How-to Apply Quality by Design (QbD) Principles to Process Validation

April 17, 2014 by

What does QbD mean for pharmaceutical companies?

Quality by Design (QbD) refers to a set of risk-based principles, applied to manufacturing practices in order to ensure that the development and processes yield a quality product based on solid scientific and engineering principles.

For pharmaceutical companies specifically QbD principles are based on regulations that have been around for several years (since 2006), such as ICH Q8 Pharmaceutical Development and ICH Q9 for Quality Risk Management and Q10 for Quality Systems. Thus, a majority of the QbD components for process validation are not unfamiliar.

When helping to incorporate the QbD principles into our clients’ process validation practices, we notice that a lot of the pieces are already in place. It’s usually more about organization of data consumption by all stakeholders. It then becomes a question of how to make the right data, available to the right people, for the right purpose, and how to automate these hand-offs so that the entire lifecycle becomes more systematic. ‘

Where is QbD Applicable?

QbD principles are applicable to the design stages of your product and manufacturing process, and where you perform verifications of the final design. These phases together are commonly referred to as “Design of Experiment” (DOE), or “Design Space.” According to the new guidelines for process validation, QbD has the greatest presence during the first phase of the product lifecycle, referred to as process design. Information gathered in this phase then serves as a basis for the activities conducted throughout the other process validation stages. To learn more about the phases of process validation read our recent blog post.

Implementing QbD practices can lead to a number of benefits, including:

1. A better understanding of the process and the product. With this you can make iterations with greater confidence, to land the most desirable outcome.

2. Innovation in your day to day practices. For example, you may want to investigate the possibility of introducing a Real Time Release Testing strategy, which will ensure your product has all of the desired quality attributes, and increase the time it takes to go-to-market.

3. Ability to offset initial development costs later on in the lifecycle due to increased process efficiencies. With QbD you can proactively address issues before they arise, and systematically overcome them when they do arise.

4. Getting ahead of the curve on regulatory compliance. While there is no definitive legal requirement to conduct QbD practices, the FDA and other agencies are currently trying to develop a way to make them an industry-wide set of regulations.

As part of our Validator software solution we offer a module specifically for Process Validation and Quality by DesignContact us to learn more.

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