GMP Chart


Brigitte Jarberg

Brigitte Jarberg

Director Pharma, Head of Function Pharma Production
T: +45 5161 6491
Anette Heidi Sebök

Anette Heidi Sebök

Head of Department, Pharma Facility Design
T: +45 51618415

Within the field of pharmaceutical production everything revolves around GMP (Good Manufacturing Practice). The most important element is the safety for the patient, who is the end user of the pharmaceutical product.

Before a facility or a piece of equipment is taken into operation, there is a need for intensive documentation and testing to ensure that everything is in order.

Validation plans (VPL), Design Qualification (DQ), Installation Qualification (IQ), Operation Qualification (OQ) and Process Validation (PQ) are some of the important disciplines that Ramboll is able to perform on the project, thus enabling the client to focus on the production stage.

Ramboll creates the overall plan for the validation activities (VPL) in the initial phase of a project in order to ensure that quality is a priority from the beginning.

One of the most important documents to draw up is the User Requirement Specification (URS), where all requirements are stated.

When the engineers have finished the design of a facility, a HVAC system, a critical utility system or a process system, a design qualification (DQ) is done to ensure that all requirements have been included in the design solution.

During construction, the building process is monitored in order to ensure that the construction is done according to design and that all the needed documents are provided.

When construction is complete and the facility or system is handed over, installations are tested and qualified (IQ). When the installation has been tested (OQ) and approved, the operation and functionality is tested. Often, this has to do with the automation system, (FMS) where Ramboll ensures that the GAMP guideline is followed. Finally, after we have tested and validated the functionality, the process qualification or validation (PQ) is performed in order to ensure that the product can be produced consistently within specifications.

Ramboll can draw up all documents needed for the qualification, based either on the client’s qualification system or on Ramboll own templates.


Visualisation of aseptic cGMP/GMO production facility for Bavarian Nordic

Aseptic cGMP/GMO production facility for Bavarian Nordic

New state of the art aseptic GMO 2 flexible manufacturing facility for manufacture of novel vaccines in Kvistgaard.

Ramboll Group A/S

Ramboll Group A/S
Hannemanns Allé 53
DK-2300 Copenhagen S
Tel: +45 5161 1000
Fax +45 5161 1001


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