Discover how Quality by Design (QbD) principles can enhance drug development processes, ensure regulatory compliance, and improve product quality.
Quality by Design and How Pharmaceutical industry is Positioned for More Efficient Drug Development & Regulatory Success in Life Sciences
In the field of life science industry, efforts have been made to discover new medications, which is one of the most beneficial but difficult aspects. Taking a pharmaceutical molecule from the concept through to its market-ready product is intricate and resource consuming which requires accuracy, efficiency, but most of all quality. This is where the principle of “Quality by Design” (QbD) becomes a guiding philosophy. QbD not only ensures the development of high-quality drugs but also helps in accelerating regulatory pathways.
Quality by Design (QbD) Essence
A systematic quality by design (QbD) philosophy that is science-based focuses on the development of a drug effect relationship with respect to formulations and understandability of product manufacturing processes, which in turn helps in developing a high-quality endpoint pharmaceutical product.
Propagated by regulatory agencies like U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA), the concept involves predetermined quality attributes and prioritisation of critical parameters during the journey of drug development.
QbD has its core principles which consist of:
Objective: to unequivocally define the therapeutic objectives and intended use of the drug product.
Design of Experiments (DoE): It is the application of scientific methods to establish the relationship between different input variables and their effect on the quality characteristics of the product.
Risk Assessment: Identify risks related to the manufacturing process and eliminate them through pre-emptive actions.
To ensure continued adherence to established quality criteria, monitor in real time using various kinds of monitoring and control systems.
Continuous Improvement: Refinement of the drug development process based on real-world insights.
Why Design Is the Right Approach for You?
1. Enhanced Product Quality
Quality not only one of the desired characteristics but it is mandatory when we talk about pharmaceutical industry. Quality is the most important part of drug development in design-centric approach. The more a pharmaceutical manufacturer understands the inter-relationship between raw materials, process parameters and product attributes, the higher level of quality control they can maintain across their products. This is not only great from a patient safety standpoint, but it is also good at rounding out a company’s story.
2. Development is Less Cumbersome
QbD provides a systematic approach that involves identifying risks and challenges as early as possible. That in turn, translates to less chances of unforeseen hiccups and expensive time wastages. This way, they will be able to find a way to invest resources properly, minimize wastage and thus achieve faster time-to-market of the products.
3. Regulatory Success
Indeed, one of the most compelling benefits to embracing QbD principles is regulatory approval. The reason FDA and other regulatory agencies love a QbD-driven approach is that it aligns with their aim to ensure drug safety & efficacy. QbD processes that are well-documented are a good deal less likely to run into regulatory submission hiccups, which in turn provide a higher probability of approval and lower likelihood of post-approval issues.
4. Cost Savings
Although QbD can be phased, implementing it may initially require up-front time and resource investments, but the end result should yield cost savings. Pharmaceutical companies can realise substantial savings by avoiding defects, reducing rework and preventing further regulatory setbacks. In addition, the QbD emphasis on continual improvement means that cost-efficient options are identified across the life of the product.
5. Flexibility and Adaptability
Pharma is an industry niche that is very dynamic and always evolving with new technologies and scientific discoveries developing at all times. Design centric practice enables the companies to respond more efficiently and reduces there cost of change. With accurate data services, firms will be able to update these processes as new information is released or with changes in regulations so that quality will still be retained.
Implementation of QbD into Practice
Follow a Structured Approach Sequence of Application of QbD principles in Drug Development:
1. Quality Target Product Profile (QTPP)
What we should do is start from quality attributes for safety and efficacy of particular drug. For example, purity, potency, stability, etc.
2. Critical Quality Attributes (CQAs) Assessment
Understand which parameters give the most effect on product quality. It requires an in-depth knowledge of the product as well as how it is made.
3. Design Experiments
Apply Design of Experiments (DoE) to develop an understanding of the effects of input variables (e.g., raw materials and process parameters) on critical quality attributes, and as a basis to establish operating ranges for different equipment. This is a data-driven method based on making the manufacturing process better.
4. Establish Control Strategies
Formulate control strategies which will make sure whether the product maintains its quality levels that have already been pre-defined. This may include the use of process analysis technology combined with real-time monitoring.
5. Conduct Risk Assessments
Risk assessments can identify risks for each phase of development, as well as the risk alleviation strategies to be adopted. It means that instead of waiting for a problem to occur and then reacting, you can be preventive.
6. Continuous Improvement
Passion for Quality: QbD is a not a one time affair, it is constant dimension of quality. Keep using the data to monitor, analyse and make changes where necessary.
The Impact of QbD
In a typical drug development endeavor, a pharmaceutical organization will not have an idea of crucial quality properties. Consequently, the manufacturing process reveals unforeseen impurities that cause expensive delays and regulatory issues.
QbD Approach: On the contrary a QbD compliant company would carry out extensive studies on formation of drug and manufacturing process both. DoE helped them identify the critical variables and set up the controlled strategies. As a result, the yield is far more consistent and there are fewer adulterants in the final product.
In this case, the benefits of QbD are not only shorter development time and cost but also faster regulatory approval because of better data..
Conclusion
In an always-competitive life science industry, where innovation and quality shape the landscape, a design ethos for drug development is not only highly recommended,it’s mandatory. The principles of Quality by Design with their focus on knowledge, control through design and intervention at the system level are a comprehensive solution to many of the challenges being faced by organizations in pharma.
We at our quality and regulatory consulting company feel QbD has the potential to revolutionize new drug development.
These are principles that we think, if embraced by pharma companies, can lead to well-made products that are better and faster than their competitors, win regulatory approval and fulfil their mission of global health improvement.
Faced with an uncertain journey in the pursuit of continuous improvement mindset, Quality by Design provides pharmaceutical companies a direction to steer their ships towards more innovative and scientific approacheswhich are not only regulatory compliant yet most importantly improving human life through transformative medicines as well.
To learn more about how we can help your organisation get in touch with BioBoston Consulting today, or drop by our website
