Glossary

The study of how the body defends itself against disease.

A diverse class of proteins that boost the immune system. Many are cell factors that accelerate the production of specific cells that are important in mounting an immune response in the body. These proteins are being investigated for use in possible cures for cancer.

All the proteins concerned with the immune system (antibodies, interferon, and cytokines).

The concept of using the immune system to treat disease, for example, developing a vaccine against cancer. Immunotherapy may also refer to the therapy of diseases caused by the immune system, allergies for example.

Protein drugs consisting of an antibody joined to a toxin molecule. Immunotoxins can be made by linking toxin and antibody molecules chemically, or by fusing the genes for the toxin and the antibody. The antibody portion of the molecule facilitates binding to a target molecule or cell, and the toxin inactivates or kills the target molecule or cell.

Investigational Medicinal Product

Measure of the possible consequences of loss or corruption of a system. GAMP Philosophy is to establish the impact for different types of systems as one of High Impact, Medium Impact, or Low Impact.

A measure of the possible consequences of loss or corruption of a system.

Integrated Material Profile and Costing Tool

A change that is made to a system, which requires that a reassessment be performed to determine if the system type has changed, e.g., an indirect impact system that becomes a direct impact system after a change is made to the system or to another system.

The process of evaluating the impact of the operating, controlling, alarming and failure conditions of a system on the quality of a product.

Device designed to sample particles in the air, or other gas, through a collision with a solid surface.

Investigational Medicinal Product Dossier

(ICH Q1A (R2)) Containers that provide a permanent barrier to the passage of gases or solvents, e.g., sealed aluminum tubes for semi-solids, sealed glass ampoules for solutions.

Device designed to sample particles in air, or other gas, through a collision with a liquid surface and the subsequent entering into the liquid.

A device that is placed into a surgically or naturally formed cavity of the human body if it is intended to remain there for a period of 30 days or more. FDA may, in order to protect public health, determine that devices placed in subjects for shorter periods are also “implants” for purposes of this part.

The process of translating a design into hardware components, software components, or both.

(IEEE) The period of time in the software lifecycle during which a software product is created from design documentation and debugged.

(IEEE) A requirement that specifies or constrains the coding or construction of a system or system component.

A biochemical phenomenon that determines, for certain genes, which one of the pair of alleles, the mother’s or the father’s, will be active in that individual.

(ICH Q3A (R2)) Any component of the new drug substance that is not the chemical entity defined as the new drug substance.

Any entity of the drug substance (API) or drug product (final container product) that is not the chemical entity defined as the drug substance, an excipient, or other additives to the drug product.

Any component present in the intermediate or API that is not the desired entity. It may be either process or product related.

A foreign agent or material either introduced as part of processing (such as buffers or salts added during chromatography) or intrinsic to the nature of bioprocessing (such as product variants and cellular debris).

(ICH Q6A) Any component of the new drug substance which is not the chemical entity defined as the new drug substance. (2) Any component of the drug product which is not the chemical entity defined as the drug substance or an excipient in the drug product.