For some products, the calculation of batch dates might depend on factors such as the type of container in which the material is stored, the storage conditions (for example, temperature, light, humidity), or the synthetic route used to manufacture that product. These factors can impact the shelf life of a batch (positively or negatively), and therefore, they must be taken into account when calculating the shelf-life dates.
Life Sciences Supply Chain Management allows users to define custom rules for calculating batch dates based on a combination of storage conditions, container configurations, and synthetic routes. For example, if the shelf life of a product is deeply affected by temperature, it is possible to define a longer shelf life period if the batch is stored in a fridge (storage condition 2°C-8°C) and a shorter shelf life period if the batch is stored outside of a refrigerated area (storage condition Ambient).
Enable using such date calculation rules by setting the Enable date calculation rules parameter to Yes for the item (Product information management > Products > Released products > Manage inventory FastTab). When the parameter is enabled, it is possible to define the item-specific rules by clicking the Date calculation rules button in the Manage inventory tab of the Released products form.
For each rule, the user must define the following information:
Date calculation rule: and ID for the rule.
Storage condition: the storage condition for which the rule applies. If the specific rule is not affected by storage conditions, it is possible to select All in the Storage condition code field (that is, the rule is valid for all storage conditions).
Container configuration: the container configuration for which the rule applies. If the specific rule is not affected by container configurations, it is possible to select All in the Container configuration code field (that is, the rule is valid for all container configurations).
Synthetic route: the synthetic route for which the rule applies. If the specific rule is not affected by synthetic routes, it is possible to select All in the Synthetic route code field (that is, the rule is valid for all synthetic routes).
Period type and Periods in days: define the duration of each shelf-life period. It is possible to calculate the following periods:
Shelf advice period, used to calculate the Shelf advice date.
Best before period, used to calculate the Best before date.
Shelf life period, used to calculate the Expiration date.
Destroy by period, used to calculate the Destroy by date.
Period after opening, used to calculate the new expiration date after container opening.
Note
The restrictions on shelf-life dates are applied to the date calculation rules.
Fixed date: defines the criteria to round the periods when calculating the batch dates. The following options can be selected:
Fixed: fixed day of the month, defined in the Date field (for example, always rounded to the 15th of the month).
Last day of the previous month.
Last day of the current month.
First day of the following month.
N/A: no rounding rule is applied.
A date calculation rule must be approved by clicking the Approve button and activated by clicking the Activation button. When activating the rule, the user must define the starting date of the activation period (that is, From date field). The approval and activation step can be secured by electronic signature.
Note
It is not possible to activate date calculation rules with overlapping conditions for the same period. For example, if a rule is valid for 2°C-8°C storage condition and Carton container configuration, it is not possible to create a rule for All storage conditions and Carton container configuration.
Whenever a batch is created (either manually or automatically), the system verifies if the Enable date calculation rules parameter is enabled for the item:
If enabled, the system verifies if there is an approved and active rule for the combination of storage conditions, container configuration and synthetic route of the batch.
If yes, the system calculates the batch dates based on the applicable date calculation rule.
If not, a warning is displayed, and the system calculates the batch dates based on the periods in days defined in the item master.
If disabled, the system calculates the batch dates based on the periods in days defined in the item master.
It is possible to apply the date calculation rules only on some dates. For example, the storage condition affects the shelf life date while the other dates are unaffected (that is, the period in days is constant). In this case, only the Shelf life period is defined in the date calculation rules. The other dates are assigned based on the periods in days defined in the item master.
In the case of sub-batch managed items, the dates are assigned to the sub-batches following the batch rules.
A synthetic route can be assigned to a batch/sub-batch only if a date calculation rule is active for that specific storage condition, container configuration, and synthetic route combination. If not, an error message is displayed, and the synthetic route value is not saved. Users can override this validation process on the Synthetic route field by enabling the Disable validation on synthetic route parameter ( Inventory management > Setup > Inventory and warehouse management parameters > General Tab). If the parameter is enabled, users can assign a synthetic route to a batch/ sub-batch even if there is no active date calculation rule for that specific storage condition, container configuration, and synthetic route combination. A warning message is displayed to notify that there is no active date calculation rule, but the synthetic route value is correctly saved.
If the storage conditions and/or container configuration and/or synthetic route of a batch/sub-batch are modified, it is possible to click the Update batch dates/Update sub batch dates buttons (in the Reset tab of the Batches and Sub batches forms) to trigger a dates recalculation based on the new conditions. When updating dates via the Update batch dates/Update sub batch dates buttons, the system recalculates all the dates specified in the date calculation rule, even if some of them are fixed (for example, Expiration date set to Vendor expiry date, Use as expiration date parameter enabled). An Infolog specifies whether each date was calculated according to a date calculation rule or according to the released product details. A warning is displayed if no rule is available for the new conditions, and the dates are recalculated according to the periods defined in the item master.
Additionally, it is possible to easily inquiry the list of batches and sub-batches that fall under the conditions of a selected date calculation rule by clicking the Batches and Sub batches buttons in the Date calculation rules form (Product information management > Products > Released products > Manage inventory tab > Date calculation rules button).
Note
The behaviors described above apply only to items that have the Enable date calculation rules parameter enabled.