GMP consulting / GMP helpline

We help you to define the critical GMP requirements and support you in the course of the project to ensure their implementation. The URS (User Requirements Specification), the design review and the traceability matrix serve as important tools here. The URS serve as input into the planning, while the design review (often with several runs) checks the extent to which the GMP requirements have been taken into account in the planning. The traceability matrix allows you to keep track of everything.

GMP laboratories in hospitals (esp. Cytostatic production, ATMP production and sterile production in general) form our main area of expertise.

• In terms of construction project management, it is important to integrate the URS and GMP requirements into the overall project from the very beginning. For our service, this means:
• Early workshops on GMP requirements with user and architect
• Cleanliness class plan, differential pressure plan, personnel routes and material routes (logistics) should also be drawn up at an early stage so that all project participants know the project basics
• Integrating and coordinating way of working between all project participants
• GMP requirements must be understood by all those involved in the project, especially the specialist planners and finally the executing trades, i.e., they must be explained to them unhurriedly.
• Any questions that arise must be clarified promptly.
• A final design review is needed to ensure that the tender documents contain the GMP requirements.
• This, of course, is followed by the design qualification (in some cases it is a good idea to carry out the final design review as a design qualification), installation qualification, functional qualification and performance qualification.

Write us an e-mail to schedule a meeting and to discuss your project needs. We will get in touch with you shortly.

In principle, you can commission our GMP consulting on an hourly basis (with timesheet and cost cap), so that you have the necessary cost certainty and flexibility to adjust the scope of services at short notice.

What should be done if the GMP project has advanced already? (GMP helpline)

Sometimes it happens that the topics of GMP and qualification are raised quite late in the course of the project. In these cases, it is important - with regard to the qualification process and the manufacturing license - to create the necessary documents retrospectively and to review the current planning status as soon as possible with regard to GMP requirements and, if necessary, to correct the planning.

Experience has shown that it is possible to ultimately achieve a good result even with planners who are still comparatively new to GMP.

Write us an e-mail to schedule a meeting and to discuss your project needs. We will get in touch with you shortly. If you need a very quick response, please call us in addition to your e-mail: +49 (0) 9174 9765527.