Technical Guide: A Practical Guide to Change Control Systems Management

Change is accepted as part of everyday manufacturing operations by current good manufacturing practice (cGMPs) and FDA. Pharmaceutical manufacturers have developed excellent quality/compliance systems to minimize unplanned changes in the manufacturing/packaging operations.

However, planned changes also require a stringent set of controls to attain desired results. In recent years, FDA has cited a number of manufacturers for lack of comprehensive change control systems. The Agency expects industry to have quality/compliance systems in place, which should trigger a chain of events whenever there is change involving a drug product or medical device intended for consumer use.

The ultimate goal is to build quality into a drug product instead of testing a sample for conformance at the end, thereby rigidly controlling any changes and deviant behavior of the systems involved.

This paper will provide quality/validation professionals with basic concepts about change control systems, different types of changes that might be encountered in a pharmaceutical operation, and the means to control them.