QVA & GMP compliance
Our services in the field of QVA:
Qualification concepts
Risk analyses, GAP analyses
IQ / OQ / PQ
Media systems (water systems, HVAC, clean rooms)
Qualification and validation of process plants (cycle development, temperature distribution studies)
Process validation
Cleaning validation
With our knowledge of current international GMP regulations and relevant industry standards, we support the development of qualification and validation strategies, advise on current regulatory guidelines, provide a complete documentation package, and help to successfully pass inspections and audits.
To guarantee GMP compliance in all functions and phases, we offer our customers consulting services throughout the entire product life cycle. We understand how to tailor our consulting activities also to small and medium-sized companies – without compromising quality.
Our specialists in GMP compliance provide support in the GxP requirements of FDA, EU, ICH, and PIC:
- Audit and inspection preparations
- Training on GxP topics
- Support for risk management
- GAP analyses
- Creation of qualification and validation concepts
- Introduction or optimization of quality management systems
- Process validation
