Drug registration, stability studies support

Data from formal registration stability studies, and as appropriate, supporting data should be evaluated to determine CQAs that will likely influence the quality and performance of the drug product. The retest period or shelf life proposed should not exceed that predicted for any single CQA. 

Data on laboratory scale batches is not acceptable as primary stability information. Data on associated formulations or packaging may be submitted as supportive information. The first three production batches manufactured post approval, if not submitted in the original Registration Application, should be placed on accelerated and long term stability studies using the same stability protocols as in the approved drug application. 

Stability studies are used to provide data to support clinical trials, registration submission, or commercialization. There are different types of stability studies during the drug development process, which are diagrammed in Fig. 2.1. 

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