Quality by Design: A scientific approach for production processes

Quality by Design is a systematic and scientific approach to the development and production of products, often used for the production of drugs. A few years ago it was...

Quality by Design is a systematic and scientific approach to the development and production of products, often used for the production of drugs. A few years ago it was introduced in the international guidelines for the pharmaceutical industry.

The Quality by Design approach is a basic model that is often used in the development of pharmaceutical products and processes as it implies the development of experimental procedures using statistical tools. The use of multivariate strategies allows you to design a quality system that ensures a quality end product.

The PAT guidelines (Process Analytical Technology) that the FDA released in fact recommend the use of multivariate strategies as useful tools for the understanding of the processes, continuous improvement and development of strategies that minimize the risks.

Quality by Design is a systematic approach to the development of systems that begins with predefined objectives and emphasizes the understanding of products and processes through the development of mathematical models and risk management. Quality by Design is therefore a fundamental approach for the pharmaceutical industry and requires a change in their way of working, planning and designing the quality of the drug from the earliest stages of development. The core concept of the approach is that quality cannot be tested into products, but should instead be built in during the design phase!

While some pharmaceutical companies have internal experts that use the approach to improve processes, many companies outsource the task to specialized business consultancy firms. The Italy-based team at PTM Consulting for example, applies internationally recognized scientific methods in order to rationalize the production processes of companies in the Life Science and Food industry. The Quality by Design approach has many advantages: reduced time to market, risk and operating costs, optimization of Change Management and Life Cycle Management and propensity for innovation.

If you would like to find out more, visit their website for further information: www.ptm-consulting.it

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Project Management
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