GMP regulations define the minimum set of requirements the material needs to comply with to be consumed in the manufacturing process. For instance, the consumption of expired batches or sub-batches is not allowed.
By default, Life Sciences Supply Chain Management prevents manufacturing operators from consuming expired batches and sub-batches, however, introduces the possibility to override such controls since manufacturing processes intended for R&D or internal Quality research may not be fully subject to the same restrictions.
Therefore, it is possible to allow consuming expired batches and sub-batches as part of production picking list journals by enabling the Allow expired batch and Allow expired sub batch parameters in the Production control parameters form (Production control > Setup> Production control parameters).
Note
The parameters are disabled by default according to the GMP regulations, and access to the Production control parameters form is restricted via security.
Additionally, the system performs the following controls on the best before date, shelf advice date, and batch disposition status during picking list journal validation and posting:
Validates the best before date for batches and sub-batches, based on the item’s Best before date check method:
If the item’s Best before date check method is set to No check and the scanned batch or sub-batch has crossed the Best before date, no error/warning message is displayed.
If the item’s Best before date check method is set to Warning only and the scanned batch or sub-batch has crossed the Best before date, a warning message is displayed.
If the item’s Best before date check method is set to Not allowed and the scanned batch or sub-batch has crossed the Best before date, an error message is displayed.
Validates the shelf advice date for batches and sub-batches, based on the item’s Shelf advice date check method:
If the item’s Shelf advice date check method is set to No check and the scanned batch or sub-batch has crossed the Shelf advice date, no error/warning message is displayed.
If the item’s Shelf advice date check method is set to Warning only and the scanned batch or sub-batch has crossed the Shelf advice date, a warning message is displayed.
If the item’s Shelf advice date check method is set to Not allowed and the scanned batch or sub-batch has crossed the Shelf advice date, an error message is displayed.
Validates the batch disposition status of the material, based on the item’s Batch disposition status check method:
If the item’s Batch disposition status check method is set to No check and the scanned batch (or the parent batch of the scanned sub-batch) has the Batch disposition status set to Unavailable, no error/warning message is displayed.
If the item’s Batch disposition status check method is set to Warning only and the scanned batch (or the parent batch of the scanned sub-batch) has the Batch disposition status set to Unavailable, a warning message is displayed.
If the item’s Batch disposition status check method is set to Not allowed and the scanned batch (or the parent batch of the scanned sub-batch) has the Batch disposition status set to Unavailable, an error message is displayed.