The path to continuous improvement is well within research, and it starts with Quality by Design (QbD): a process that elevates product quality as a result of comprehensive risk management strategies.
This article will start by answering the key questions:
What is Quality by Design?
And, why is QbD important?
Then, we will dive into the key principles and guidelines behind it to provide you with a comprehensive overview of the applications needed to develop successful products in life sciences. Let's go!
What is Quality by Design?
So, what is quality by design? Quality by Design in the life sciences plays a key role in the design, development, and launch of new products.
The basic principle of QbD is that quality should not only be tested in products after delivery, but incorporated into products from the very start.
To this end, a key objective of QbD is to make sure all variability is identified, justified, and addressed well before the product goes to market. The goal here is for the end product to meet its predefined characteristics from the very beginning by eliminating errors and other discrepancies, thus creating a high-quality product that meets the customer’s needs while reducing risk for the manufacturer and reducing poor quality costs.
QbD can help to address cost and time problems, issues involving sales targets, dissatisfied customers, and even internal burnout on the manufacturing team. From pharmaceuticals to medical devices and even software solutions, experts leverage QbD across many different aspects of the life sciences industry.
In summary, the overarching goals of Quality by Design in life sciences are to:
- Achieve and maximize consistent quality
- Minimize manufacturer risk
- Improve patient safety and efficacy
- Meet customer needs
- Reduce variability and defects
- Facilitate continuous improvement
- Enhance regulatory flexibility through greater product and process understanding
- Streamline processes and increase efficiency.
Fix the disconnect before it costs you: integrate processes, people & information in your quality management system
Why is QbD important?
Now that we know , "what is Quality by Design?", let’s clarify the key question: why is QbD important?
Quality by Design benefits both the customer (who values safe and effective products) and the manufacturer (for whom quality and costs will be better understood and more predictable with a QbD approach).
The QbD process is important because life sciences organizations face a number of challenges in the early stages of developing a new product. These may include gaps between the:
- The manufacturer’s understanding of the customer’s needs and the customer’s own understanding
- The manufacturer’s understanding of the customer’s needs and the actual product design
- Product design and the final execution of the product
- Process development assumptions and real-world manufacturing variability
- Knowledge held within one team and how it’s communicated across R&D, manufacturing, quality, and regulatory groups
We’ve all been there. And while these challenges are perfectly natural, QbD can help mitigate them.
Quality by Design helps to close gaps such as cost and time overruns, failure to reach sales targets, unhappy customers, and even abandoned or delayed development timeframes. This is why QbD is important.
Recommended learning:
ICH Q8 R2: How to apply Quality by Design and win regulatory confidence
International QbD guidelines and strategies
Introduced in the pharmaceutical industry for the first time between 2009 and 2021, the international QBD guidelines and strategies define the model as:
“A systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management.”
QbD is often combined with Process Analytical Technology (PAT) strategies, which are designed to achieve product quality attributes to the highest standard. PAT is a system for designing, analyzing, and regulating manufacturing practices by measuring quality and performance.
.png?width=1560&height=2130&name=Overview-of-Process-Analytical-Technology-(PAT).png)
The U.S. Food & Drug Administration (FDA) and the International Conference on Harmonisation (ICH) focus extensively on building quality into pharmaceutical and other manufacturing processes, incorporating PAT throughout. When it comes to international QbD guidelines and strategies, ICH even goes so far as to outline the exact elements of QbD. These include:
Quality Target Product Profile (QTPP)
Defines how the product is intended to perform and helps identify the product’s Critical Quality Attributes (CQAs).
Product design and understanding
Focuses on identifying and evaluating Critical Material Attributes (CMAs) — the characteristics of raw materials that can influence product quality.
Quality Risk Management (QRM)
Provides the overarching framework that links all QbD elements: the QTPP, CQAs, CMAs, Critical Process Parameters (CPPs), control strategies, and lifecycle activities.
Process design and research
Determines the Critical Process Parameters (CPPs). This step links CMAs and CPPs back to the CQAs. Because the QTPP and CQAs define what “quality” must look like, manufacturers need to understand the root cause of any quality issue or KPI deviation before identifying which CPPs or CMAs might be responsible.
Control strategies
Detail how quality will be maintained throughout manufacturing. This includes product specifications, customer requirements, and defined controls for every step of the production process.
Product lifecycle management
Covers ongoing process capability assessments and continuous improvement throughout the product’s life.
Quality by Design principles: What does QbD entail?
Quality by Design generally consists of five major activities: Define, Discover, Design, Develop, and Deliver.
The process begins by defining the requirements of the final product based on the applicable customer needs, safety profiles, and product efficacy objectives.
While not defined in ICH guidelines, the following five-step framework summarizes how Quality by Design principles can be applied across the product development stages:
- Defining a product quality profile that represents how the product will perform. This should be a quantitative representation of the product’s clinical safety along with the KPIs for developers.
