Abstract: Stability testing is the only way to demonstrate that the pharmaceutical product would meet the laid-down specifications within acceptance criteria throughout its lifetime. It is also required to gain the regulatory approval. The birth of International Conference on Harmonization (ICH) in 1991 and finalization of the guideline Q1A in 1993 led to harmonization of the stability test requirements for new drug applications, and was instrumental in development of a series of ICH and other National and regional stability guidelines, both for the new and existing drugs. There have been some recent developments, especially with respect to defining of storage condition for long-term stability testing. This note traces the new developments.
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