- Overall considerations: Patient safety
- Doing things right
- Ensuring reproducibility
- Ensuring traceability
In product development, the term “quality” is something very defined and specific, which is slightly different than the general concept of quality. Quality can mean both to “do the right things” and to “do things the right way.” In product development, the latter meaning applies. It’s about defining the exact procedures for the various operations to ensure that they “are done correctly and exactly the same way every time,” that is, in a controlled way that can be reproduced in detail. “Traceability” is another keyword in this context, which means that you can retrace every step of the production process and all substances that have been used, in order to clarify where any potential errors might have occurred. All methods and operations are done according to Standard Operational Procedures (SOPs), and all key data are double-checked by at least two people.
Good Manufacturing Practice (GMP) ensures that you get a high quality product which preserves patient safety, the overriding consideration of all drug development.
GMP is to ensure that the product is produced and controlled in accordance with current standards. Basic principles of GMP is that all manufacturing processes are clearly defined, critical steps are validated, and that written instructions are followed. GMP includes both production and quality.
A pharmaceutical quality system must include:
- Products of high quality so that patient safety is ensured.
- Quality of services and products according to customers’ expectations and regulatory requirements.
- Protection of the environment – in terms of preventing pollution.
- Health and welfare – for staff and surroundings.
A pharmaceutical quality system should improve:
- Continuous improvement of the quality and efficiency of processes, services and products.
- Regular monitoring and assessment of the production effectiveness.
- Through the network Life Science Pilot, Catapult Life Science will contribute to skills development in quality, and if desired, also be able to arrange courses in this field for our members. For more info, see “Life Science Pilot.”