Now that the biospecimen shipment has been received and is ready for the processing activities, we can start with managing the process order batch details. For that, we will use the Manage Process Order Batches application in the Manufacturing Management section.
Steps
Manage Process Order Batch Details
From this screen, we can navigate to the Manage Process Order Batches view of this particular order by clicking on the arrow pointing to the right.
In this view, we have the information on the processing slot (planned start and end date), the associated process order in the ERP, the batches (components and expected yield information), as well as documents and logs. On this screen, we change into the editing mode by clicking on the Edit button on the top right and enter the details page for each line item in the materials in the process order yield section.
In this view, we have to provide the information like Batch ID, Sub-Unit Type, Sub-Unit Qualifier, and Sub-Unit ID for all associated batches and sub-units of the planned processing activities. Save changes by clicking on the Apply button on the bottom right and repeat for all batches and sub-units. Once complete, click on the save button on the bottom right to save all changes and data. With the batch information prepared, the manufacturing organization now can start the processing activities.
Report Processing Start
For this, select the Report Processing Start application in the Manufacturing Management section of the SAP Cell and Gene Therapy Orchestration landing page. Select the correct processing activity using the Chain of Identity ID of the order and clicking on the arrow pointing to the right.
In the next view, we can now switch to the edit mode by clicking on the Edit button on the top right and enter the processing start date and the planned date of formulation in the appropriate fields. This will automatically calculate the expiration date based on your configuration. To save the changes, we click on the Save button on the bottom right. On this same page, scroll down to Process Order Components and click on Add to add the consumed material for this process order (the biospecimen samples that were received from the treatment center). This will open a new window where you can select the biospecimen material that was received.
In the selection window, choose the material that will be consumed by the processing activities (in this case, we will use both cryobags that were received from the treatment center). To save, click on Confirm to save the selection.
With the processing steps now underway, we can prepare the required labels for intermediate and final drug products.
Print Finished Product Labels
Using the Chain of Identity ID, we can navigate to the relevant order and then generate and print all labels that will be needed for the finished product and relevant secondary packaging for the produced sub-units.
Report Processing Completion
With the labels prepared, the next step will be the "Report Processing Completion and Yield" step which can be found in the Manufacturing Management section of the SAP Cell and Gene Therapy Orchestration landing page. We can use the Chain of Identity ID to navigate to the relevant view where we can report on the completion of the processing activities and provide information on the yield for the associated batches. For this, we switch to the edit mode and enter the relevant data for all subunits.
Here, we confirm that the batch sub-unit has been produced and report on the produced quantity using the appropriate fields and adding the unit of measure. Click on the button Apply on the bottom right to save changes and repeat for all sub-units.
Once the data has been provided for all sub-units, we also enter the actual processing end date and the date of formulation. Now we can save all changes by clicking on the Save button on the bottom right.
Manage Finished Product Disposition
Now that the processing steps have been completed and the finished product has been manufactured, we need to manage its disposition. For that, we navigate to the Manage Finished Product Disposition application in the Manufacturing Management section of the SAP Cell and Gene Therapy Orchestration landing page. Using the Chain of Identity ID we can navigate to the correct order.
In the next screen we switch to editing mode by clicking on the Edit button on the top right and then enter all individual batch items that have been produced.
Here, we can update the disposition status of all individual items of the produced batches. We can select the correct disposition status and apply changes by clicking on the Apply button on the bottom right. Once this information has been provided for all items, we can save all changes by clicking on the Save button on the bottom right. This step requires your e-signature. With this, we now have successfully accomplished all processing activities and dispositioned the finished product for being shipped and used at the treatment center.