GMP Services
From Engineering Services
We support you in developing your standards, in setting up your GMP-compliant production facilities and in establishing the manufacturing processes.
Details:
Our knowledge and project management will accompany you from the scale-up of laboratory plants, to the commissioning and ongoing operation of the large plant in all areas, especially for:
- Biotechnology productions upstream and downstream
- Blood plasma fractioning
- Intermediate and active ingredient productions (also for highly active substances)
- Active Pharmaceutical Ingredients (API), Drug Substance (DS), Drug Products (DP)
- Aseptic, sterile and non-sterile productions
- Pharmaceutical products (solids, semi-solids and liquid forms), Fill&Finish
- Manufacture of material for clinical studies
- Research, development and quality control laboratories
- Productions under cosmetic GMP conditions
- Utility supplies, HVAC / HKLS, clean rooms, storage areas, technical areas, solvent recovery
GxP is an integral component of all our pharmaceuticals & life science projects.
VTU offers GMP services in the scope of qualification of plants, and validation of manufacturing processes in the pharmaceutical industry, consulting on the introduction of GMP compliant processes in engineering, production, laboratory and quality assurance, right up to management of customer audits and authority inspections.
VTU offers GMP services in the scope of qualification of plants, and validation of manufacturing processes in the pharmaceutical industry, consulting on the introduction of GMP compliant processes in engineering, production, laboratory and quality assurance, right up to management of customer audits and authority inspections.
Expertise in plant design, process development and in GMP compliance complement each other to become an optimum overall 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 Qualification (Process & automated recipes, media fill, smoke studies, aseptic work), planning, coordination and handling of all qualification / validation activities, automation system, computer qualification, computer validation
Inspection management (customers, national authorities, FDA)
Inspection management & logistics, coordination of preparation, identification of hot topics and preparation focuses, quality metrics, document review, pre-inspections, subject matter expert training
GMP compliant organisation 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 operating employees
Software for risk management
With REXS - Risk Expert System, VTU offers an intelligent database solution, which enables cross location management of risk analyses.
Creation and moderation of risk analyses, development of tailor made GMP qualification strategies, creation of master plans, DQ, IQ, OQ, Performance Qualification (Process & automated recipes, media fill, smoke studies, aseptic work), planning, coordination and handling of all qualification / validation activities, automation system, computer qualification, computer validation
Inspection management (customers, national authorities, FDA)
Inspection management & logistics, coordination of preparation, identification of hot topics and preparation focuses, quality metrics, document review, pre-inspections, subject matter expert training
GMP compliant organisation 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 operating employees
Software for risk management
With REXS - Risk Expert System, VTU offers an intelligent database solution, which enables cross location management of risk analyses.
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