Glossary

A water-pack frozen to a temperature between -5°C and -25°C before use, to the point where there is no remaining liquid water. Ice-packs can be conditioned by letting them warm to 0°C for use with transport of freeze-sensitive vaccines.

The maximum number of fully frozen water-packs that can remain fully frozen at the end of water-pack storage compartment testing over a multi-day period.

An instrument or apparatus adapted for a specific purpose related to immunization. WHO-prequalified medical devices include temperature monitoring devices, single use injection devices and therapeutic injection devices.

Item of equipment created for use in immunization programmes. WHO-prequalified products include refrigerators and freezers and other vaccine storage products, temperature controlled vaccine transport and delivery products, waste disposal products and cold chain accessories.

The ability of a substance to trigger an immune response or reaction (e.g. development of specific antibodies, T-cell response, allergic or anaphylactic reaction). 

A sudden, non–power frequency change in the steady-state condition of voltage, current or both that is unidirectional in polarity – either primarily positive or negative. Often characterized by extremely high voltages that can cause high levels of current in an electrical circuit for periods ranging from a few millionths to a few thousandths of a second.

Any component present in the drug substance or drug product that is not the desired product, a product-related substance, or excipient including buffer components. It may be either process- or product-related.

A medical device, whether used alone or in combination, intended by the manufacturer for the in vitro examination of specimens derived from the human body solely or principally to provide information for diagnostic, monitoring or compatibility purposesIVDs include reagents, calibrators, control materials, specimen receptacles, software, and related instruments or apparatus or other articles, and are used, for example, for the following test purposes: diagnosis, aid to diagnosis, screening, monitoring, predisposition, prognosis, prediction, determination of physiological status.

Communication by letter, fax or email.

The time in hours during which all points in the vaccine storage compartment remain between +2°C and +8°C, at a constant ambient test temperature of +43°C, after all external power inputs have been disconnected or switched off. This may include both passive as well as active cooling if powered by internal sources integrated into the appliance, e.g. an integrated battery. Independence is distinct from holdover time in that it may include both actively powered and passive cooling, while holdover time includes only passive, thermal cooling capacity.

Generally the pharmaceutical product which was first authorized for marketing (normally as a patented product) on the basis of documentation of efficacy, safety and quality according to requirements at the time of the authorization. When a substance has been available for many years, it may not be possible to identify an innovator pharmaceutical product.

An inspection observation is a finding or a statement of fact made during an inspection and substantiated by objective evidence. Such findings may be positive or negative. Positive observations should take the form of a description of the processes that the firm is carrying out particularly well and that may be considered examples of particularly good practice. Negative observations are findings of non-compliance with requirements.

The complete cold room or freezer installation described in WHO/PQS/E001/CR-FR01.4 and in the companion WHO/PQS/E001/CR-FR01-VP2 and WHO/PQS/E001/CR-FR01-VP.4 documents, together with any other employer’s requirements documentation issued for a specific installation or installations. Including voltage stabilizers and standby generators where these are listed in the employer’s requirements.

The person who installs the solar power system and associated appliance on behalf of the procurement agency.

A person or organization who has been appointed by the employer to carry out the installation of a device or system.

General information card or sheet providing all information necessary for correct use of the device.

The objective intent of the manufacturer regarding the use of a product, process or service as reflected in the specifications, instructions and information provided by the manufacturer. Aspects that are considered in the intended use of an in vitro diagnostic include:

what is detected

its function (e.g. screening, monitoring, diagnosis or aid to diagnosis)

the specific disorder, condition or risk factor of interest that it is intended to detect, define or differentiate

whether it is automated or not

whether it is qualitative or quantitative

the type of specimen(s) required (e.g. serum, plasma, whole blood, tissue biopsy, urine)

testing population

the intended user (e.g. lay person, highly trained laboratory professional, minimally trained health care worker, self-testing)

the intended setting of use (e.g. point of care, reference or diagnostic laboratory setting, primary health care setting).

An interchangeable pharmaceutical product is one which is therapeutically equivalent to a comparator product and can be interchanged with the comparator in clinical practice.

This can be a material produced during steps of the processing of an active pharmaceutical ingredient (API) that undergoes further molecular change or purification before it becomes an API. Intermediates may or may not be isolated, or a material produced during steps in the manufacture of a vaccine that undergoes further processing before it becomes the final product. See also antigen.

Stores that keep and distribute vaccines which are neither at the primary vaccine store nor at the final service delivery level. Such stores are typically located in a regional or district centre.

ICRSs are primary chemical reference substances established on the advice of the WHO Expert Committee on Specifications for Pharmaceutical Preparations. They are supplied primarily for use in physical and chemical tests and assays described in the specifications for quality control of drugs published in The International Pharmacopoeia or proposed in draft monographs. They may be used to calibrate secondary standards.

The shortened scientific name based on the active ingredient. WHO is responsible for assigning INNs to pharmaceutical substances.

Any pharmaceutical product (see definition) or placebo being tested or used as a reference in a clinical trial.

Invitation calling upon interested parties (e.g. manufacturers or other applicants) to submit an expression of interest (EOI) to WHO by a specified deadline for the purpose of participating in the WHO prequalification procedure in respect of the product(s) listed/laboratories defined in the invitation. Such an EOI should be accompanied by the required documentation on the product(s) in question.

Invitation calling upon interested parties (e.g. manufacturers or other applicants) to submit an expression of interest (EOI) to WHO by a specified deadline for the purpose of participating in the WHO prequalification procedure in respect of the product(s) listed in the invitation. Such an EOI should be accompanied by the required documentation on the product(s) in question.