The formula for the compounding process of pharmaceutical products can include active ingredients. The active ingredient is characterized by a batch-specific potency evaluated during quality controls, determining the ingredient’s efficacy. The compensating ingredient is used to balance the quantity of the active ingredient based on the defined compensating factor. The filler ingredient is a neutral ingredient that is used to reach the desired output quantity of the manufactured product. The required filler quantity is calculated based on variations in the active ingredient and the compensating ingredient quantities compared to the standard quantity.
The relation between active and compensating ingredients is set up in the Compensation principle form, which can be opened from the formula lines by clicking Ingredients > Compensation principle. The Factor field specifies the efficacy of the compensating ingredient as a compensator. Multiple formula lines for the same active ingredients can be part of the same formula. Life Sciences Supply Chain Management™ displays the Record-ID of the active ingredient formula line in the Compensation principle dialog to allow users to distinguish between different formula lines for the same active ingredient.
The potency of some active ingredients is not stable during the product’s shelf life. Therefore, it must be retested right before the manufacturing process to ensure that the right amount of active ingredients is used. Additional quantities may also be required to produce finished products with suitable specifications.
Life Sciences Supply Chain Management extends D365 standard functionality to allow users to have a visual clue to check if the batch balancing has been executed for a specific batch order by looking at the Batch balancing parameter in the All production orders form or in the Update FastTab of the batch order details.
The Batch balancing parameter is disabled by default and is automatically enabled after the batch balancing has been successfully executed for the specific batch order. If the batch order Status is reset to a status different than Released, the Batch balancing parameter is disabled.
Once the Batch balancing parameter is enabled, users can release the batch order to the warehouse again, even if the batch balancing process has already been executed.
Life Sciences Supply Chain Management extends D365 standard functionality to allow users to add a new line of the active ingredient in the batch order formula line by enabling the Add active ingredient formula line parameter in the Production control parameters form (Production control > Setup > Production control parameters) when the batch order Status is set to Estimated, Scheduled, Released, or Started. Additionally, enabling the Add active ingredient formula line parameter enables batch balancing when a picking list journal is already available for the batch order.
Note
A warning message to prompt users to execute the batch balancing process again is displayed when the reservation for a batch order formula line for an active ingredient is manually updated.
By enabling the Automatic batch balancing configuration key, Life Sciences Supply Chain Management allows users to skip the batch balancing process by enabling the Skip batch balancing parameter in the Production control parameters form (Production control > Setup > Production control parameters).
When the Skip batch balancing parameter is enabled:
Users cannot execute the batch balancing process for a batch order (that is, the Batch balancing button is disabled for batch orders), and the required quantity of the active ingredients needs to be reserved:
Manually, via the Reservation form in the batch order formula lines.
Automatically, via the Reserve lot button in the Reservation
Automatically, based on the reservation principle upon batch order status update.
The quantity to be reserved is the estimated quantity calculated based on the batch order quantity, and it does not consider the potency attribute value of the reserved batch(es).
Users can define if the active ingredient should be automatically reserved based on the reservation principle (for example, FEFO) via the Reservation field in the batch order formula lines (Production control > Production orders > All production orders > Production order Tab > Formula button). The Reservation field is automatically inherited from the item’s item model group, and it is editable.
Users can release the batch order to the warehouse via the Release to warehouse button (Production control > Production orders > All production orders > Warehouse Tab) without executing the batch balancing process.
When the Skip batch balancing parameter is disabled, the execution of batch balancing is mandatory to release the batch order to the warehouse.
By enabling the Automatic batch balancing configuration key, Life Sciences Supply Chain Management enforces users to dispense batches of active material following a determined sequence. Users can view and modify the order in which reserved batches for a specific Lot ID must be weighed in the Active batches form (Production control > Production orders > All production orders > Production order Tab > Formula button > Ingredients > Active batches).
Note
The Active batches button is enabled only for lines with Ingredient type Active.
The batches of active ingredients are added to the Active batches form:
When the Marked checkbox is selected for a specific batch during the batch balancing process, if the Skip batch balancing parameter is disabled.
When the Reservation field is manually or automatically populated for a specific batch, independently from the Skip batch balancing parameter .
The batches added to the Active batches form are automatically assigned to a sequence number based on the sequence in which they have been added to the Active batches form.
Users can manually change the sequence of batches using the Move up and Move down buttons in the Active batches form. The sequence of batches can be modified only if the dispensing order line generated from the batch order containing the selected active ingredient has not been created or it is in Status different than Created.