Glossary

Criteria established based on possible impact to product quality, outside the operating range (acceptance criteria). A documented response is usually required.(also see: Action Point)

Criteria established based on possible impact to product quality, outside the operating range (acceptance criteria). A documented response is usually required.(also see: Action Point)

Criteria established based on possible impact to product quality, outside the operating range (acceptance criteria). A documented response is usually required.

Used in determining when a parameter has drifted outside the operating range.

Used in determining when a parameter has drifted outside the operating range.

AIDS Clinical Trials Information Service

Material used to adsorb organic impurities from water. Derived from wood, lignite, pulp-mill char, blood, etc. The source material is initially charred at high temperature to convert it to carbon. The carbon is then “activated” by oxidation from exposure to high temperature steam. It comes in granular or powdered form.

The formation of an antibody that can be stimulated by infection or vaccination.

Any component that is 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 the body of man or other animals. The term includes those components that may undergo chemical change in the manufacture of the drug product and is present in the drug product in a modified form intended to furnish the specified activity or effect.

(ICH Q7) Any substance or mixture of substances intended to be used in the manufacture of a drug (medicinal) product and that, when used in the production of a drug, becomes an active ingredient of the drug product. Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure and function of the body.

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. API Starting Materials are normally of defined chemical properties and structure.

The region of a protein molecule that binds the specific substrate and chemically modifies it into the new product (in an enzyme) or interacts with it (in a receptor).

Heating systems that use solar energy to heat a fluid -- either liquid or air -- and then transfer the solar heat directly to the interior space or to a storage system for later use. (also see: Passive Solar)

The raw material that is identified as directly related to the active chemical comprising the product, and is defined at the first stage during chemical synthesis at which part or most of the critical moieties are present. Defining active starting material defines the step at which compliance with cGMP requirements begins during manufacturing. For biopharmaceuticals, this term is not used.

Energy-requiring transport of a solution across a membrane in the direction of increasing concentration.

In a clinical trial, treatment that is intended to reduce or eliminate the disease in a patient.

The quantity that is actually produced at any appropriate phase of manufacture, processing, or packaging of a particular drug product.

A peripheral (output) device which translates electrical signals into mechanical actions; e.g., a stepper motor which acts on an electrical signal received from a computer instructing it to turn its shaft a certain number of degrees or a certain number of rotations.

Administrative Conference of the United States

Describes a disorder as a one-time condition (an injury or infection), rather than as a chronic disease such as diabetes.

An adverse effect on the human body with symptoms of high severity turning quickly to a crisis. Acute effects are normally the result of short-term exposures.

A single exposure to a toxic substance that results in severe biological harm or death. Acute exposures are usually characterized as lasting up to 14 days.

The ability of a substance to cause poisonous effects resulting in severe biological harm or death soon after a single exposure or dose. Also, any severe poisonous effect resulting from a single short-term exposure to a toxic substance.

An organic radical having the general formula RCO, derived from the removal of a hydroxyl group from an organic acid.

Introduction of an acyl group to a molecule.