ABSTRACT
INTRODUCTION Stress testing both on the drug substance and drug product complements the formal stability studies for registration and the knowledge gained from GMP maintenance studies (on-going stability studies). All data generated during development through to the marketing phase contribute to the database available for stability assessment. Although the ICH Stability Guideline Q1A does not require systematic stress tests on the drug product except photostability tests, some short-term tests on one batch are highly recommended ( 1 ) as part of development in order to understand the impact of high temperature on the product that could be encountered during shipment and storage. The result of these tests facilitates the evaluation of the temperature monitoring data and the decision as to whether a particular batch has to be withdrawn from the distribution chain.
