Glossary

Any chemical compound that may be used on or administered to humans as an aid in the diagnosis, treatment, cure, mitigation, or prevention of disease or other abnormal conditions.See also: API

(ICH Q7) The dosage form in the final immediate packaging intended for marketing. (Reference Q1A)

Name given to a molecule discovered in R&D that elicits a desired biologic response. After their discovery in R&D, drug candidates move down the drug discovery pipeline and are tested for ADMET properties and their ability to produce a desired biologic response in animal and human subjects.

Method by which a therapeutic agent is delivered to its site of action. For traditional therapeutic agents this is another name for formulation. However, biotechnology has allowed the development of a range of new therapeutic-agent delivery systems, such as liposomes and other encapsulation techniques, and a range of mechanisms that target a therapeutic agent to a particular cell or tissue.

Detailed information concerning a specific facility, process or product submitted to the drug regulatory authority, intended for incorporation into the application for marketing authorization.

Required documentation for material accountability, quantity used and left over, and date of disposal.

A finished dosage form, for example, tablet, capsule, solution, etc. that contains one or more APIs (Active Pharmaceutical Ingredients) generally, but not necessarily, in association with inactive ingredients. The term also includes a finished dosage form, which does not contain an API but it is intended to be used as a placebo.

A medicinal product supplied as a finished dosage form. For example, a tablet, a capsule, or a solution, that contains an active drug ingredient generally, but not necessarily, in association with inactive ingredients. This could be an IMP or NIMP. The term also includes a finished dosage form that does not contain an active ingredient, but is intended to be used as a placebo.

A finished dosage form, for example, tablet, capsule, solution, etc., that contains one or more APIs (Active Pharmaceutical Ingredients) generally, but not necessarily, in association with inactive ingredients. The term also includes a finished dosage form, which does not contain an API but it is intended to be used as a placebo.

(ICH Q1A (R2)) The dosage form in the final immediate packaging intended for marketing.

(ICH Q6B) A pharmaceutical product type that contains a drug substance, generally, in association with excipients.

FDA provides information on drug products that have been recalled due to manufacturing problems and/or safety concerns. In addition to information released to the public by a manufacturer using the normal media channels, FDA posts information about these recalled drug products at www.fda.gov/opacom/7alerts.html

A drug recall is an action taken by a firm to remove a product from the market that FDA considers to be in violation of the law. Recalls are classified as Class I, Class II, or Class III. Class I recalls are the most serious and involve situations where there is a reasonable probability that the use of or exposure to a violative product, will cause serious adverse health consequences or death. A drug may be recalled due to factors such as problems with packaging, manufacturing, or contamination.

(ICH Q7)

Any component intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of a disease, or to affect the structure or any function of the human body, but does not include intermediates used in the synthesis of such ingredient. The term includes those components that may undergo chemical change in the manufacture of the drug product, and are present in the drug product in a modified form intended to furnish the specified activity or effect.

Any component intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of humans. The term includes those components that may undergo chemical change in the manufacture of the drug product, and be present in the drug product in a modified form intended to furnish the specified activity or effect. A drug substance is an API.

(ICH Q1A (R2)) The unformulated drug substance that may subsequently be formulated with excipients to produce the dosage form.

(ICH Q6B) The material which is subsequently formulated with excipients to produce the drug product. It can be composed of the desired product, product-related substances, and product- and process-related impurities. It may also contain excipients including other components such as buffers.

In rare cases, FDA may need to reassess and change its approval decision on a drug. A conclusion that a drug should no longer be marketed is based on the nature and frequency of the adverse events and how the drug’s benefit and risk balance compares with treatment alternatives. When FDA believes that a drug’s benefit no longer outweigh its risks, the agency will ask the manufacturer to withdraw the drug.

Air from which all water vapor and contaminants have been removed. Its composition by volume is:1.Nitrogen78.08%2.Oxygen20.95%3.Argon 0.93%4.Carbon Dioxide 0.035.Other gases 0.00003(also see: Moist Air)

Sterilization utilizing a heating oven or continuous tunnel (gas or electric heated) as opposed to steam sterilization in an autoclave usually used for glassware and metal parts. In depyrogenation temperatures of 250ºC (482ºF) result in sterilization and the inactivation of endotoxin present on the surface of the equipment.

The term dry place denotes a place that does not exceed 40% average relative humidity at Controlled Room Temperature or the equivalentwater vapor pressure at other temperatures.