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1
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Monitor fewer storage conditions, e.g. only at 30 °C/75%RH to support all filing zones and global labeling requirements
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Justification is included in the submission (see Colgan ST (2014); Freed AL. (2016)
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2
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Monitor reduced time points for DS or DP (immediate release, complex modified release) post-approval confirmation and/or annual commitment protocols
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3
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Employ bracketing or bracketing and matrixing when applicable
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4
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Monitor only attributes that are stability related quality attributes (SQRAs) or the single shelf life limiting attribute (SLLA)
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5
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Consider including planned/anticipated post-approval changes (PACs) in the initial Marketing Application (MA) (e.g. in the stability sections of the dossier itself (potential change) or as a post-approval change management protocol) as possible
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6
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Using ASAP, SRA, statistics, etc. to assess PACs, thereby reducing number of lots, time points, etc.
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7
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Exclusion of site specific stability information, even for those markets that require site specific stability
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