Quality by design (QbD) means designing and developing pharmaceutical products and manufacturing processes to ensure predefined product quality objectives. Quality by Design (QbD) brings a systematic approach to drug development that aims to ensure quality by applying analytical and risk-management methodologies to design, development and manufacturing. The main concept of (QbD) is that all final product critical quality attributes (CQAs) are affected by raw materials and process parameters. Hence, if we identify the cause and effect relationship between the various inputs and responses, we can control the quality of the product by simply controlling the inputs such as raw material specifications or process parameters. As a result, the final product will always conform to the quality specifications.
A more systematic approach to development (QbD) can include, for example, incorporation of prior knowledge, results of studies using design of experiments, use of quality risk management (QRM), and use of knowledge management (ICH Q10) throughout the lifecycle of the product. Such a systematic approach can enhance achieving the desired quality of the product and help the regulators to better understand a company’s strategy.
Although pharmaceutical development has historically focused on a “quality by QC” approach, whereby emphasis is placed only on the final control and release of a product, the (QbD) approach builds quality into the product itself. This is done by performing development with a complete understanding of the product and its manufacturing processes.
(QbD) is based on the principle of continuous improvement and the growing need for manufacturing organizations to increase their understanding of products and benefit from the growing knowledge base that develops as a product moves through its lifecycle. The approach allows for organizations to continuously improve their development strategies and make on-going adaptations. This ensures that the root causes of any manufacturing problems are satisfactorily addressed and corrected as a project moves through scale-up from the lab, to the pilot plant and to commercial manufacturing.
In each development phase, the level of knowledge increases and the risk assessment can be refined and updated, giving the opportunity to correct any possible issues. Even when a product has been commercialized, the opportunity for continuous improvement does not cease, with new experience gained and data gathered that can still serve to fine tune the process and the product.
Improved capabilities to support change is where the (QbD) approach comes into its own. If quality is built inside a product development process, the updating of regulatory documentation following any manufacturing process adaptations may only require minor variations to be made. This is because a deep knowledge of the process and its parameters has already been established and data has been collected to support any updates. This differs from the old approach, where change was avoided due to the potential of product quality being negatively impacted. With a sound understanding of the product and its processes, it will be easier to determine which changes are acceptable and which ones should be avoided.
The (QbD) approach can provide manufacturing teams with a better understanding of the parameters of the development process. This means that the team may be able to fine tune certain aspects of the process if they were foreseen during the development and registered to the appropriate regulatory authority. Continuous fine tuning and redirection of the process can more consistently and accurately achieve results closer and closer to the target value.
Having a deep understanding of how the process parameters work and are interlinked may also make it less likely for batch failure to occur as a result of unexpected reasons, as all possible interactions have already been evaluated and are already known. This may have the added benefit of reducing overall costs.
Designing quality inside the process will ensure greater batch-to-batch consistency. This proven consistency will help better regulatory confidence in the robustness of both the process and product.
Possessing an extensive understanding of the processes provides a good indication of the quality of manufactured products prior to even testing them as the assurance of quality has already been built in. This reduces the need for controls over the intermediates and final products because real-time controls exist within the process itself. For both manufacturing organizations and their customers, this reduces time for manufacturing, testing and release, while also reducing costs.
(QbD) will become of greater importance as forward-thinking companies look to boost their production capabilities, reduce throughput times and adopt more continuous manufacturing processes. In this progressively non-stop manufacturing environment,(QbD) uses a data-driven approach to deliver better understanding of manufacturing processes, reduced likelihood of batch failures, more efficient and effective control of change, as well as greater return on investment, time and cost savings.
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