What Are Change Controls And Why Are They Important In GMP?

Good Manufacturing Practices (GMP) are built on documentation. Change control systems provide a prescribed way to document alterations, adjustments, and modifications, no matter how big or small. Change control must be applied to every aspect of GMP to ensure that a facility and the products it produces are compliant with regulatory standards. In a GMP facility, change control is a key aspect of quality management systems and is overseen by the quality assurance team.

This blog reviews considerations for change controls and answers the following questions:
How can deviation trigger a change control?
How can an audit trigger a change control?
How are change controls implemented?