The 7 C's Of A Compliant Manufacturing Change Control System

By Ave Anderegg

Manufacturers increasingly realize that effective change control in pharma, as well as medical device production, is integral to both continuous quality improvement and customer satisfaction. These two objectives motivate oversight from regulatory bodies as well as the manufacturers themselves.

Life sciences companies recognize that it's their primary responsibility – and in their best interest – to proactively determine if a proposed change might affect the safety or effectiveness of a product rather than relying on a U.S. Food and Drug Administration (FDA) inspector or International Organization for Standardization (ISO) auditor. At the operational level, the focus is shifting from error detection to prevention.

Learn about the manufacturing change control process, its requirements, and the characteristics a change control system should possess to be both compliant and effective.