ABSTRACT
ICH STABILITY GUIDELINES Stability testing was the first “Quality” topic on the ICH work program in 1990 as there were considerable differences between the EU, United States, and Japanese requirements at the time. Drug products are often marketed in several strengths and package types. The need for testing combinations of strength, packaging, batch, storage conditions, and test intervals leads to an expensive stability chamber investment and analytical program. When this was combined with the complications of different testing requirements for different countries, the amount of testing needed was enormous. Thus, as stability testing is one of the major costs in developing a new product, and, as many subsequent changes to a drug product also have to be supported with new stability data, it was important to minimize these costs and avoid delays by developing an internationally harmonized approach to stability testing.
