What is a “Change Control” system, and why is it so important?

“Change control” is a formal, systematic process for managing any changes that could affect the quality, safety, efficacy or compliance of medicines. Such changes may include changes to manufacturing processes, replacement of raw material suppliers, updates to analytical methods, upgrades to critical equipment, revisions to Standard Operating Procedures (SOPs), and even alterations to factory facilities. The change control process requires every planned change to be reviewed and approved by a cross-functional assessment team (usually including representatives from production, quality and regulatory affairs) before implementation. The purpose of the assessment is to analyse comprehensively the potential impact and risks of the change and determine the measures required (such as revalidation or notification of the regulatory authority) to ensure that the system remains under control after the change. The application, assessment, approval and implementation of all changes must be fully documented.