Reporting Stability Data

Information available—One batch with three months accelerated stability data reported in a supplement and one batch on long-term stability reported in the annual report. 

Significant Body of Data Not Available. Up to three batches with tliree months accelerated stability data reported in supplement up to three batches on long- term stability data reported in annual report. 

Stability First production batch on long-term stability data reported in annual report. 

I. Chemistry Documentation. Application/compendial product release requirements. Notification of change and submission of updated executed batch records. Significant body of information available One batch with three months accelerated stability data reported in changes being effected supplement and long-term stability data of first production batch reported in annual report. 

Stability testing—one batch, 3 mo. accelerated stability data in CBE and first production batch on long-term stability data reported in annual report... 

---