CMC基础(英文)教材课程.pptVIP

Basics of CMC – Drug Product Stability Drug Product Stability Protocol, Specifications, and Commitment Stability data: Accelerated – 1, 2, 3 months at 40°C, 75% RH Long-Term – 3, 6, 9, 12, 18, 24 months at 25°C, 60% RH Stress studies or stability indicating method. 24 Months expiration if no significant degradation under accelerated. Drug Product Stability (Cont.) Commitments: Place at least one batch annually on stability at shelf-life storage conditions (25oC/60% RH). Report data to FDA annually. May have to withdraw batc