Manufacturers of medicinal products, pharmaceutical importers, contractors, wholesalers, and community and hospital pharmacies need to ensure sensitive products are stored in temperature-controlled rooms, such as cold rooms, refrigerators, and freezers that comply with specific requirements. Material handling, transport, and delivery must also be managed according to specific regulations.
To ensure compliance with the Good Trade and Distribution Practice (GTDP) of pharmaceutical starting materials, Good Manufacturing Practices (GMP), and Good Distribution Practice (GDP), Life Sciences Supply Chain Management allows to configure, approve and activate storage conditions for items, warehouses, and locations (for example, temperature and humidity ranges).
Storage condition variables
The controlled storage condition variables, such as temperature and humidity, can be set up in Inventory management > Setup > Storage conditions > Storage conditions variables. For each variable, the following parameters can be specified:
Storage condition variable
Description
Variable type (Enumerate, for variables with a fixed list of values, or Fraction, for variables with a validity range)
Unit (mandatory for variables of type Fraction)
Note
In the case of Enumerate variables, the possible options must be listed in the Variable values form, which can be opened by clicking the Variable values button (for example, Yes and No).
Example
It is possible to create a variable that controls the temperature as follows:
Storage condition variable: “Temp”
Description: “Temperature”
Variable type: Fraction
Unit: “°C”
It is possible to create a variable that controls the light exposure as follows:
Storage condition variable: “Light”
Description: “Light exposure”
Variable type: Enumerate
Variable values:
“Yes”
“No”
Storage conditions master
Once the controlled variables have been defined, authorized users can create, approve and activate the storage conditions in Inventory management > Setup > Storage conditions > Storage conditions.
Users can assign one or more storage condition variables to each storage condition with the respective validity conditions. A range must be defined for the Fraction variables, while a value in the list must be selected for the Enumerate variables.
Example
Create the following storage condition to control a temperature range of 2-8 °C and the light exposure:
Storage condition variable | Type | Unit | Min | Max | Variable value |
|---|---|---|---|---|---|
Temp | Fraction | °C | 2 | 8 | – |
Light | Enumerate | – | – | – | Yes |
In addition, for each storage condition variable, the following parameters can be specified:
Skip check: Used to define whether the control on inventory movements should be omitted for a selected storage condition variable (for example, if the light exposure does not need to be controlled since no separate dark location is configured).
Print on label: Used to define whether a storage condition text should be printed on labels.
Label: Used to define the default text to be printed on labels (for example, “Store at 4 °C”).
Storage conditions must be approved by clicking the Approve button in the Storage conditions form to allow their assignment to items or locations.
Users can specify if the storage condition approval should be secured via electronic signature by enabling the Signature required parameter for the “Approve storage conditions” requirement in the Electronic signature requirements form (Organization administration > Setup > Electronic signature > Electronic signature requirements).
Storage conditions assignment to items, warehouses, or locations
Authorized users can associate an approved storage condition to:
Released products, by clicking the Manage inventory > Storage > Storage conditions button in the Released products form (Product information management > Products > Released products). The item storage condition must be approved and activated to be effective. Multiple storage conditions can be approved at the same time, but only one can be active for the item.
Batches, by filling the Storage condition field in the Quality management FastTab of the Batches form (Inventory management > Inquiries and reports > Tracking dimensions > Batches). Whenever a new batch is manually or automatically created, it will inherit the active storage condition of the corresponding item at the time of the batch creation. Users can manually change the batch storage condition by selecting among the item’s approved storage conditions.
Sub batches, by filling the Storage condition field in the Quality management FastTab of the Sub batches form (Inventory management > Inquiries and reports > Tracking dimensions > Sub batches). Whenever a new sub-batch is manually or automatically created, it will inherit the active storage condition of the corresponding item at the time of the sub-batch creation. Users can manually change the sub-batch storage condition by selecting among the item’s approved storage conditions.
Warehouses, by clicking the Warehouse > Set up > Storage conditions button in the Warehouses form (Inventory management > Setup > Inventory breakdown > Warehouses or Warehouse management > Setup > Warehouse setup > Warehouses). Storage conditions for warehouses can be approved and activated by clicking the Approve and Activation buttons, respectively. A storage condition can be assigned to the entire warehouse only if the Storage conditions > Enable location parameter is disabled in the Warehouses form. Multiple storage conditions can be approved for the warehouse, but only one can be active simultaneously.
Locations, by clicking the Storage conditions button in the Locations form (Warehouse management > Setup > Warehouse setup > Locations) or the Inventory location > Warehouse items > Storage conditions button in the Inventory location form (Inventory management > Setup > Inventory breakdown > Inventory locations). A storage condition can be assigned to a location only if the Storage conditions > Enable location parameter for the parent warehouse is enabled in the Warehouses form. Multiple storage conditions can be approved for the location, but only one can be active simultaneously.
