Glossary

A person or organization contracted by the employer to maintain the installation, devices, and/or appliances.

A major deviation from good manufacturing practice has been observed by the WHO inspection group during inspection of a contract research organization, manufacturing site or quality control laboratory.

All operations of purchase of materials and products, production, quality control, release, storage and distribution of pharmaceutical products, and the related controls.

Manufacturer: any person or legal entity engaged in the manufacture of a product subject to marketing authorization (MA) or licensure. May also refer to any person or legal entity that is an applicant or a holder of a MA or product licence where the applicant assumes responsibility for compliance with the applicable product and establishment standards. See also marketing authorization.

Also referred to as product licence or registration certificate. A legal document issued by the competent medicines regulatory authority that authorizes the marketing or free distribution of a medical product in the respective country after evaluation of safety, efficacy and quality. In terms of quality it establishes inter alia the detailed composition and formulation of the medical product and the quality requirements for the product and its ingredients. It also includes details of the packaging, labelling, storage conditions, shelf life and approved conditions of use. May also be referred to as “product licence” or “licence” in this and other documents.

A formal application to the national regulatory authority for approval to market a new medicine. The purpose of the MA application is to determine whether the medicine meets the statutory standards for safety, effectiveness, product labelling information and manufacturing. Also referred to as “licence application” in other documents.

For the purposes of this website, the term marketing authorization holder refers to any person or entity that holds the legal responsibility for the product on the market by submission of the required documentation on a product that has been listed after evaluation as registered or approved. It also refers to a person or legal entity allowed to apply for a change to the MA or licence. Also referred to as the “manufacturer” or “applicant” in this and other documents.

A general term used to denote raw materials (starting materials, reagents, solvents), process aids, intermediates, active pharmaceutical ingredients and packaging and labelling materials.

The mass of an appliance when fully loaded with vaccines at a density of 0.8 kg per litre of vaccine net storage capacity and with any components necessary to operate within the acceptable temperature range fully prepared and in place.

The weight of a container when fully loaded with coolant-packs and vaccines with a density of 0.8 kg per litre of vaccine storage capacity.

A type of photovoltaic (PV) to battery charge control that optimizes solar array output by operating as a direct current (DC)-to-DC converter. It uses the DC input from the PV array and converts it back to a different DC voltage and current so that the PV module is correctly matched to the battery. This allows a solar array to be wired at optimal voltage to overcome long cable distances that otherwise would result in excessive voltage drop or unacceptably large cable diameter. 

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. On ths website, the terms medicine and pharmaceutical product (see below) are used interchangeably.

A national body that administers the full spectrum of medicine regulatory activities, including at least all of the following functions in conformity with national medicine legislation:

marketing authorization of new products and variations of existing products

quality control laboratory testing

monitoring of adverse drug reactions

provision of information on medicines and promotion of rational use of medicines

good manufacturing practice inspections and licensing of manufacturers, wholesalers and distribution channels

enforcement operations

monitoring of drug use.

A transportable, powered appliance moveable by a single person or multiple people for short periods, intended primarily for longer-range transportation by a vehicle (e.g. truck, motorbike, camel). All appliances must be designated by the legal manufacturer as one of three appliance types: lightweight, medium-weight, or heavy-weight.

A branch of science that refers to microbes of all of types, including bacteria, viruses, rickettsia, protozoa, fungi and prions. Derived words (such as microbiological) have a similar meaning.

Cold life with a full coolant load at the minimum rated ambient temperature.

The lowest constant ambient temperature at which the vaccine storage compartment remains above 0°C. The test is carried out at +15°C unless the manufacturer specifies a lower figure.

The lowest constant ambient temperature at which the acceptable temperature range can be maintained with a full vaccine load. All models must be able to operate at a continuous minimum ambient temperature of +10.0°C or lower while maintaining the acceptable temperature range.

Moderate zone units must maintain an acceptable temperature range while operating at a steady +27°C ambient temperature and over a+27°C/+10°C day/night cycling temperature range.

The Montreal Protocol, finalized in 1987, is a global agreement to protect the stratospheric ozone layer by phasing out the production and consumption of ozone-depleting substances. 

Multisource pharmaceutical products are pharmaceutically equivalent products that may or may not be therapeutically equivalent. Multisource pharmaceutical products that are therapeutically equivalent are interchangeable.