FDA Finalizes Stability Testing Protocol Guidance

Manufacturers of sterile products that test for container and closure system integrity in stability protocols, rather than for sterility, need not validate the tests for individual products that share the same type of container if they follow the FDA’s new guidance.

“If you manufacture a number of products that use the same type of container and closure system, you may validate your integrity test method using a bracketing matrix,” a final FDA guidance says. “It is not necessary to perform validation studies on each product.”

The guidance, “Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products,” was published in the Federal Register last month.

Besides the agency’s advice on validating integrity tests, the final guidance is largely unchanged from its draft form, which was released for comment in 1998.

Comments on the guidance can be submitted at any time. It is available at www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2008-D-0060-GDL.pdf.