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Create new manufacturing lot

In a clinical trial, the investigational product is released in lots that have their specific numbers and expiry terms. A manufacturing lot is a batch of items produced together at one time and belonging to the same item unit. Manufacturing lot information is not used for logistics or system processes but exists in IWRS for the traceability of manufactured drugs.

In IWRS, you can manually create manufacturing lots and add items to them as per your business needs.

To create a new manufacturing lot

  1. In the IWRS application header, select the TREATMENT DESIGN tab.

  2. In the left pane, select the Lot subtab.

    Accessing lot subtab
    Figure 1. Accessing lot subtab

  3. On the page that opens, from the contents panel, select the Manufacturing Lot tab.

  4. Under the Manufacturing Lot tab, from the workspace toolbar, select New Item image58.jpg.

    Adding manufacturing lot
    Figure 2. Adding manufacturing lot

  5. In the Add dialog that appears, start configuring your lot by setting the preferences as described in the following table.

    Configuring manufacturing lot details
    Figure 3. Configuring manufacturing lot details

    Tip

    In the following table, mandatory elements are marked with an asterisk (*).

    Element

    Details

    Manufacturing Lot Number*

    Enter a unique manufacturing lot number.

    Item Unit*

    Select the item unit to which the manufactured items from the lot belong.

    If there is no item unit that you need, you can add a new item unit to IWRS manually and then return to creating your manufacturing lot.

    Expiration Date

    Select the date picker date_picker_calendar_gray_small.jpg and select the expiry date of the items in the manufacturing lot.

    This date exists in the system for the supply manager to check the item expiration date. However, for the system processes—for instance, the lot expiration alert setting—the packaging lot expiration date is accounted for.

    Manufacturing Country

    Select the country where the drugs from this lot are manufactured.

    Description

    Enter a description to provide some additional details about the lot.

    SAVE

    Select save_button_red.png to create your manufacturing lot.

    CANCEL

    Select cancel_button_white_blue.png to stop creating a new lot, close the form, and return to the manufacturing lot list. In such a case, no changes are saved.

Once saved, a new manufacturing lot is created.

In this section:

A batch of items (drugs) that are produced at one time and have common characteristics, such as, for instance, expiration date. In IWRS, there are two types of item lots—packaging lot and manufacturing lot.

An investigational product that is used in a study. In eClinical, it can be viewed as an equivalent to a drug name to distinguish items at all stages of their lifecycle—manufacturing, shipment, dispensation to subjects, or else.

Another name for the item unit in the IWRS system is product unit.