Bulk holding studies, drug

Bulk Holding Studies for Drug Product Intermediates... 

Studies must be conducted to provide data to support bulk holding times for in-process or intermediate materials. For a stable drug product, it is generally acceptable that no formal study is needed if in-process materials are held less than 30 days. For unstable products or materials that need to be held longer than 30 days, stability studies are necessary to verify the holding times do not affect the quality of the in-process materials. 

---