Everything you need for GMP compliance!
We support you when it comes to developing your standards, installing your GMP-compliant production plant, and establishing your production processes.
Our know-how and project management skills support you in scaling up your laboratory facilities to the commissioning and ongoing operation of large-scale plants in all areas, and particularly for:
- Biotechnological production, both upstream and downstream
- Blood plasma fractionation
- The production of intermediates and pharmaceutical ingredients (including highly active substances)
- Active pharmaceutical ingredients (API), drug substances (DS), drug products (DP)
- Aseptic, sterile and non-sterile production
- Pharmaceutical products (in solid, semi-solid and liquid form), fill & finish operations
- The creation of material for clinical studies
- Research, development and quality control laboratories
- Production which is subject to cosmetics GMP stipulations
- Utility supply operations; heating, ventilation, air conditioning and plumbing; cleanrooms; storage areas
GxP is a key component of all our pharma & life sciences projects.
VTU offers GMP services for qualifying equipment and plants and validating manufacturing processes in the pharmaceutical industry. We provide you with competent advice when it comes to introducing GMP-compliant processes in your laboratory, as well as in the fields of engineering, production, and quality assurance. What’s more, we offer support with customer audits and official inspections.Our expertise in plant planning, process characterization and GMP compliance come together to create the perfect comprehensive solution for your GMP investment project.
Plant and equipment qualification
Creation and moderation of risk analyses, development of tailor-made GMP qualification strategies, creation of master plans, DQ, IQ, OQ, performance qualifications (process & automated recipes, media fills, smoke studies, aseptic work), planning, coordination and handling of all qualification/validation activities, automation systems, computer system validation (CSV).
Inspection management (customers, national authorities, FDA)
Inspection management & logistics, coordinating preparations, identifying hot topics and areas of focus for preparation, quality metrics, document review, pre-inspections, subject matter expert training
GMP-compliant organization and quality assurance
Quality by Design in accordance with ICH Q8, risk management according to ICH Q9, GMP life cycle management according to ICH Q10, creation of pharmaceutical QM systems, creation of SOPs, training of project and company employees
Risk management software
VTU offers an intelligent database solution which enables risk analyses to be managed across projects and even across locations in the form of REXS – Risk Expert System.
Both GMP risk analyses and hazard and operability analyses (HAZOP) are currently being processed across a range of projects.
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