Quality by Design—is a powerful instrument to make pharmaceutical production safe, robust and more efficient. But ten years after starting we are still at the beginning of the QbD era. What has to be done to make the concept a breakthrough?
Quality by Design (QbD) has been a buzz word in pharma for a decade now. But unfortunately many still consider it mainly a buzz word although it has become daily practices in many pharmaceutical companies and in several regulations. For some companies QbD has proven clear business benefits such as more robust processes or faster approvals. Although we are starting to see the impact on pharmaceutical products and manufacturing technology, it is still not as recognized across the pharmaceutical industry as many of us had thought when the concept was introduced.
Some of the most experienced pharmaceutical companies were early adopters of the QbD methods and technology and today some of them have demonstrated in public how they are harvesting the benefits of a science and risk based approach. But ten years after we are still only at the beginning of the QbD era.
How Process Analytical technology Works for Big Pharma
In fact, there are now many practical examples of application of Process Analytical Technology in pharmaceutical applications, but many of these are “islands of PAT information” rather than part of an integrated quality management philosophy based on the QbD principles.
In short, the principles of Quality by Design of pharmaceuticals may be summarized as a systematic approach for development and manufacturing of pharmaceutical products that starts during development and continues during the manufacturing until the end of the life cycle of the pharmaceutical product. It begins with considering the patient needs, establishing a targeted product profile and considers what is necessary to enable a product to be designed and manufactured to the expected target throughout its life time.
A Systematic Approach for Quality by Design
In popular terms the systematic approach includes to identify the way the product should work in the patient, its critical quality attributes in order to work as intended with safety, efficacy and quality in mind. The material attributes as well as process parameters must be controlled during manufacturing to ensure this. The method by which the product shall be manufactured including the procedures, the in-process controls and other quality measures can all be summarized in a control strategy for the manufacturing of the product.
For a product developed by QbD principles the control strategy may be so well defined that also a wide set of tolerances, acceptable ranges and correlations between parameters have been investigated and defined, leading to a so-called “design space” of the manufacturing process for the product. This brief introduction will not be enough to understand QbD in depth, but the key is that it is a systematic approach based on scientific understanding of the product, process parameters and material attributes combined with a systematic risk management approach to design a robust and predictable manufacturing process.
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