Pharmaceutical manufacturers of brand-name drugs must submit information to the Food and Drug Administration (FDA) about patents covering the drug and its approved uses. This information, published in the FDA’s Orange Book, includes a description of the scope of the patent, known as a “use code”. Information related to the approved uses for a product is critical as it may impact the timing required for the FDA approval of a generic drug.
Additionally, whenever a batch or sub-batch is involved in a specific transaction, the system should check their use code (for example, clinical use or laboratory use only) against the intended use of the transaction and return a warning/error message in case the selected combination is not appropriate.
Intended use code
Within Life Sciences Supply Chain Management, users can define the list of intended use codes in the Intended use codes form (Inventory management > Setup > Use codes > Intended use codes).
For each intended use code, it is possible to determine the level of restrictions that the system ensures during the manufacturing process to prevent users from performing actions that are not allowed by the GMP regulations.
The following options are available under the Restriction field:
None: no restriction. The user can add any ingredient to the batch order formula/picking list journal and any operation to the batch order route/route card journal.
Items: the user can add to the batch order formula/picking list journal only ingredients belonging to the formula assigned to the batch order. The user can set any operation to the batch order route/route card journal.
Operations: the user can only add to the batch order route/route card journal operations belonging to the route assigned to the batch order. The user can add any ingredient to the batch order formula/picking list journal.
Both: the user can add to the batch order formula/picking list journal only ingredients belonging to the formula assigned to the batch order and add to the batch order route/route card journal only operations belonging to the route assigned to the batch order.
The intended use code may be mandatory for some transactions while not relevant for others depending on the business process. For this reason, Life Sciences Supply Chain Management provides the capability to configure for each transaction whether the intended use code is mandatory, it should be assigned, or it is not required (Inventory management > Setup > Inventory and warehouse management parameters).
The following options are available:
No check, the Intended use code field can be left blank.
Warning only, if the Intended use code field is left blank, the system returns a warning message, but the user is allowed to continue.
Not allowed, if the Intended use code field is left blank, the system returns an error message, and the user is not allowed to continue.
The Intended use code can be assigned to the following transactions:
Batch orders
Production orders
Purchase orders (Header and lines)
Transfer order (Header and lines)
Sales order (Header and lines)
Planned production/batch/purchase/transfer/sales orders
In manufacturing, the Intended use code can be assigned to the formula/BOM header, and then inherited into the relevant batch order/production order and relevant planned batch order/planned production order.
The Intended use code field is available in the engineering change orders and can be modified in the formula/BOM header of engineering products. The Intended use code assigned to the planned order is inherited in the relevant actual order once firmed.
Note
The Intended use code can be set as mandatory in formula/BOM header (Inventory management > Setup > Inventory and warehouse management parameters)
Authorized users can reset the intended use code of the transaction to a different value via the Reset intended use code button, if needed. An electronic signature can be enabled for higher traceability and control.
The intended use code cannot be updated via the Reset intended use code button if a batch order formula line is already reserved, even if the batch order has not been released yet. The intended use code at the order line and the relevant header cannot be updated for purchase orders, transfer orders, and sales orders if the line is already reserved or received.
Use code
Users can define use codes in the Use codes form (Inventory management > Setup > Use codes > Use codes).
For each item, users can define a Default use code in the Item check groups form (Inventory management > Setup > Inventory > Item check groups).
The Default use code from the item check group is inherited by the Default use code field in the Manage Inventory tab of the Released product details form (Product information management > Products > Released products > Released product details), but the value for the selected item can be changed.
The use code selected at released product level is automatically assigned to newly created batches and sub-batches.
The Use code of a batch/sub-batch can be assigned and/or modified by clicking the Reset use code button in the Batches and Sub batches forms and selecting a use code among a list of values.
