Stability Testing in Pharmaceutical Industry: ICH Q1A(R2), Accelerated Studies, Shelf Life & FDA/Health Canada
Published by: Pharma Quality System Editorial Team • Editorial basis: 21 CFR 211.137 and 211.166, FDA ICH Q1A(R2)/Q1B/Q1E, 2025 ICH Q1 draft, Health Canada GUI-0001 and current ICH implementation STABILITY • ICH Q1A(R2) • ACCELERATED • SHELF LIFE • FDA • HEALTH CANADA Pharmaceutical stability testing demonstrates how the quality of a drug substance or drug product changes with time under defined environmental conditions. It supports shelf life, expiration dating, storage instructions, packaging decisions, stability-indicating analytical methods and ongoing assurance that marketed products remain within specification throughout their labeled life. Quick answer Stability testing in pharma places representative drug substance or drug product samples under defined storage conditions and tests them at planned intervals. Long-term studies establish real-time performance; accelerated and, where applicable, intermediate studies help evaluate sensitivity to environment...