Process engineering plants in pharmaceuticals and biochemistry
Qualification of Process Engineering Plants
The qualification of process and procedural engineering plants is an essential component in ensuring product quality, patient safety, and regulatory compliance. We support companies in highly regulated industries with the GMP-compliant qualification of plants, systems, and processes throughout their entire life cycle.
Our services
We take care of the complete or partial qualification of your systems in accordance with applicable regulatory requirements.
- Design Qualification (DQ)
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
- Re-qualification and change management
Projektmanagement
- Planning, management, and documentation of qualification projects
- Coordination of all interfaces involved (engineering, QA, production, suppliers)
- Resource and time management
- Status reporting and risk assessment
Consulting on Standards, Guidelines, and Compliance
- GMP (EU-GMP, Annex 15)
- GAMP 5
- Support during inspections and audits (e.g., FDA, authorities, customers)
