Shelf Life Conditions

The different conditions that impact the quality of a drug substance or drug product over a period of time.

• Shelf life categories are defined in Data Administration.
• A category can be registered for an actual product shelf life that is registered with the registration authority, or labeled for a shelf life that is on the product package label. Examples that identify details: 4 Year(s) Registered, 2 Year(s) Labeled.
• Under each shelf life grouping node, for each category, only one shelf life detail can be approved.
• Under each shelf life grouping node, for each category, only one shelf life detail can be pending for one event.

Multiple shelf life details can be pending, but each must be for a different event.

• If a shelf life detail has a Pending Modify status, you cannot add a pending shelf detail with the same type and category for any event associated with the application. This prevents you from creating multiple approved shelf life details for the same PDS.
• Shelf life types can include After first opening, After transformation, In original pack, Unopened.
• You can edit shelf life type, shelf life, shelf life unit or shelf life category if shelf life/storage conditions detail attributes are in Pending Add status only.