Let’s face it – when you were growing up – perhaps mostly in your teen years – you never really listened to your parents. You might have pretended to, or developed that uncanny ability to not really listen – yet be able to recite the last sentence of whatever was said. A great skill indeed.
In recent news we have read that some of the major pharmaceutical companies are getting out of, or realigning their API manufacturing. This can mean that we are going to loose additional jobs. In the last few years about 150,000 jobs have been lost. Pharmaceutical companies have been increasingly acquiring their API needs from the developing countries.
The US Food and Drug Administration (FDA) introduced the idea of Quality by Design (QbD) in 2004 as part of the Process Analytical Technology Guidance. The purpose was to design quality into the product and process rather than try to test quality into the product at the end on the production line. It has been known for a long time that “quality by testing” is a low-yield and costly strategy.
QbD (Quality by Design a.k.a. having a robust and repeatable process which produces quality product without rework or re-testing) is financially important for the pharmaceutical industry and highly beneficial for the consumers; as it will ensure quality all the time, potentially alleviate shortages and lower costs.
To support a final quality assurance approach to manufacturing, it is the information and knowledge gained from pharmaceutical development studies and process characterization studies that lead to an effective quality control strategy, based on scientific understanding.
All of us talk about using common sense for everything we do. However, in certain instances we do things that are quite contrary because we are in our comfort zone. Many times the world tells us that we did not use our “common sense” or pay attention to the feedback or there is a time lapse.
The answer to the question of whether there could be a revolution to bring about Quality by Design (QbD) in pharmaceutical manufacturing, unequivocally, is yes. But we need some outsiders who can conspire with the insiders to be the flag bearers within pharma companies. Outsiders can be the counsels/co-conspirators to the insiders for the coup-d’état.
The title of the article in itself is provocative. Many have presented a “Quality by Design” (QbD) definition. Any process that is completely controlled (operating parameters and flow rates) and produces quality product without any intermediate product sampling and analysis in my definition would be considered a QbD process.
The U.S. Food and Drug Administration and the European Medicines Agency (EMA) have launched a new pilot program that will allow parallel evaluation of relevant development and manufacturing data components, known as Quality by Design (QbD), of new drug marketing applications that are...
It would be worth reviewing the future of pharma’s most discussed acronyms (PAT, QBA and QBD). The following are my interpretation of these acronyms. PAT (Process Analytical Technologies) means various analytical methods that can be used to convey the state of the sample as soon it is tested.
Much has been learned about the use of Quality by Design (QbD) since it was proposed by the FDA and ICH (2005) some five years ago. While the benefits of the approach are generally acknowledged, its implementation has been slower than expected.
The FT4 powder tester, backed by a unique process-focused approach to powder characterization, delivers the critical insight into powder behavior that companies need in order to understand their powders, achieve compatibility between powder and plant, and enable process optimization - supporting the aims of QbD.
Quality by Analysis (QBA) has been the MANTRA for manufacturing pharmaceuticals. This is due to the fact that, as we know, pharmaceuticals are manufactured using batch processes. Regulatory agencies would like the industry to move from QBA to QBD. QBD can result in a better batch process or a continuous process. Either of these process methodologies require a complete understanding of component chemistry and their mutual interaction.
In the four years since the ICH outlined the concept of design space in its Q8 guideline, pharmaceutical companies – despite depending on innovation for their livelihood – have been slow to adopt QbD. One year ago in this publication, two colleagues and I identified what we saw as the most common reasons that life sciences organizations resist QbD:
Tools modify the performance of cascade impactors currently specified in USP and Ph.Eur, allowing rapid identification of the fraction of a dose that will be inhaled. Cascade impactors are routinely used for the testing of all inhaled products.
Quality by Design (QBD) is an acronym we all believe in. It is an integral part of our daily life. We buy products using quality and price as the criterion. QBD is an essential part of business as it improves profitability. Almost every industry builds in quality as part of their product design and manufacturing practice.
n the United States, the FDA’s initiative on nudging the pharmaceutical industry to invent, develop and commercialize products using technologies that will result in product quality by design (QbD) is a challenging task. It is also a noble task that will have major business process implications and ultimately high financial impact on healthcare costs.