It is the responsibility of quality assurance professionals to develop, monitor and oversee processes that assure control in manufacturing in the pharmaceutical, food, cosmetics, and other life-science industries. Increasingly, the concept referred to as Quality by Design (QbD) is becoming a necessary one to understand for professionals working in quality assurance.
According to the American Association of Pharmaceutical Scientists Journal, Dr. Joseph M. Juran first published on the early development of QbD in the early 1990’s. Since then the ideas behind the QbD approach have been developed further and different industries are still considering how to implement them.
While QbD may sound self-explanatory, here are a few ways to understand and apply the concept.
What is Quality by Design Exactly?
QbD begins with known objectives and focuses on understanding the product as it is designed, which means using a science-based approach to monitor the processes involved in making the product. The key idea is that quality controls are part of the design of the manufacturing process from the beginning.
The first stage of QbD is establishing a quality target product profile. What is the intended use and how will consumers use it? Then the Critical Quality Attributes (CQAs) must be defined. In pharmaceutical development these are the physical, chemical, biological, or microbiological properties that affect the product’s purity, strength, how it is released and its stability. Following the definition of CQAs a risk assessment is performed. Finally a control strategy is then designed and this will include the management of the product so it can be continually improved.
After you complete your quality assurance courses, you may enter the professional world where it will be your responsibility to make sure companies meet government requirements. The more you know about different approaches to quality control, such as QbD, the better.
Why Do You Need to Know About QbD for Quality Assurance Training?
In 2016 Health Canada announced the adoption of the International Conference on Harmonisation (ICH) guidance document for pharmaceutical development, which includes the QbD approach. This does not mean implementation of QbD or the other things recommended by the ICH working group are required, but that a government body endorses them.
Within this guidance document it is noted that a QbD approach has the potential to enhance the quality of a product. For regulators, QbD will help them better understand strategies that companies implement in their development processes.
The adoption of this document shows that throughout and beyond your quality assurance training it is likely you will have to adapt and update your knowledge constantly as industry and regulatory standards change.
The QbD Approach Compared to the Minimal Approach
QbD is a systematic approach that involves experiments and using process analytical technology (PAT) and tests to identify CQAs as well as risk assessments. These all inform the design of quality control.
In a manufacturing process involving pharmaceuticals, a minimal approach is a fixed approach. Validation of the product is based on initial full-scale batches and the focus is on optimization and reproducibility. QbD, on the other hand, is adjustable. Validation is a continuous process and the focus is on control strategies, where statistical process control methods are used.
Although the focus here has been on pharmaceuticals, the knowledge gained in quality control courses and an understanding of QbD can be applied to other life-science industries as well.
Interested in taking quality control courses?
Contact the Toronto Institute of Pharmaceutical Technology for more information.