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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