Glossary

A preparation containing antigens capable of inducing an active  immune response for the prevention, amelioration or treatment of infectious diseases.

The relative reduction in disease incidence or severity in vaccinated individuals compared to unvaccinated individuals measured in a randomized, placebo-controlled clinical trial. In the context of these Guidelines, vaccine efficacy has a broad meaning and relates to all clinical data obtained to ensure vaccine efficacy, immunogenicity or field effectiveness.

The volume of the vaccine storage compartment measured with the full number of coolant-packs in place. Capacity will be published as length, width and height in centimetres and volume in litres. If the volume is not rectangular in horizontal cross-section, the capacity may be published as area in square centimetres, height in centimetres and volume in litres.

The compartment within an appliance which is designated by the legal manufacturer as suitable for storing vaccine.

A label containing time-temperature sensitive material which is placed on a vaccine vial to register cumulative heat exposure over time. Vaccines produced by different manufacturers may have different heat stability characteristics and may therefore be assigned different VVMs based on a vaccine’s thermostability profile as determined by laboratory testing.

Action of proving, in accordance with the principles of good manufacturing practice/good clinical practices/good laboratory practices, that any procedure, process, equipment, material, activity or system actually and consistently leads to the expected results (see also qualification).

A laboratory test device to simulate a variety of secondary loads operating on an adjustable range of direct current (DC) electricity input.

A change to any aspect of a pharmaceutical product, including but not limited to, the change of use of a starting material, a change to formulation, method and site of manufacture, specifications for the finished product and ingredients, container and container labelling and product information.

Describes in detail how the performance of a product or device will be tested or otherwise evaluated as part of the PQS???? product prequalification procedure. Each performance specification is accompanied by at least one corresponding verification protocol.

A small container for parenteral medicinal products, with a stopper and overseal; the contents are removed after piercing the stopper. Both single-dose and multi-dose types exist.