To comply with FDA regulations and GMP guidelines, pharmaceutical organizations must maintain tight control over data, particularly batch history. Life Sciences Supply Chain Management provides tools that ensure authorized users can efficiently and effectively manage batch history, including traceability.
Life Sciences Supply Chain Management allows for tracking the following information for batches directly in the Batches form (Inventory management > Inquiries and reports > Tracking dimensions > Batches):
Vendor account: When a batch is received via purchase order, it is automatically populated as the vendor specified in the order.
Manufacturer: When a batch is received via purchase order, it is automatically populated as the manufacturer specified in the order.
Customer batch number: Optional, it can be manually entered to track the reference to the batch number assigned by the customer to which the batch has been shipped.
Manufacturer batch number: Optional, it can be manually entered to track the reference to the batch number assigned by the manufacturer that originally produced the batch.
Sub batches: The total number of sub-batches received for the selected batch. It is automatically populated upon receipt and updated whenever sub-batches are created/deleted.
Destroy by date: Indicates the disposal date of the batch.
Packaging date: Indicates the date when the material packaging is completed (must be manually entered).
Bulk batch: used for finished product batches to identify the batch bulk. The field is filtered by the list of batches consumed to obtain the finished batch throughout the entire production process. It is not possible to choose as bulk a batch that was not involved in the production of the finished product.
Marketing authorization number: inherited by the item, can be modified for the batch.
Locked fields: If enabled, it prevents automatic updates from the parent item (for example, the recalculation of shelf-life dates upon update of the manufacturing date).
Database log: This parameter is automatically enabled if the sub-batch information has been modified and the modification is tracked in the database log.
Restrictions: This parameter is automatically enabled if one or more restrictions for the sub-batch are defined.
Cautionary statement: Indicates the investigational purpose of a new drug or states the intention of a shipment.
Use code: Indicates the approved uses for the batch.
Storage condition: Optional, it can be either automatically assigned upon registration if an active storage condition for the item has been defined or manually entered by selecting among the list of approved storage conditions for the item. The Description is automatically populated based on the selected value.
BOM or formula: BOM or formula number used to produce the batch. Together with the corresponding Name, it is automatically populated for items manufactured in a batch order/production order.
Note
Additional fields such as the maximum daily dose and Life Sciences Weighing and Dispensing information are part of the Life Sciences Weighing and Dispensing and Clinical Supplies Management modules, respectively.
In addition to the Customer batch number, Vendor batch number, and Manufacturer batch number, pharmaceutical companies may need to store information on additional alternate batch numbers for a selected batch for full traceability.
Life Sciences Supply Chain Management provides users with the ability to associate one or more alternate batch numbers to a batch by creating new records in the Alternate batch numbers form, in the View tab.
All the alternate batch numbers associated with batches are available in the Alternate batch numbers by batch inquiry (Inventory management > Inquiries and reports > Batches > Alternate batch numbers by batch). The information listed in this inquiry can be filtered to easily retrieve a specific batch regardless of the name used for the search.
Users can also easily view all sub-batches belonging to a specific batch by selecting the record in the Batches form and clicking Inquiries > Sub batches.
Life Sciences Supply Chain Management also allows to:
Define advanced rules for the calculation of the batch number.
Check, upon batch creation, if the generated batch number is unique in the current legal entity.
To have maximum control over sensitive information, Life Sciences Supply Chain Management provides users with the possibility to update/populate manufacturer batch details information with a dedicated button. From the Batches form, by clicking the Reset manufacturer batch details button, users are able to update/populate the Manufacturer field (inherited from the value applied during the purchase order registration) and the Manufacturerbatchnumber field.
Both fields can be secured with the electronic signature (Organization administration > Setup > Electronic signature > Electronic signature requirements, enable Reset manufacturer batch details) or change approval workflow.