QUALITY BY DESIGN: PUTTING THEORY INTO PRACTICE

This book is written with all stakeholders in mind; the regulatory agencies and the healthcare industry, including their suppliers. As the process of adoption, implementation and interpretation of Quality by Design is currently the key driver to help industry bring products to market faster and at the same time provide maximum assurance of product quality. Though pharmaceutical companies need to abide the law and therefore comply with the applicable laws, rules and regulations, their goal must be to be profitable. A business case must therefore not only outline how compliance can be achieved, maintained and improved, but also how this will result in a positive financial impact. Global subject matter experts offer invaluable information that will guide companies who wish to: - Proactively address regulatory trends - Reduce or eliminate the number of reworked batches - Achieve better manufacturability and process robustness - Drastically reduce recalls - Achieve leadership in the industry Cutting the cost of drug development is an overarching goal for the entire pharmaceutical industry. Any program that promises to make a significant contribution to it will certainly be welcome. Drug regulatory authorities almost anywhere base their decisions on three criteria: quality, efficacy and safety. They take no account of the actual or potential cost of the product to the company. Consequently, in addition for a need to be compliant with regulatory requirements there is an equal imperative for industry to examine the value for money they get from process development and acquisition of knowledge.