Shipping stability: This section should provide information on shipping stability studies for one lot to evaluate the tolerance of products to the anticipated shipping conditions. Shipping studies can be done under real and/ or simulated Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India. conditions and should include variable shipping conditions such as extreme heat or cold. Such information should describe: (a) the study report (including the protocol, acceptance criteria); (b) method used for simulated conditions; (c) conclusion and recommended shipping conditions.