Syntegon offers a wide range of services in the field of risk-based qualification and validation of plants, equipment and processes. Our subsidiary Valicare GmbH supports our customers in the GMP-compliant development of clinical trial products.
The team of specialists implements and documents central qualification and validation steps based on comprehensive process and GMP expertise and in compliance with national and international guidelines. Together with our customers, we take the approach to a product that is specified safely and in accordance with the requirements, no matter whether it belongs to the classical class of medicinal products or to advanced therapy medicinal products.
Our service spectrum includes:
- Process risk analyses and process control strategies
We provide iterative risk analyses up to the definition and documentation of the required validation activities and define the parameter corridor (design space) for process control together with our customers.
- Analytics and quality controls
We provide guidance in the selection and definition of analytical methods derived from the process control strategy, prepare test instructions and documentation for verification and validation.
- In-house GMP manufacturing
We provide the required GMP documentation, quality management instructions and binding guidance documents.
- Supplier audits
To ensure the pharmaceutical quality of our suppliers, we carry out graduated qualification measures, where required on a risk basis – from obtaining certificates to on-site supplier audits.
- Pilot plant planning, construction and ready-to-operate installation
We are the one-stop solution for planning, construction, equipment, and ready-to-operate installation of pilot plants, including all necessary qualification and validation services.
- Process transfer to contract manufacturer
We support the search, selection and qualification of a suitable manufacturer.
- ISO 9001-certified GMP service company
- GMP development according to ICH, EU and cGMP Guidelines
- Product- and process-oriented service
- Consulting services and training tailored to individual customer needs
- The cult.tainer concept allows a faster production of ATMPs
Valicare supports customers from the very beginning in deciding which qualification and validation services are best suited to your needs. Please don´t hesitate to contact us!