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Table 3 Examples of Lean Stability Strategies in the Initial and Post-Approval Registration Dossiers

From: AAPS Workshop: accelerating pharmaceutical development through predictive stability approaches, April 4–5, 2016

No. Strategya Comments
1 Monitor fewer storage conditions, e.g. only at 30 °C/75%RH to support all filing zones and global labeling requirements Justification is included in the submission (see Colgan ST (2014); Freed AL. (2016)
2 Monitor reduced time points for DS or DP (immediate release, complex modified release) post-approval confirmation and/or annual commitment protocols
3 Employ bracketing or bracketing and matrixing when applicable
4 Monitor only attributes that are stability related quality attributes (SQRAs) or the single shelf life limiting attribute (SLLA)
5 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
6 Using ASAP, SRA, statistics, etc. to assess PACs, thereby reducing number of lots, time points, etc.
7 Exclusion of site specific stability information, even for those markets that require site specific stability
  1. aThe combination of strategies, e.g. No. 1 and 2 together, should be considered