Label Groups
Introduction
Label groups define sets of regions that correspond to the countries and/or languages specified on labeled kits. The use of label groups in a specification ensures that this information is considered when forecasting production quantities and timing.
A Label Group Code and a Region Code are always mandatory.
If any one Region appears in more than one label group, Start Date and End Date values are required to ensure they are correctly activated and assigned. A label group will be considered inactive outside of the start and end date assigned.
If there is an overlap in Start and End Dates between any two label groups, Rank values are required to specify the order in which label groups should be used in the Production Plan.
When label groups are not used in a specification the production plan will still show a label group filter. In this case, all productions will be grouped into a single ‘default’ label group. This label group will also appear in the interpretation logs.
How are label groups used to meet demand?
At sites, demand will be satisfied for the highest-rank, active label group first; then for the lower-ranked, active label groups defined in that region in order of rank.
When the highest-rank, active label group runs out at a site, the system will use supply from lots (including planned and actual lots) for other lower-rank, active label groups defined in that region.
The system will also request re-supplies of these label groups to depots, if the supplying depot doesn’t have enough of the current label group to satisfy the demand.
When current label group becomes inactive (i.e., the end date is reached, or is superseded) the available supplies can still be used and will be included as countable inventory at sites.
Within a label group, lots will be selected by the earliest expiry first. This is not applied across different label groups, based on the assumption that the higher-ranking label group will have lots expiring first (this should always be verified by the user).
Depots will behave similarly to sites. Supplying depots ‘see’ demand for lower-ranked label groups as real demand and consider it when forecasting the production plan. However, depot buffers are only created for the highest-rank, active label group for a given region and dispensing unit.
Label groups in other specification tables
A Label Group column may be added to a Planned Lots specification table to correlate planned productions to label groups.
A Label Group column may be added to a Planned Depot Shipments specification table to specify which label group should be included in a planned shipment.
Example
Label Groups table
Label Group Code |
Region |
Dispensing Unit Code |
Start Date |
End Date |
Rank |
|---|---|---|---|---|---|
LG_1 |
USA |
Kit_A, Kit_B |
|
01-Dec-2023 |
1 |
LG_2 |
GBR, USA |
Kit_A, Kit_B |
01-Oct-2023 |
|
2 |
LG_3 |
DEU |
Kit_C |
|
|
|
Columns in RED are mandatory attributes.
Column Definitions
Label Group Code
Defines the label group. Label group codes have to be unique within a single scenario specification.
Region
Defines the region(s) to which a label group is associated. Must match an existing region specified in the Network Table.
Dispensing Unit Code
Defines which Dispensing Units will use the Label Group. This allows for the same Dispensing Unit to have different Label Groups, if needed. The Label Group requirements can be defined for the entire study or may change over time.
Example 1: Kit A has a global booklet label while Kit B requires single panel labels per country.
Example 2: The label group for both kit types changes after a period of time. Japan requires a separate, single-panel label at the start of the study and then is approved to be included in ‘ROW2’ booklet label after a period of time.
Start Date
Designates when the specified label group is available for dispensing in the defined region(s).
End Date
Designates when the specified label group can no longer be dispensed in the defined region(s).
Rank
Specifies which label group is to be filled first in scenarios where dates or regions overlap. Accepts positive integers only, a label group of rank of 1 will be fulfilled first, 2 will be second, and so on.
If there is an overlap in start and end dates between any two or more label groups that fulfill the same region, rank values are required to specify the order in which label groups should be used in the Production Plan and Trial Supply Projection report.