Sub Batch Numbers vs. Serial Numbers: Improving Traceability in Life Sciences

 If you are a life sciences organization in pharma, biotech, medical devices, or clinical trials/ supplies—you must identify and track each container of GMP-critical materials. While Microsoft Dynamics 365 Finance and Supply Chain Management does let you manage and track batch numbers and serial numbers, it does not map single product units like drums, bags, or bottles, within a batch.

STAEDEAN Life Sciences Solution's Sub-Batches Solve the Problem

To address this critical requirement for life sciences organizations, STAEDEAN adds a new 'sub-batch' tracking dimension that enables traceability at the container level. The solution also streamlines integration and data exchange with supply chain partners including 3PLs, CMOs, and serialization applications.

What are the advantages of sub-batch numbers vs. serial numbers?

Sub-batches help organizations overcome the limitations of serial numbers (e.g. non-parent-child relationship between batch and serial numbers) and offer enhanced features, including:

• Full traceability backward and forward
• Parent-child relationship between batch numbers and sub-batch numbers
• Complete lot/container genealogy
• Configurable sub-batch number format
• Data integrity enforcement: One sub-batch cannot be in multiple sites/warehouses/locations/license plates at the same time
• Extensive properties for sub-batch numbers: 

a. Shelf advice date, best before date, and destroy by date

b. Desiccant expiration date

c. Sub-batch type

d. Status (blocked/ unblocked)

e. Reason code

f. Storage conditions

g. Container configuration

h. Cautionary statement

i. Restrictions and Restriction type

j. Use code (the system checks the use code against the intended use of the transaction and returns a warning/ error message if the selected combination is not appropriate)

• Sub-batch properties are inherited from the parent batch number and can be modified by authorized users
• Sub-batch properties can be copied from the parent batch number for updates or locked to prevent updates
• Sampling and sample management depends on sub-batch numbers
• Label printing with sub-batch barcode and sub-batch properties
• Simplified scanning labels with handheld devices (single scan; no need to scan location, item number, batch number, etc.)
• Facilitate the integration with 3PLs, CMOs, and serialization applications

It is also important to note a critical distinction between serial numbers and sub-batch numbers: Serial numbers do not have to be unique so multiple items of different batches can have the same serial number, whereas sub-batch numbers must be unique.

When to Use Sub-Batch Numbers vs. Serial Numbers

STAEDEAN has executed multiple ERP implementations for Life Sciences organizations worldwide and recommends the use of sub-batch numbers to identify and track containers of GMP materials such as:

• Finished products
• Intermediate products
• Active ingredients
• Excipients
  
  

Why STAEDEAN Life Sciences solution?

Our solution partly extends the serial numbers features in Microsoft Dynamics 365 Finance and Supply Chain Management and adds the following functionality:

• Advanced serial numbering
• Expiration date
• Block status
• Serial registration in the procurement and manufacturing process
• Serial attributes
  
  

STAEDEAN Life Sciences leverages in-depth industry expertise to enhance traceability, helping you achieve compliance seamlessly.

To get your questions on sub-batch numbers answered