Pressure to cut development costs and lower regulatory barriers while assuring product quality has stimulated the pharmaceutical industry to apply Quality by Design (QbD) to manage risk and gain process and product understanding. As a result, QbD is being widely promoted by regulatory authorities such as the Food and Drug Administration, and the International Conference on Harmonization.
When it comes to continuous quality improvement and removing defects from a process, Six Sigma continues to be the gold standard in manufacturing and process management. This structured, data-driven methodology for discovering problems relies on rigorous analysis of production and process data. For many companies, engaging in a Six Sigma process can be time consuming or even a bit daunting.
You may have heard the term Six Sigma used in conjunction with lean manufacturing, a Kaizen approach or continuous quality improvement. Perhaps you thought Six Sigma only applied to large-scale business operations, or that newer philosophies had overtaken Six Sigma as the most updated approach to quality management? But if you're looking for a way to improve your production processes or solve a problem you’re having with quality, Six Sigma might be the answer. Are you and your team familiar with these concepts? Here's an overview.
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Whether you work in engineering, R&D, or a science lab, understanding the basics of experimental design can help you achieve more statistically optimal results from your experiments or improve your output quality.
At the heart of any process used to manufacture biological products is a bioreactor setup that supports a stable and reproducible biologically active environment. The bioreactor provides a controlled environment to achieve optimal growth for the particular cell cultures being used.
Biopharmaceutical companies today are challenged to develop high producing cell lines as quickly as possible. Commercially available media may fall short of performance expectations required to meet targets. The alternative —fully customized media and feed development — requires significant funding, time and in-house expertise in media development.
In life science, biopharma and other areas of research, development and production, design of experiments (DOE) provides a systematic method to determine cause and effect relationships between factors and responses affecting a process, product or analytical system. But the key to understanding your results is effective analysis of your experimental data.
Worldwide demand for energy escalates every year, and the consumption of fossil fuels continues to increase despite the growing supply of alternative energy options. Globally, about 81 percent of energy comes from a finite supply of fossil fuels like oil, coal and natural gas. Fossil fuels are used to heat homes, run vehicles, power industry and manufacturing, and provide electricity.
Using a Quality by Design (QbD) approach for DOE supports ICH Q8 compliance
In pharmaceutical development, manufacturers must be able to demonstrate product robustness and deliver the intended quality of the product within allowable ranges for the claimed shelf-life period. Both international and country specific regulatory agencies, such as the FDA, pay close attention to these claims.