Stability testing is fundamental to all drug development and manufacturing. All organizations need to have a clear vision
of phase appropriate stability study design, organized data collection, strong and appropriate data analysis, clear stability
reports with available analytical methods to achieve the product development goals of stable products going to the consumer
and the marketplace, and meet all of the regulatory requirements for submission. An integrated approach with clear organizational
ownership assures stability testing will add value to all development activities from early formulation, to setting appropriate
acceptance limits on lot release.
Thomas A. Little, PhD, is president of Thomas A. Little Consulting in Highland, UT, email@example.com
1. ICH, Q1A(R2) Stability Testing of New Drug Substances and Products, 2003.
2. ICH, Q9 Quality Risk Management, 2006.
3. ICH Q8(R2) Pharmaceutical Development, 2009
4. ICH, Q1E Evaluation of Stability Data, 2003.
5. ICH, Q1D Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products, 2002.
6. ICH, Q6B Specifications: Test Procedures and acceptance Criteria for Biotechnological/Biological Products, 1999.