Module 3 - Strategic case studies in practice

closure systems proposed in the application. The packaging system used in each stability study should be clearly identified.

The container closure system should be monitored for signs of instability. When appropriate, an evaluation of the packaging system should be included in the stability protocol. Even when a formal test for quality of the packaging system is not performed, the applicant should investigate any observed change in the packaging system used in the stability studies. The observations, results of the investigation, and corrective actions should be included in the stability report. If the corrective action requires a change in an approved container closure system, a supplemental application should be submitted. For general guidance on conducting stability studies, refer to the FDA Guideline for Submitting Documentation for the Stability of Human Drugs and Biologics (February 1987) . The stability guideline is undergoing revision and will be superseded by the FDA’s draft guidance for industry Stability Testing of Drug Substance and Drug Products (June 1998), once it is issued in final form.

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