Glossary

Verifiable information or records pertaining to the quality of an item or service or to the existence and implementation of a quality system element, which is based on visual observation, measurement or test.

Use of a medicine outside the scope of regulatory authorization.

Those pharmacopoeias recognized by the national regulatory agencies (e.g. national pharmacopoeia (if applicable), the British Pharmacopoeia, the European Pharmacopoeia, The International Pharmacopoeia, the Japanese Pharmacopoeia and the United States Pharmacopeia).

The study carried out by the manufacturer on production batches according to a predetermined schedule in order to monitor, confirm and extend the projected re-test period (or shelf life) of the active pharmaeutical ingredient, or confirm or extend the shelf life of the finished pharmaceutical product.

The component or components being referred to function as normally expected. More explicitly with respect to the appliance, the cooling circuit functions as required by the thermostat.

In relation to replaceable batteries operating life the period following initial activation of the device until the battery is expected to fail. In the case of devices with non-replaceable batteries the period is measured from the date of delivery to the purchaser, rirrespective of whether the device is activated on that date.

Usually refers to an OSD plant that manufactures medicinal products such as tablets, capsules and powders to be taken orally.

Product licensed and approved by a stringent regulatory authority on the basis of a full dossier with comprehensive data on non-clinical and clinical studies.

An “other observation” observed by the WHO inspection group during inspection of a manufacturing site, quality control laboratory or contract research organization indicates that a minor lapse or minor deviation from good manufacturing practice has been observed in the case of a manufacturing site, and from good clinical practice in the case of a contract research organization.

A situation where an electrical device is subjected to a greater electrical load than that for which it was designed. Results in larger than design electric current passing through conductors, leading to excessive generation of heat, and the risk of fire or damage to equipment.