Stability testing

Studies that show how the quality of a drug substance or product changes over time under the influence of temperature, humidity and light, used to set the shelf life or retest period and the storage conditions. Japan applies ICH Q1A(R2) through an MHLW notice of June 3, 2003, and ICH Q5C for biotechnological products. A program combines long-term, accelerated and stress testing. Separately, Article 11-2 of the GMP Ministerial Ordinance requires ongoing stability monitoring of marketed products, and PMDA's ORANGE Letters have described sites that left unfavorable stability trends without action.