We are YOUR partner for GxP compliance!
GxP is an integral part of all our pharmaceutical & life sciences projects.
We advise you on the introduction of GMP-compliant processes in engineering, production, laboratory, quality assurance and control and assist with customer audits as well as national and international authority audits. Our compliance engineers are always up to date on the latest technology and will support you from the feasibility study to the finished system, on request.
With the help of our integrated Commissioning and Qualification (iC&Q) strategy, we ensure that all customer requirements are taken into account in the project with the required quality right from the start. By planning the commissioning and qualification from the start of the project with synergy effects in mind, we can also implement your project as efficiently as possible in terms of economic and time aspects with the help of our innovative software for risk management REXS.
You can find out more on the REXS website.
In the past there was repeated testing, today there’s integrated commissioning and qualification!
VTU Engineering supports you from the very beginning – we create your qualification and validation concepts, moderate your risk analyses, plan and execute the commissioning & qualification, create necessary SOPs and support you in validating your processes, analysis methods and computerised systems.
We take care of your GMP compliance, over the complete life cycle, all you need to do is choose from our portfolio:
- Planning and developing a customised qualification strategy
- Coordinating and managing your qualification and validation projects
- Preparing qualification and validation documents/master plans
- Carrying out DQ/IQ/OQ/PQ for media and process equipment, package units, COTS and laboratory equipment, filling lines, cleanrooms and HVAC, temperature controlled objects and storage areas, medical devices, automation systems and computerised systems (CSV).
- GxP consulting for both technical and pharmaceutical areas according to ICH Q8, Q9, Q10
- Creating pharmaceutical QM systems, SOPs and site-specific GMP regulations
- Training for your employees in the GxP environment
- Support with internal, national and international authority audits
- Planning and consulting for hospital pharmacies
- Validating methods, manufacturing processes, cleaning and sanitisation measures, GMP-compliant transport of products or intermediates
Our expertise in system design, process characterisation and GMP compliance complement each other to provide the perfect holistic solution for your GMP investment project!