The QbD approach: Key advantages in clinical and commercial phases

Quality by Design (QbD) allows for a systematic approach to drug development that is intended to improve quality by using analytical and risk-management methodologies for the design, development and manufacturing of new medications. The approach primarily aims to design quality into workflows from the outset. The objectives and attributes of a product will be determined in the initial stages of a programme, whereby a risk and data analysis are subsequently used to fully comprehend how processes may impact the characteristics and profile of a product. The robust framework provided by QbD therefore enables consistency in quality and attains pre-defined standards.

By outlining key objectives prior to development and examining the drug substance or drug product’s properties, drug developers can make sure that the drug is safe for patient possession and that it effectively delivers its intended therapeutic benefits. 

So, what other advantages does a QbD approach offer the pharmaceutical industry and how can it be properly utilised? 

Continuous improvement

The QbD approach is based on the principle of continuous improvement. By building a bank of knowledge as the drug substance or drug product progresses through its lifecycle, it is possible to adapt techniques to ensure that any potential disruptions or manufacturing problems are avoided. 

As the project moves from the lab right through to commercial manufacture, the risk assessment information can be continually updated, allowing drug developers to identify and correct the root causes of potential problems. Even when a product is launched to market, the process of continuous improvement endures so that both the process and product can continue to be fine-tuned. 

For final processes to offer a robust performance, Design of Experiments (DOE) are often employed in the development phase in order to identify the impact of interactions. By identifying critical factors ahead of time, risk mitigation actions can be carried out more easily and efficiently, which helps to reduce the number of rejected batches and find a robust process. This positively impacts both the environment and the production economy.  

Variations and deviations

A key attribute of the QbD assessment is the efficiency it offers pharmaceutical companies. By building quality into the development process, it often means that any changes made to regulatory documentation are relatively straightforward. Understanding the process and its parameters helps to ensure that the data collected supports these updates to the manufacturing processes. As described in The International Conference on Harmonization of Technical Requirements of Pharmaceuticals for Human Use (ICH) Pharmaceutical Development Q8 (R2) document, establishing a design space enables a domain within which robust processes are always obtained. If performing any minor variations or deviations in relation to the target manufacturing process, because of technical reasons, the process will still operate robustly, and a quality final drug product can be ensured.  

Understanding process parameters

One of the main benefits of using the QbD approach is that it gives the manufacturing team a clear understanding of the process parameters and how they work together. By doing so, it reduces the likelihood of unexpected reasons causing batch failure. This is because all potential interactions have been identified and evaluated; they are not unknown. 

In addition, manufacturing processes are multivariate in nature. This allows manufacturers to determine whether the batch is operating as it should, or if there is an early drift in performance. It is important that deviations can be detected as early as possible in order to act accordingly so that the process can return to its usual operating conditions before there is a substantial impact on performance. Without early detection, normal operation conditions cannot always be restored. 

Greater drug consistency

By designing quality into the process, greater consistency from batch-to-batch can be ensured. When product consistency is proven, it builds trust and confidence from regulators that both the process and product are robust. This may subsequently minimise the intensity of regulatory oversight during registration.

From a customer perspective, the QbD approach helps to develop loyalty and trust as the assessment provides greater drug consistency and reduces the likelihood of recalls. This results in customer confidence and maintains the credibility of the company. 

‘Right first time

A primary aim of a QbD approach is to make sure that ‘right first time’ is possible during product registration. Deficiency letters from regulatory authorities add time and money to drug development programmes. When a project is successful in its first instance, the shorter and leaner process of registration means that time to market is ultimately reduced. 

Reduced controls

The QbD approach can also give drug developers an indication of the quality of the manufactured products before they have been tested. In turn, reduced controls over the intermediates and final products can be achieved due to the inclusion of in-line and real-time controls within the actual process. To this end, drug developers can realise time savings during manufacturing, testing and release.


As forward-thinking companies look to improve their production capabilities, reduce timelines and introduce more continuous manufacturing processes, the QbD approach will see an increase in popularity. The data-driven approach used by QbD helps to serve the progressive manufacturing environment, as it gives drug developers a better understanding of manufacturing processes, decreases the amount of batch failures, gives more effective control of change and also, provide a higher return on investment. With regulatory authorities insisting that manufacturers design quality into products at each stage of development and manufacture, QbD will become increasingly crucial.  Read the full article here: 

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