A question always comes up during holiday dinners – “What do you do again?”
I begin sweating. Hmm…I have to think for a minute before I respond.
Then it goes something like this:
Me: “Well, you know that drugs you take are manufactured in big facilities but are designed by scientists. To do this well, we need to experiment. Just like your turkey recipe, there are many variables that could affect the outcome…”
Cousin: “Good… so how are the kids doing?”
So much for my QbD elevator pitch. I need help.
I turn to our community for help on how to describe QbD in 1 sentence.
So far 33 folks submitted their 1-sentences and a few more emailed.
If you can’t find one you like, please submit yours.
I will test out a few sentence over this holiday dinner and let you know how it goes.
- Making better drugs by listening to patients and using best practices.
- Clearly defining what is the intended purpose of the product and then designing this product so it will fit its intended purpose reproducibly throughout its lifecycle…
- Get to know your product and process characteristics and behavior well enough, as to pre-empt letting it slip out of the pre-defined frames (ie Quality standards)! Somehow making your process and product mistake-proof from the early stages of development~ Pokayoke
- A systematic and scientific approach for developing a product.
- It is a systematic method of incorporating all the desired Quality parameters of the target product within the designed manufacturing process.
- A systematic approcah to establishing control strategy for the manufacturing process that gives freedom to operate at defined boundaries outside of the normal ranges with end result being regulatory relief.
- It is a systematic approach for better understanding of product and process.
- The effectiveness or efficacy of the drug product was achieved and reproducible consistently by controlling the quality of the process parameter and thus design by quality.Thanks
- ObD is the end of trial&error, it is based on a planned Design of Experiments (DoE), risk- and robustness evaluation, that gives freedom to operate inside of multivariable Design Space with the end result to obtain much more flexibility to change working conditions as in the past and at the same time reducing regulatory oversight to a minimum.
- Three words…Predefined goal sound science good risk assessment=QbD
- QbD can be defined as “To achieve the quality of product by working within predefined parameters (design space)”
- Systematic approach for development and manufacturing of products.
- “Establishing quality in the drug product with scientifically defined studies for formulation variables and process variables control”.
- For those ‘not in the industry’: you might explain that while raw materials fed into a drug/ dose manufacturing process will vary – sometimes widely – if the critical quality attributes of the raw materials and the critcal parameters of the process (manufacturing/ packaging, ,,,) are well understood, then it’s possible to write process directions that yield product having consistent quality.
- Quality by Design is a philosophy based on the concept “quality has to be built in not tested for”.
- Quality by Design: This is not a new word. It is there in other industries since I think 1900. Everybody who works always strives for Quality. During this process every body uses the technology, Engineering and Science. That is basics of Statistics, Design and mathematics. It all depends on available time to do experiment, cost of API and urgency to enter the market. How well you design still we will struggle for quality. Hence, Quality by design is a dynamic word which requires in every stage of product life cycle and challenging.
- Designing and developing formulations and manufacturing processes to ensure predefined product quality
- An approach which designs new inherently efficient systems which requires an integration of systems understanding, techniques, and domain knowledge.
- QbyD is to develop a product with all acceptable formulation and process parameters in order to ensure the quality without affecting the efficacy and safety of dosage form
- Designing new products, or manufacturing processes following a deliberate, science-based, and well-documented approach that seeks to gain a thorough understanding about the product and the manufacturing process, which, in turn, leads to high quality products that can be manufactured day-in, day-out.
- QbD is a concept of Quality= Safe, efficacious, stable product development by Design= Understanding and controlling product (Drug+excipient), Process (manufacturing process variable)
- The design that gives you flexibility to manage the process parameters changes without compromising the quality of the product.
- Designing and developing of formulation and manufacturing process to ensure consistently predefined quality by understanding how formulation and manufacturing process variables influences the quality of product.
- QbD means designing the parameter which affect during achievement of the predefined product characteristics by developing desired quality in the final product.
- QbD = Quality Input is proportional to the Quality Output
- Experiments to develop effective medicine
- QbD is an incremental build-up of process understanding throughout development assuring Critical Quality Attributes (CQAs) of the drug substance or drug product using a multivariate experimental approach.
- QbD is an EVOLUTION, not a REVOLUTION, in the approach that take to the development of an efficient manufacturing process.
- QbD is an approach to incorporate the quality attributes during product designing with a complete process and product understanding, rather than testing the product for quality after designing it.
- QbD is to ensure the quality of the products at various stages of the product manufacturing. To ensure the manufactured product meets to all quality parameters and safe for human being in all aspects.
- To me, QbD is a risk management tool, which allows you to better understand the products and its associated processes. Its a tool which allows ‘Quality’ control throughout the entire production process to minimise/eliminate batch rejections at the point of end-product testing for release, which then has direct impact on cost. At the end of day, businesses want to save on cost and QbD, if implemented correctly, can help achieve this.
- QbD begins with assessing the factors or experimental variables for each project milestone to develop a sound scientific strategy to evaluate the importance of the factors on product quality. Upon completion, you have a statistically significant set of data to perform a good risk assessment upon which to base the scientific strategy for the next project milestone. In this way, product variation and experimental factors are continually monitored and risk assessments updated to provide a comprehensive and unbiased informational package for your project as it currently stands.
- What’s your Elevator Pitch for QbD?