ABSTRACT
The International Conference on Harmonization (ICH) stability guideline is divided into principal sections, one dealing with new drug substances and the with new drug products. The successful application of the ICH guideline depends upon an understanding of the guideline itself as well as the spirit in which it was written. The ICH stability guideline was written to standardize and improve quality, to reduce complexity and cost in the execution of stability studies and the subsequent preparation of stability documentation, and to accelerate the review and approval process. Differences in requirements based on varying local government regulations, nonharmonized national and regional pharmacopeia, and regulatory interpretation of customer and patient habits make the worldwide application of a single stability dossier for a new drug substance or new drug product a significant challenge. Testing methodology employed for drug product stability evaluations must be fully validated and demonstrated to monitor those product parameters that are susceptible to change during storage.
