Patient safety is the primary concern in all product development for health and medicine. Therefore, to ensure complete control of what the patient is exposed to, the term “quality” means something clearly defined and specific in pharmaceutical product development.
At Catapult we want to assist our clients and customers both in “doing the right things” and in “doing things right”, but the concept of quality in product development focuses on the latter meaning. It is about defining exact procedures for the various operations to ensure that they are “done correctly and completely every time”, that is, in a controlled manner that can be reproduced in detail. “Traceability” is another keyword in this context, that is, one can find back everything that has been done and all the substances that have been used, in order to clarify where any errors may have occurred.
Therefore, in our production department and QC-lab, we work according to a pharmaceutical quality system that has been inspected by the Norwegian Medicines Agency. All methods and operations are performed according to written procedures (Standard Operational Procedures, SOPs), and all key data are double checked by at least two persons.
The overall concern in all drug development is, as mentioned, the patient’s safety. Good Manufacturing Practice (GMP) will ensure that you get a product of the right quality so that the patient’s safety is ensured. GMP shall secure that the product is manufactured and controlled in accordance with the current regulatory standards. The basic principles of GMP are that all production processes are clearly defined, critical steps are validated, and that all work is carried out according to written instructions. GMP includes both production and quality control. The GMP activity’s pharmaceutical quality system must ensure:
- Products of the right quality to ensure patient safety
- Quality of services and products according to customers’ expectations and regulatory requirements
- Environmental protection – to prevent pollution
- Health and welfare – for employees and surroundings
The pharmaceutical quality system should contribute to:
- Continuous improvement of the quality and efficiency of processes, services and products
- Regular monitoring and assessment of efficiency
Through the network Life Science Pilot, Catapult Life Science will contribute to competence development in Quality, and we are planning courses in this field under the auspices of the network, see www.LSPilot.no.