Glossary

The “quality level that is the worst tolerable” according to ISO 2859-1. It represents the maximum number of defective units, beyond which a batch is rejected. Suppliers can set different AQLs for critical, major and minor defects. The actual AQL set depends on the lot size, the inspection level and the AQL appropriate for the situation.

The acceptable temperature range for storing vaccine is +2°C to +8°C. However, transient excursions outside this range will be tolerated, within the following limits:

no excursion exceeding +20°C for any amount of time (after the appliance is turned on and initially cools)

no excursion below -0.5°C for any amount of time

no excursion below 0°C for longer than 1 hour

following an excursion below 0°C, the appliance must return to safe operating temperature (i.e, consistently between +2°C and +8°C) within 2 hours; this duration will be measured from the moment the temperature drops below 0°C and up until it returns to +2°C

the calculated mean kinetic temperature (MKT) must remain within +2°C to +8°C when the default activation energy is set at 83.144 kJ per mol and when calculated over the duration of any testing that requires maintaining this range.

Measurable terms under which a test result will be considered acceptable.

Any cooling or other heat transfer that is powered or driven by anything besides the spontaneous, passive transfer of heat due to temperature differential and related passive effects such as natural convection.

A raw material, intermediate or an API that is used in the production of an API and that is incorporated as a significant structural fragment into the structure of the API. An API starting material can be an article of commerce, a material purchased from one or more suppliers under contract or commercial agreement or produced in-house.

A raw material, intermediate, or an API that is used in the production of an API and that is incorporated as a significant structural fragment into the structure of the API. An API starting material can be an article of commerce, a material purchased from one or more suppliers under contract or commercial agreement, or produced in-house.

The APIMF procedure is one of four ways to provide information on the preparation control and stability of an API intended for use in a prequalified finished pharmaceutical product (FPP). The other three options are: the use of a prequalified API; use of a certificate of suitability (known as a CEP) issued by the European Directorate for the Quality of Medicines; or the submission of complete API information as part of the FPP dossier.

A time-temperature sensitive region on time-temperature indicators whose appearance matches the stability profile of the vaccine that the indicator is monitoring.

A substance or combination of substances used in conjunction with a vaccine antigen to enhance (for example, increase, accelerate, prolong and/or possibly target) or modulate a specific immune response to the vaccine antigen in order to enhance the clinical effectiveness of the vaccine.

An AMC is a legally-binding agreement for an amount of funds to subsidize the purchase, at a given price, of an as yet unavailable vaccine against a specific disease causing high morbidity and mortality in low-income countries.

An electric current that reverses its direction at regularly recurring intervals the value of which varies as a sine wave.

The yearly review which all prequalified immunization devices are required to pass in order to remain on the WHO list of prequalified immunization devices. 

The active ingredient in a vaccine against which the immune response is induced.Antigens may be: (a) live attenuated or inactivated preparations of bacteria, viruses or parasites; (b) crude cellular fractions or purified antigens, including recombinant proteins (that is, those derived from recombinant DNA expressed in a host cell); (c) polysaccharides and conjugates formed by covalent linkage of polysaccharides to components such as mutated or inactivated proteins and/or toxoids; (d) synthetic antigens; (e) polynucleotides (such as plasmid DNA vaccines); or (f) living vectored cells expressing specific heterologous antigens. Also referred to as “immunogen” in other documents. Also used to describe (a) a component that may undergo chemical change or processing before it becomes the antigen or active ingredient used to formulate the final product (also referred to as an “intermediate” in other documents); or (b) an active ingredient present in an unmodified form in the final product (also referred to as “drug substance” or “active substance” in other documents). For example, in this document the term “antigen” applies, in the case of a polysaccharide conjugated vaccine, to the polysaccharide intermediate as well as to the conjugated polysaccharide that will not undergo further modification prior to formulation.

Any powered device intended to provide cooling for vaccine storage or transport.

The person or entity who, by the deadline mentioned in the invitation, submits an expression  of interest (EOI) to participate in this procedure in respect of the product(s) listed in the invitation, together with the required documentation on such product(s).

A person or organization approved by the legal manufacturer or reseller as a competent installer of cold chain equipment or system components and who has been appointed by the employer to carry out the installation of the system.

Time in hours for which a solar-powered appliance, monitoring device or walk-in cold room/freezer room can maintain minimum specified performance under low solar power conditions (rain).

Time in hours that a solar powered refrigerator, or combined refrigerator and water-pack freezer can maintain the vaccine load between +2°C and +8°C under low solar power conditions (rain).