Science and Risked-Based Stability Testing Strategies-a Test Case on the Global Implementation and Regulatory Reception.

ABSTRACT

The global regulatory implementation and acceptance of a science and risk-based stability (SRB) strategies for a stable drug product is reviewed. This stability strategy may also be referred to as "lean stability" since it includes a stability protocol reduction in the number of tests and time points than might normally be applied. A product line extension (new solid dosage form) for a well-understood product was used as a test case for this stability strategy. The drug product line extension was filed globally with a proposed reduction to analytical stability tests and frequency. This stability protocol is aligned with the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Q1A (R2) stability guidelines (ICH Guideline Q1A(R2), 2003), the World Health Organization (WHO) (WHO INT. [Online], 2020), and most country regulatory guidelines. Although this strategy was not accepted universally, the strategy enabled opportunities to engage in productive dialogs with regulatory authorities in several countries on how the case leveraged product understanding and development knowledge to develop a fit for purpose stability protocol. A persistent and consistent effort from industry to move toward product-specific protocols based on product knowledge and stability risk assessments should lead to further acceptance of science and risk-based stability strategies in all regions.