ABSTRACT
The following guideline sets out information on stability testing for a Registration Application within the areas of the EU, Japan, and the USA. The guideline provides a general indication of the information on product stability to be generated, but leaves sufficient flexibility to encompass the variety of different practical situations required for specific scientific situations and characteristics of the materials being evaluated. The guideline primarily addresses the generation of stability information for submission in Registration Applications for new molecular entities and associated drug products. Stability information from accelerated and long-term testing is to be provided on at least three batches. The length of the studies and the storage conditions should be sufficient to cover storage, shipment, and subsequent use. The long-term testing should cover a minimum of 12 months duration on at least three batches at the time of submission.