Users can specify if the approval and activation of storage conditions for items, warehouses, and locations should be secured via electronic signature by enabling the Signature required parameter for the following requirements in the Electronic signature requirements form (Organization administration > Setup > Electronic signature > Electronic signature requirements):
Approve storage conditions for items
Activate storage conditions for items
Approve storage conditions for warehouses/locations
Activate storage conditions for warehouses/locations
Storage conditions verification upon inventory movements
Inventory transactions to specific warehouses/locations may be restricted according to the material storage condition.
Users can define, per each item, whether the system shall allow the material movement to warehouses/locations that do not support its storage condition. The proper Approved storage condition check method value must be selected in the Item check groups form (Inventory management > Setup > Inventory > Item check groups). It is possible to choose among the following options:
No check – During the inventory transaction, the system will not check if the storage conditions of the warehouse/location are suitable for the item.
Warning only – During the inventory transaction, the system will check if the storage conditions of the warehouse/location are suitable for the item. If the combination is not valid, the system will return a warning message, but the user will be able to complete the transaction (that is, the product should preferably be stored in warehouses/locations with appropriate storage conditions).
Not allowed – During the inventory transaction, the system will check if the storage conditions of the warehouse/location are suitable for the item. If the combination is not valid, the system will return an error message and the transaction will be aborted (that is, the product can only be stored in warehouses/locations with appropriate storage conditions).
The selected value is inherited by items associated with the item check group. Users can override the default value by modifying the Approved storage condition check method field in the Manage Inventory tab of the Released product details form (Product information management > Common > Released products > Released product details).
During the receipt of an item into a specific warehouse/location, the system will check whether the control on storage conditions is active (Approved storage condition check method set to Not allowed or Warning only). If so, the system will compare the storage condition of the batch/sub-batch with the active storage condition of the warehouse/location and return an error or warning message, according to the item configuration, if there is a mismatch.
The control is performed at different levels:
First, the system will check whether the storage condition ID in the header of the Storage conditions forms for the batch/sub-batch corresponds to the storage condition ID in the header of the Storage conditions form for the warehouse/location.
If the storage condition ID is different, the system will compare the lines of the Storage conditions form for the batch/sub-batch with the lines of the Storage conditions form for the warehouse/location. If all the conditions at the batch/sub batch level are satisfied by the storage conditions at the warehouse/location level, the system will not return any warning or error message. On the other hand, if at least one condition at the batch/sub batch level is not satisfied by the location/warehouse, the system will return a warning or error message.
Example
Storage condition at the batch “BN001” has lines as follows:
Storage condition variable | Type | Unit | Min | Max | Variable value |
|---|---|---|---|---|---|
Temp | Fraction | °C | 2 | 8 | – |
Light | Enumerate | – | – | – | Yes |
Storage condition at location “LOC-01” has lines as follows:
Storage condition variable | Type | Unit | Min | Max | Variable value |
|---|---|---|---|---|---|
Temp | Fraction | °C | 2 | 8 | – |
Batch “BN001” is not compatible with location “LOC-01” as the condition on the “Light” variable is not satisfied.
Storage condition at location “LOC-02” has lines as follows:
Storage condition variable | Type | Unit | Min | Max | Variable value |
|---|---|---|---|---|---|
Temp | Fraction | °C | 15 | 25 | – |
Light | Enumerate | – | – | – | Yes |
Batch “BN001” is not compatible with location “LOC-02” as the condition on the “Temp” variable is not satisfied.
Storage condition at location “LOC-03” has lines as follows:
Storage condition variable | Type | Unit | Min | Max | Variable value |
|---|---|---|---|---|---|
Temp | Fraction | °C | 3 | 7 | – |
Humid | Fraction | % | 80 | 100 | Yes |
Light | Enumerate | – | – | – | Yes |
Batch “BN001” is compatible with location “LOC-03” as both the conditions on “Light” and “Temp” variables are satisfied.
Storage conditions mismatch report
Users can generate a report that lists all batches/sub-batches stocked in inventory dimensions whose storage conditions are not appropriate by going to Inventory management > Inquiries and reports > Storage conditions > Storage condition mismatch.
Enable the required Parameters to identify the inventory dimensions (for example, Site, Warehouse, Sub batch number, etc.) to be displayed in the report. The Location and Batch number dimensions are automatically enabled and mandatory.
The data in the report can be filtered or sorted by defining a query, which can be opened by clicking the Filter button in the Records to include section.