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

April 17, 2014 by
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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…


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The 3 Stages of Process Validation

April 9, 2014 by
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What is process validation? Process validation refers to the documented evidence that processes are operated within established parameters and that it can perform effectively to fulfill its intended purpose. With the FDA asking for more scientific arguments to support activities, the “life cycle” approach to process validation was born, as it provides opportunities for process validation across the entire product lifecycle. The lifecycle approach to process validation can be described in three stages: 1.    Process design and development The first step in the process requires four main activities be performed: Definition of Quality Target Product Profile or (QTPP), in other words, how you want your product to look like and behave. Definition of Critical Quality Attributes (CQAs), the features that are important to you in meeting the target profile. Definition of Critical Process Parameters (CPPs), which are the limitations or restrictions that may impact your product during manufacturing. When defining your CPPs you will also consider the features of machinery and equipment, such has operating ranges, speed, compression force etc. Finally, a risk assessment based on the anticipated interaction of your Raw Materials and Process Components and their impacts on CQAs. At the end of stage 1 you will have 5 major outputs: • The determination and verification of the critical process parameters • A high degree of understanding of…


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