Quality by Design and Process Analytical Technology: Important Tools for Buliding Quality in Pharmaceutical Products

Strategic framework for education and training in Quality by Design (QbD) and process analytical technology (PAT).

The regulatory and technical landscape of the pharmaceutical field is rapidly evolving from one focused predominantly on development of small molecules, using well established manufacturing technologies towards an environment in which biologicals and complex modalities are being developed using advanced science and technology coupled with the application of modern Quality by Design (QbD) princi...

Strategic funding priorities in the pharmaceutical sciences allied to Quality by Design (QbD) and Process Analytical Technology (PAT).

Substantial changes in Pharmaceutical R&D strategy are required to address existing issues of low productivity, imminent patent expirations and pressures on pricing. Moves towards personalized healthcare and increasing diversity in the nature of portfolios including the rise of biopharmaceuticals however have the potential to provide considerable challenges to the establishment of cost effectiv...

Pharmaceutical “quality by design” approach

10.4103/japtr.JAPTR_343_17 Dear Friends, Based on quality risk management, the pharmaceutical quality by design (QbD) has been emerged as a logical methodology for the development which commences with prior delineated goals and accentuates better understanding of product and process control. The basis of QbD strategy is International Conference on Harmonization guidelines. QbD approach is surfa...

Chapter 18 Process Analytical Technology ( PAT ) and Quality by Design ( QbD ) Multi - and Megavariate Data Analysis

Process Analytical Technology ( PAT ) : A Real Time Quality Assurance

Process Analytical Technology (PAT) promise to deliver a bigger, brighter future in terms of encouraging “the voluntary development and implementation of innovative pharmaceutical development, manufacturing and quality assurance” while ensuring patient safety and increasing profitability for the life sciences industry. No matter how you slice it, reducing raw material and batch losses, preventi...