Stability storage and testing of ophthalmic products for global registration.

Regulatory stability testing requirements for various types of ophthalmic products, including eyedrops, eye ointments, ophthalmic inserts, injections, irrigating solutions, lens washes, and lenses, are not always straightforward. The International Conference on Harmonization (I CH) guidelines do not completely address all of the stability conditions required for these types of pharmaceutical products and medical devices; regulatory agencies around the world still differ on the exact data requirements, storage conditions (especially temperature and humidity conditions), and certain testing methods. These uncertainties make the development of a global ophthalmic product very difficult. This article reviews many of the appropariate internationally recognized, regulatory guidelines and many of the important points to consider in stability studies for new ophthalmic products. Discussions of regulatory experiences and Expert Reports provide insight to common questions frequently asked by regulatory agencies on these types of products.