Chapter 2 - Global Regulatory Perspectives on Quality by Design in Pharma Manufacturing

Abstract

The legislations have almost frozen the processes used in pharmaceutical manufacturing overtime. Even after the receipt of drugs’ permits/certificates, even a small change in the method of manufacturing of medicines requires examination and approval of health authority, resulting in time and paperwork. The Food and Drug Administration (FDA) is at the forefront of work in the field of “Quality by Design (QbD),” which implements regulatory intelligence to modernize the understanding and control of pharma manufacturing processes. The applications performed within the QbD approach, based on scientific data and with previous knowledge and experiences, are now part of the process for change with the flexibility of real-time release. As a result of these changes, the process is proved to function and the confidence in the system is increased.