Summarizing what is known and identifying any knowledge gaps to reduce risk. - Designing the product while carefully defining quality characteristics that must be controlled to reflect the product quality profile.
- Creating a flexible, adaptable process for the product with the defined quality characteristics from the previous step.
- Establishing key specifications for the product and material characteristics that must be managed to achieve the desired outcomes.
- Developing a control strategy for all aspects of the manufacturing process, complete with a risk assessment composed of numerous steps.
- Consistent auditing of the manufacturing process and adaptation as needed to ensure high quality.
It’s important to note that QbD requires extensive multidisciplinary collaboration. Done correctly, Quality by Design allows life sciences organizations to thrive in their product development, from idea to final delivery. Subject matter experts from every discipline can gather to mitigate risk and ensure the highest possible quality of their product.
Now, let’s look at each step in more detail:
Define
Summarize the market and target customers
Here, life sciences teams must describe both the product quality attributes and the target demographic (or demographics, if there are multiple groups the product will serve).
A key principle of QbD is to not only include descriptions of the product and target customers, but also the product’s unique measured goals. These goals may refer to market share, lead times, launch date, performance, price point, or customer loyalty. Anything that provides clarity into the market can be of great use here.
Discover
Research the market and explore customer needs
Teams must not only research the customer’s exact needs—as well as the benefits of the intended product—but also connect those needs to the specific, measurable outcomes the product will help to achieve. While this research may in some cases be quite straightforward, in others it will include more advanced statistics.
The plans from this step associate the design, process, and control features and goals with the customer’s needs. This helps to ensure every feature is useful to the customer before the product goes to market.
Design
Create product features to meet those needs
Once you understand your customers’ needs, your team can begin designing the product so that it meets those needs, ideally more effectively than any of your competition. This is a creative process that encourages free thinking with a safety net in place. The goal is for teams to explore new ideas without creating undue risk.
In the design process, QbD incorporates principles such as benchmarking, multiple alternatives evaluation, and competitor research. Value analysis and frequent design reviews can help to maximize the product’s ROI here.
Develop
Build the processes needed to create those features
After designing the product, teams must develop the process for delivering the product. This is where process design comes in, and is a key step in making sure the manufacturer understands all the variables at play, the best ways to ensure quality, and the importance of measuring process capabilities on a frequent basis.
Writing a comprehensive control plan can be quite helpful at this stage. The plan will help to ensure all processes are free from defects or deviations.
Deliver
Identify and implement process controls as needed
QbD doesn’t end when the product is in production. Effective product delivery features continuous evaluation, improvement, and careful planning. This means that after developing the processes described above, teams should evaluate process controls too. Doing so will help them meet the goals outlined in the QTPP.
The intent of the above QbD principles is to infuse quality into the product from the very beginning in order to mitigate risk, appeal to customers, and achieve the highest possible quality. The result can be nothing short of transformative for life sciences manufacturers and their customers.
The best quality KPIs to track - the full guide for your quality team!
Applications of Quality by Design
And important aspect of what is Quality by Design, are the applications of Quality by Design. The applications that include or incorporate Quality by Design principles are far-reaching. QbD principles are increasingly reflected in regulatory submissions such as marketing authorization applications, post-approval changes, and scientific advice procedures.
Beyond regulatory submissions such as marketing authorizations or scientific advice requests, QbD principles are also applied in areas like investigational/clinical trial filings, post-approval change management, technology transfer, supplier qualification, and process validation strategies.
Organizations and other applicants in the sector can leverage QbD by learning more about the process—and by reading the ICH Q8, Q9, Q10, and Q11 guidelines listed here. These guidelines reveal how QbD should be presented. The European Medicines Agency (EMA)’s frequently-asked questions page on this topic offers valuable information as well.
How Scilife helps you achieve Quality by Design
Whether QbD is part of regulatory submissions, process validation, technology transfer, or change control, you need a structured system to manage it. That’s where a modern eQMS like Scilife comes in. Its solutions and tools are specially designed to help quality professionals centralize risk assessments, control strategies, design space documentation, and lifecycle change tracking, making every QbD decision traceable, reviewable, and inspection-ready.
QbD puts quality at the center from day zero, and that’s exactly where Scilife can make a difference.
Our eQMS supports your team from design to commercialization, ensuring every decision, document, and record is captured, connected, and instantly searchable. The result? Full traceability and a complete, step-by-step view of your lifecycle, at any moment, during any inspection.
Conclusion
With insight into what is Quality by Design, why is QbD important, and the principles and applications of Quality by Design, life sciences companies can succeed in developing products from idea to delivery. Together, teams from around the world are leveraging this framework to bring top-quality products to market, and you can do the same!
