Harmonising Change Control Standards in Global Multi Site Organisations Understanding Change Control in the Regulatory Landscape Change control is a vital component in the pharmaceutical and biotechnology industries. It acts as a systematic approach to managing changes in regulatory submissions, ensuring compliance with the US Food and Drug Administration (FDA) regulations and other global standards. Effective change control mechanisms allow organizations to adapt to new data, processes, or technologies while maintaining the integrity of their quality systems. This section provides an overview of change control, its importance, and core regulations governing these practices. In the United States, change control is…