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Packaging lot

A lot is a batch of items (drugs) with mutual characteristics.

A packaging lot is a batch of items that can belong to different product units but are collected into one package to be released (shipped) to the depot or for other logistic purposes. Using packaging lots with their unique lot numbers gives depots and sites the ability to differentiate between different batches of products to track, for instance, release and expiration dates or other useful information.

All the packaging lots previously created in the IWRS application can be reviewed in the Packaging Lot module and have the attributes displayed and explained in the following table.

Packaging lot list
Figure 1. Packaging lot list

Column

Details

Lot Number

Represents the lot number that is an active link leading to the lot details where you can also add items to the lot.

Expiration Date

Represents the default expiration date of the packaging lot. There can be more custom expiration dates managed from lot details.

Requires Country Release

Represents if this lot has been set for release only in a specific country/region (Yes or No).

Release Country/Region

Represents the country or region in which the lot must be released if the Requires Country Release value is Yes.

Created Date

Represents the creation date of the lot.

Total Items #

Represents the total number of items in a lot.

Draft Items #

Represents the number of draft items in a lot. The items are considered draft if they have not been released yet.

Released Items #

Represents the number of released items in a lot.

In IWRS, the Packaging Lot feature is designed to help you create, release, and otherwise manage the item lots via the following available actions:

In this section:

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 product unit in the IWRS system is item unit.

A warehouse that is used to store and distribute items (drugs) to another destination (other depots or sites).

A unique identification number assigned to each lot of items via the IWRS system.

In a clinical trial, a location where the subject treatment and drug dispensation occur. It can be a hospital, a private laboratory, or other institutions.