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Lot management

A lot is a batch of items (drugs) that are produced at one time and have common characteristics. In IWRS, you can differentiate between two types of lots used for different purposes.

  • Packaging lot: a batch of items collected into one package to be released (shipped) to the depot or site or for other logistic purposes. Using packaging lots with their unique identifiers gives depots and sites the ability to differentiate between different batches of drugs to track, for instance, release and expiration dates or other useful information.

  • Manufacturing lot: a batch of items produced together at one time and belonging to the same product unit. This information is not used for logistics or system processes but exists in IWRS for the traceability of manufactured drugs.

Important

Since the drugs are manufactured in a certain lot and then packaged into another one for shipment purposes, in IWRS, the same item can exist both in Manufacturing Lot and Packaging Lot and have both manufacturing and packaging lot numbers.

In this section:

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

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.

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.