It is also possible to select one of more sub-batches in the Sub batches form and copy the ‘use code’ of the parent batch by using the Copy from batch > Copy use code functionality. This is useful if the properties of a batch are modified, and the same information must be quickly propagated to the relevant sub-batches to ensure consistency of the data.
By clicking Inquiries > Use code history in the Batches or Sub batches form, the History of use code inventory form will be opened and the log of all the use code changes for the selected batch or sub-batch will be displayed. The full history of use code changes for all batches and sub-batches will be available in the History of use code inventory form available in Inventory management > Inquiries > Batches > Use code history (for batches) and Inventory management > Inquiries > Sub batches > Use code history (for sub-batches).
Use code matrix
The use code of a specific batch/sub-batch can be validated against the intended use code assigned to a specific transaction (for example, transfer orders, batch orders, sales orders) to identify batches/sub-batches that are suitable for the selected transaction.
For the system to be able to evaluate whether a specific batch/sub-batch is appropriate for the intended use of a transaction, users must set up a use code matrix configuration (Inventory management > Setup > Use codes > Use code matrix configurations).
By clicking Setup, users can design the horizontal and vertical axes of the use code matrix by selecting the Question type (Horizontal or Vertical), the Question (Use code or Intended use code), and then adding the use codes/intended use codes from the Answer dropdown menu.
By clicking Outcomes, the system will open the Use code matrix configuration outcomes form, which displays a matrix where the number of lines corresponds to the number of answers for the Question type = Vertical, and the number of columns corresponds to the number of answers for the Question type = Horizontal. In this form, users can define whether a selected combination of use code and intended use code is suitable by ticking the checkbox corresponding to that specific combination.
A use code matrix configuration can also be created by copying from an existing one by clicking the Copy button. The new use code matrix configuration can then be updated as needed.
When a use code matrix configuration is created, it needs to be approved and activated by authorized users before it can be used. To complete this task, users can click the Approve and Activation buttons. Upon approval, the Approved parameter in the Use code matrix configurations form is automatically enabled and the Approved by field is populated with the user ID of the approver. Upon activation, the Active from field in the Use code matrix configurations form is automatically populated with a selected date of activation.
Users can specify if the ‘use code’ matrix configuration approval and activation should be secured via electronic signature by enabling the Signature required parameter for the Approve use code matrix configuration and Activate use code matrix configuration requirements in the Electronic signature requirements form (Organization administration > Setup > Electronic signature > Electronic signature requirements).
Approved use code check method
Users can configure the Approved use code check method in the Item check groups form (Inventory management > Setup > Inventory > Item check groups) and the value is applicable for all items using this item check group. The check method selected here is inherited to the Approved use code check method field in the Manage Inventory tab of the Released product details form (Product information management > Products > Released products > Released product details), but the value for the selected item can be changed. It is possible to select among the following options:
No check – During the inventory transaction the system will not check if the Use code of the selected batch/sub-batch is suitable for the Intended use code of the transaction based on the active use code matrix configuration.
Warning only – During the inventory transaction the system will check if the Use code of the selected batch/sub-batch is suitable for the Intended use code of the transaction based on the active use code matrix configuration. If the combination is not valid, the system will return a warning message, but the user will be able to complete the transaction.
Not allowed – During the inventory transaction the system will check if the Use code of the selected batch/sub-batch is suitable for the Intended use code of the transaction based on the active use code matrix configuration. If the combination is not valid, the system will return an error message and the transaction will be aborted.
The ‘use code’ validation is available in the following transactions:
Transfer orders: Reservation, picking, packing, and shipping
Batch orders/Production orders: Reservation, picking, batch order/production order start, and production-consumption
Sales orders: Reservation, picking, packing, and packing slip posting
Dispensing orders: Manual creation of dispensing orders and Life Sciences Weighing and Dispensing process.
Note
Dispensing orders are part of the Life Sciences Life Sciences Weighing and Dispensing. For additional information, please refer to the Implementation Guide for Life Sciences Weighing and Dispensing.