dcsimg GMP - Ramboll Group
      
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GMP

 
 

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.

GMP chart

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.

Contact

Anna Lise Sørensen
Anna Lise Sørensen
Head of Department, Pharma Production
T+45 5161 5334
Eanls@ramboll.dk
Anette Heidi Sebök
Anette Heidi Sebök
Head of Department, Pharma Facility Design
T+45 51618415
Eahis@ramboll.dk