A Stability Program in pharmaceutical manufacturing is a systematic approach involving the testing and evaluation of pharmaceutical products under varied environmental conditions to ascertain their shelf-life, degradation characteristics, and optimal storage requirements over time. This program encompasses stability studies, testing, and monitoring conducted in accordance with predefined protocols, schedules, and acceptance criteria. The data garnered from these activities are crucial for supporting regulatory submissions, substantiating shelf-life claims, and ensuring the continued quality, safety, and efficacy of products throughout their intended storage and usage period.
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