Japanese–English glossary
Long-term stability testing
長期保存試験chōki hozon shiken
A stability study at the proposed storage condition, run over the whole proposed shelf life, that provides the primary data for setting it. Under ICH Q1A(R2), applied in Japan through a 2003 MHLW notice, the general long-term conditions are 25 °C/60% RH or 30 °C/65% RH, with at least 12 months of data at submission. Testing is usually every three months in the first year, every six months in the second and yearly after that. Biologics stored refrigerated or frozen are tested at their actual storage temperature, under ICH Q5C.