The Stability Dossier: Common Deficiencies and Ways to Improve

Abstract

Stability testing on pharmaceutical products is carried out to demonstrate that product quality remains fit for purpose until the end of its shelf-life when stored as recommended, and during use by healthcare professionals or patients. International and regional guidelines on stability testing have been published for over 20 years, yet despite this, regulatory authorities still find a large number of deficiencies with stability dossiers. A survey of marketing authorization (MA) applications submitted in the UK between April 2012 and March 2013 found that 96% of dossiers had deficiency points with the stability dossier for the active substance and/or the finished product, representing an average of 3–4 deficiency points per application. The survey also revealed common deficiencies in both the active substance and finished product stability dossiers. A similar survey of MA applications carried out 10 years earlier found the same deficiencies with the stability dossiers, suggesting little improvement in their quality. The common deficiencies listed in this chapter represent an excellent starting point for discussion on improving the quality of the stability dossier. In addition, more in-depth practical guidance is provided herein on ways to improve the stability summary and conclusions, post-approval commitments, and presentation of the stability data, including consideration of the different approaches for marketing authorization variations and clinical trial applications.