Glossary

A key strategic document that contains a detailed description of desirable future product design characteristics, features or functions. It explains the reason for each desirable characteristic and states the date by which the feature must be included in products seeking to achieve or to maintain prequalified status. A TPP captures user needs via inputs and product feedback from the operating environment, guiding product development so that it responds to needs that have arisen in that operating environment. TPPs are intended to stimulate further feedback and dialogue with product manufacturers. They are not intended to be proscriptive about how product user needs should be met, but rather to stimulate new ideas and solutions. They do not impose any implicit or explicit obligation on manufacturers to achieve all of the desirable product characteristics. For example, during the dialogue process it may emerge that some of these characteristics are technically difficult to achieve or may drive up costs. In such circumstances, these characteristics may appear as optional performance requirements in the final specification. Manufacturers that are able to satisfy these optional requirements may be at a competitive advantage and serve to incentivize to other manufacturers to reach that same level of performance.

Temperate zone units must operate within the proper storage temperatures at a steady +32°C ambient temperature and over a +32°C/+15°C day/night cycling temperature range.

The time it takes for temperatures within an appliance to reach the acceptable temperature range and attain full holdover or autonomy.

A corrugated cardboard or fibreboard box which contains a number of individual secondary packs. Cartons of this type are increasingly being used to store and to distribute vaccine.

Commercially prepared reagent sets, with accessory devices, containing all of the major componentsand literature necessary to perform one or more designated diagnostic tests or procedures.

Therapeutic activity refers to the successful prevention, diagnosis and treatment of physical and mental illnesses; improvement of symptoms of illnesses; as well as beneficial alteration or regulation of the physical and mental status of the body and development of a sense of general well-being.

Two pharmaceutical products are considered to be therapeutically equivalent if they are pharmaceutically equivalent or pharmaceutical alternatives and, after administration in the same molar dose, their effects, with respect to both efficacy and safety, are essentially the same when administered to patients by the same route under the conditions specified in the labelling. This can be demonstrated by appropriate equivalence studies, such as pharmacokinetic, pharmacodynamic, clinical or in vitro studies.

A device that indicates when vaccines have exceeded a specified threshold temperature. These may be chemical or electronic in operation.

Traceability aims at ensuring that the results of laboratory measurements using procedures of lower metrological order are reproducible and scientifically acceptable by referring to an internationally agreed denominator by means of a reference procedure of highest metrological order and/or a primary reference material.

Defining policies and procedures in writing and publishing the written documentation, and giving reasons for decisions to the public.