qualification of GMP Laboratories

What do you expect of your service provider: reliable standard concepts or tailor-made special solutions?

 

As your demands can probably not be satisfied with standard concepts, we customize concepts proved and tested as successful to your specific situation according to your technical system, your processes, plants, requirements on your products and in line with your organisational structures as well as the planned project scope. We put special emphasis on keying in the total complexity in clear and understandable documents and integrate your personnel in all qualification and validation operations. Thereby you lay the foundation for the sustainability and adaptability of your operations to new tasks and changing, extern conditions. Thus you succeed in using your plant for new products, putting new procedures to the test and expanding the capacities of your plant, without having to repeat all qualification and validation operations.

Our qualification services

 

Our service for the qualification of GMP laboratories covers the entire qualification process. We consult on defining URS (user requirements specification), support you in carrying out impact and risk analyses and, depending on the mission, create further documents such as the VMP (validation master plan). Your specific requirements will be implemented on a project-specific basis. Subsequently, we carry out the qualification phases DQ (design qualification), IQ (installation qualification), OQ (operation qualification) and PQ (performance qualification) and prepare a final report.

 

 

 

We offer our qualification services for the following systems in particular:

 

  • GMP laboratories for the production of ATMPs (advanced therapy medicinal products)
  • GMP laboratories for cytostatics production in hospitals
  • Blood banks
  • Hospital pharmacies

 

Feel free to contact us to coordinate your project requirements with us.