Glossary for the most common terms from the WHO guidelines

Criteria, expressed by numerical limits, ranges or other suitable measures, which should be met to release the drug substance or drug product or materials at different stages of their manufacture.

A substance used in the FPP, intended to furnish pharmacological activity or to otherwise have direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease, or to have direct effect in restoring, correcting or modifying physiological functions in human beings.

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 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.

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.