraints. Documentation breaks handled via deviations, classified with QA, and closed with clear root cause and actions, without disrupting the PFV narrative.
Stronger working relationship between EM, QA, and Production, built through consistent coordination across many concurrent parameters and stakeholders.
Environmental monitoring in a new facility qualification is not only a technical exercise. It is a documentation discipline and a team coordination challenge. The value of embedded EM expertise is in connecting systems, procedures, training, and data into one coherent evidence story, with the closure rigour that makes it inspection-ready.
Project Facts
At a glance
Client
Novo Nordisk
Site
Kalundborg, Denmark
Project Duration
2025–
Service Area
Environmental Monitoring (EM)
Scope
Study phase through Process Performance Verification (PFV)
Regulatory Framework
EU GMP ANNEX 1 / ISO 14644
Systems Covered
TIMS, PAS-X, PEMS. Grade C classified cleanrooms
Outcome
Zero missing samples · Audit-ready documentation
Topics
About the specialist
Damgaard Solutions provides Environmental Monitoring specialists with deep GMP experience in classified cleanroom qualification, deviation handling, and audit-ready documentation. Our EM specialists embed within client teams from study phase through PFV. Connecting systems, procedures, training, and data into one coherent qualification story.
To discuss EM project needs or speak with one of our specialists directly, visit our specialists page →
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