Glossary

Data integrity is the degree to which data are complete, consistent, accurate, trustworthy and reliable and that these characteristics of the data are maintained throughout the data life cycle. The data should be collected and maintained in a secure manner, such that they are attributable, legible, contemporaneously recorded, original or a true copy and accurate. Assuring data integrity requires appropriate quality and risk management systems, including adherence to sound scientific principles and good documentation practices.

The period following the deactivation of a temperature recording device using the 'stop’ function, during which it must be possible to recover the data recorded during the recording period.

A date fixed for the individual batch, indicating the completion date of the manufacture. It is normally expressed by a month and a year. The date of the release analysis may be taken as a date of manufacture, provided that the period between the beginning of production and the release of the product is not longer than one-twentieth of the shelf life.

Specific load(s) matched to the energy harvest control (EHC) and supplied by the legal manufacturer/reseller. The defined load(s) would be permanently connected to the EHC or would connect to the EHC with a unique, non-standard electrical connector to restrict the addition of undefined loads with standard electrical connectors.

Departure from an approved instruction or established standard.

An electric current flowing in one direction.

The physical form in which a pharmaceutical product is presented by the manufacturer (form of presentation) and the form in which it is administered (form of administration). Also sometimes referred to as “pharmaceutical form”. Examples include tablet, capsule, elixir, injection, suppository.

Any substance or pharmaceutical product for human or veterinary use that is intended to modify or explore physiological systems or pathological states for the benefit of the recipient. The terms drug, medicine and pharmaceutical product are commonly used interchageably.

Detailed information concerning a specific facility, process or product submitted to the medicines regulatory authority, intended for incorporation into the application for marketing authorization.

A pharmaceutical product type that contains a drug substance, generally in association with excipients. This refers to a dosage form in the final immediate packaging intended for marketing.

The active pharmaceutical ingredient and associated molecules that may be subsequently formulated, with excipients, to produce the drug product. Any substance or mixture of substances intended to be used in the manufacture of a drug (medicinal) product and that, when used in the production of a drug, becomes an active ingredient of the drug product. Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure and function of the body.