Quality is key
The key to our success is a quality–centred culture at every level from development to production and logistics.
Our quality system is dedicated exclusively to the pharmaceutical sector. We work together to provide you with customized quality documents and reports, allowing you to register your pharmaceutical product.
By means of a quality agreement, we can define specific requirements regarding the quality of our products and the roles and responsibilities of HDB and our clients. By enhancing our quality management system we ensure you of the best possible quality.
Exceptional production standards
Our cutting-edge manufacturing facility provides you with quality, capacity, flexibility, efficiency and assured supply.
With our certified quality management system we guarantee products which meet the highest industry standards:
- ISO 9001:2015 (Quality management systems – Requirements)
- EN ISO 13485:2016 (Medical devices)
- ISO 15378:2017 (Primary packaging materials for medicinal products)
- Directive 93/42/EEC (Medical Device Directive)
- DMF available for dosing applicators for human use
- Registered FDA facility
- Regulation (EU) 2017/745 (Medical Device Regulation)
- ISO 14001:2015 (Environmental management system)
To make sure all employees work according to our quality management system, we provide them with training on regular basis. Every single process step has a built-in quality control which starts with analysis of incoming materials.
Our production processes are monitored by the production operators through in-process controls (IPC) including visual, dimensional and functional inspection.
On top of that, our Quality Control team checks that we comply with customer specifications, to ensure that all our products are of excellent quality. They perform a recheck of all IPC's and carry out additional tests, as agreed with the customer:
- Leak testing
- Specific measuring
- Drop rate tests
- …
We have two cleanrooms that have a combined surface of 3888 m². Both human and veterinary applications can be produced in our cleanrooms (class ISO 5 or ISO 7).
Because at HDB, excellence is not an act. It’s a habit.
