From Installed to PQ-Ready. Closing the Gap on a Filling Line Washer
A filling line washer at HAA Gentofte was installed but not ready for performance qualification. Documentation was incomplete, calibration status was unresolved, and open technical points risked delaying handover. Damgaard Solutions was brought in to close every gap and deliver a machine the line could own with confidence.
ANNEX 1
GMP Framework
W+S
PQ Readiness
EU
Delivery Region
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Challenge
An Installed Machine That Was Not Yet a Qualified One
The washer had been installed as part of a larger fill-finish setup at HAA Gentofte, but installation and readiness for performance qualification (PQ) are not the same thing. Parts of the documentation and service instructions were incomplete or inconsistent. Calibration status needed to be verified and aligned with the qualification strategy. Open technical points remained unresolved. The operations organisation needed more than a machine that ran. They needed one they could hand over, maintain, and stand behind in an inspection.
Solution
End-to-End Closure of All Pre-PQ Open Points
Damgaard Solutions assigned Peter Mastrup as Lead and Technical Specialist on the washer, with a mandate to define what "ready for PQ" meant in concrete terms and close everything standing between the installed state and that standard.
1
Scope and expectation alignment
Established shared understanding between the project organisation, vendor, and end users on what PQ-readiness required in practice. Ensuring no ambiguity about acceptance criteria before the closure work began.
2
Systematic documentation review
Reviewed manuals, certificates, test reports, and change records to confirm the material was sufficient and usable for both qualification and future inspections. Gaps were identified and resolved rather than carried forward.
3
Calibration and test verification
Verified that critical instruments were correctly calibrated, that results were documented, and that all open calibration and test points were formally closed before PQ commenced.
4
Technical troubleshooting and vendor dialogue
Resolved remaining technical issues in direct dialogue with the vendor, keeping the focus on robust function rather than minimum formal compliance.
5
Handover preparation
Ensured that service instructions and essential operational knowledge were in place so the line could take ownership of the equipment from day one, without encountering unresolved issues after handover.
Results and Impact
The washer reached a clearly defined and fully documented PQ-ready state.
Handed over with structured documentation, verified calibration status, and complete service instructions.
The operations organisation gained confidence in both machine performance and maintainability from the first day of ownership.
The project illustrates the difference between a machine that has been installed and one that is genuinely ready for the people who will run and maintain it. Getting that right before PQ is faster and less disruptive than discovering gaps during it.
Project Facts
At a glance
Client
Novo Nordisk
Site
HAA Gentofte, Denmark
Project Duration
June 2024–January 2025
Service Area
Washing and Sterilization (W+S)
Scope
Pre-PQ gap closure through handover
Regulatory Framework
EU GMP ANNEX 1
Systems Covered
Filling line washer
Outcome
PQ-ready state achieved and documented
Topics
About the specialist
Peter Mastrup is a Senior Engineer at Damgaard Solutions with 25 years of hands-on experience with washers, autoclaves, and CIP/SIP systems in pharmaceutical environments. When he takes the lead on a piece of equipment, his focus is on qualification, documentation, and real-world use. So clients are left with solutions that are easier to own, maintain, and qualify over the long term.
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