Glossary

Process of identifying a pharmaceutical product including the following information, as appropriate: name of the product; active ingredient(s), type and amount; batch number; expiry date; special storage conditions or handling precautions; directions for use, warnings and precautions; names and addresses of the manufacturer and/or the supplier.

Information to the user provided on the package label or in the patient information leaflet.

A LIF is a document prepared by the laboratory. It contains specific and factual information about the operations carried out at the named site and any closely integrated operations of the laboratory. If only some of the operations are carried out on the site, the LIF needs to describe only those operations, e.g. sampling, chemical analysis or stability testing.

The natural or legal person with responsibility for the design, manufacture, packaging and labelling of a product or device before it is placed on the market under the person's own name, irrespective of whether these operations are carried out by that person or on their behalf by a third party. A legal manufacturer may commonly contract another company to manufacture products or devices sold under the legal manufacturer’s name. A manufacturer that is contracted in this way is typically known as an original equipment manufacturer (OEM).

An individual or a corporate entity possessing a marketing authorization for a pharmaceutical product.

A commercial entity, licensed to act on behalf of a legal manufacturer, and which carries product liability and warranty responsibilities no less onerous than those carried by the legal manufacturer.

Any end-use device in an electrical circuit (other than the primary appliance and energy harvest control) that can consume power when the electrical circuit is energized. Two categories of electrical loads are considered: defined loads and undefined loads.

Experiments on the physical, chemical, biological, biopharmaceutical and microbiological characteristics of an active pharmaceutical ingredient or finished pharmaceutical product, during and beyond the expected shelf life and storage periods of samples under the storage conditions expected in the intended market. The results are used to establish the re-test period or the shelf life, to confirm the projected re-test period and shelf life, and to recommend storage conditions.

For the purpose of WHO performance evaluation of an in vitro diagnostic, a lot is defined as 'The amount of material that is uniform in its properties and has been produced in one process or series of processes. The material can be either starting material, intermediate material or finished product.” Furthermore, the two lots must be sourced from a representative production run and not produced especially for the purpose of the WHO performance evaluation.