Glossary

The net storage capacity is the space where it is suitable (both thermally and ergonomically) to store vaccines with any components necessary to operate within the acceptable temperature range fully prepared and in place. If a legal manufacturer would declare more than one vaccine storage capacity for the same internal and external dimensions, they must prequalify with different branding, one model for each different storage volume. The capacity will be published as volume in litres.

Actives that have not previously been authorized for marketing as a drug for use in humans in the country in question.

Nonconformity refers to a failure to comply with requirements. A requirement is a need, expectation or obligation. It can be stated or implied by an organization, its customers or other interested parties. There are many types of requirements. These include quality requirements, customer requirements, management requirements, product requirements, process requirements and legal requirements. Whenever an organization fails to meet one of these requirements, a nonconformity occurs.

Storage in dry, well-ventilated premises at temperature of 15–25 °C or,depending on climatic conditions, up to 30 °C. Extraneous odours, other indications of contamination, and intense light have to be excluded.