Pharmaceutical companies must store material in containers intended to preserve products from contamination, hinder microbial growth, and ensure product safety during the container’s shelf life. When the container is opened to pick the required quantity of components, the content is directly exposed to the environment. For products that are sensitive to environmental contamination after container opening, the expiration date must be updated to an earlier date to ensure that the component’s quality, efficacy, and safeness are compliant with the standard for the whole shelf life.
Period after opening
Life Sciences Supply Chain Management allows users to define a Period after opening in days at the item level. This information can be defined in the Manage inventory FastTab of the Released products form (Product information management > Products > Released products). Since the expiration date must be updated to an earlier date for these particularly sensitive products, the system prevents users from setting a Period after opening in days longer than the Shelf life period in days.
If the Expiration date after opening parameter is enabled in the Production control parameters form (Production control > Setup > Production control parameters > Production consumption Tab), and the Disable automatic expiration date update parameter is disabled at the item level, the Expiration date is automatically recalculated and updated after sub-batches opening during production consumption as Consumption date + Period after opening in days.
The Container opening date field in the Sub batches form (Inventory management > Inquiries and reports > Tracking dimensions > Sub batches) is updated according to the consumption date, and the Opened field is automatically set to Yes.
When a sub-batch has the Opened field set to No, it is possible to manually update its expiration date based on the container opening date by clicking the Reset > Update expiration date button in the Sub batches form.
Print new expiry information on inventory labels
Life Sciences Supply Chain Management adds a new Expiry after opening field in the Released products form (Product information management > Products > Released product) that can be used to determine the expiry information that will be printed on the sub-batch label after the reopening.
Users can choose among the following options:
Not for reuse: a fixed, configurable text can be printed on the material label. The text is fixed for all the items with this configuration in the system, and can be defined in the Not for reuse after container opening field in the Warehouse management parameters form (Warehouse management > Setup > Warehouse management parameters> Print management).
Use expiration date: the Expiration date of the sub-batch is printed on the material label.
Use period after opening in days: the Period after opening in days of the item is printed on the material label.
Add the Expiry after opening field to the document routing layout to allow printing the expiry information above on identity labels.