Pharmaceutical Drug Manufacturers

IBC (Intermediate Bulk Container)
A container for storing, transporting, and handling dry materials. Normally bigger than ½ cubic meter but smaller than 3 cubic meters, dust free, able to receive and discharge a variety of materials, and capable of automation.

IDLH (Immediately Dangerous to Life and Health)
A concentration of airborne contaminants, normally expressed in parts per million (ppm) or milligrams per cubic meter, which represents the maximum level from which one could escape within 30 minutes without any escape-impairing symptoms or irreversible health effects. This level is established by the National Institute of Occupational Safety and Health (NIOSH).

Immune Response
The production of antibodies (humoral response) or particular types of cytotoxic lymphoid cells (cell-mediated response) on challenge with an antigen.

Immuno Electrophoresis
The separation of different antigen-antibody systems by diffusion in an agar gel; a separate precipitation band in the gel detects each system.

Immunity
The state of an organism in which protection from many infectious diseases is afforded by prior exposure to the infectious agents.

Immunogen
A substance that is capable of causing antibody formation.

Immunoglobulin (Ig)
A member of a class of proteins that functions as an antibody. The wide range of different specifities of antibodies depends on subtle differences in their structure.

Immunoglobulin A (IgA)
The body's first line of defense against infectious diseases and is present in seromucous secretions such as saliva, tears, nasal fluids, sweat and secretions of the lung and genito-urinary and gastro-intestinal tracts.

Immunoglobulin (IgA, IgD, IgE, IgG, and IgM)
A class of serum proteins rich in antibodies. Often used, along with the more specific monoclonal antibodies, in diagnostic reagents in the health field.

Immunology
The study of how the body defends itself against disease.

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

Imprinting
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.

Impurity
Any component present in the intermediate or API (Active Pharmaceutical Ingredient) that is not the desired entity. It may be either process or product related.

Impurity Profile
A description of the identified and unidentified impurities present in a typical batch of API (Active Pharmaceutical Ingredient) produced by a specific controlled production process. It includes the identity or some qualitative analytical designation (e.g. retention time), the range of each impurity observed, and type of each identified impurity. For each API there should be an impurity profile describing the identified and unidentified impurities present in a typical batch. The impurity profile is normally dependent upon the process or origin of the API.

Inactive Ingredient
Any component other than an active ingredient.

Inactivation
Any process that destroys the ability of a specific microbiological agent or eukaryotic cell to self-replicate.

Incidental Release
The discharge of a microbilogical agent or eukaryotic cell from a containment system that is expected when the system is appropriately designed and properly operated and maintained. Incidental releases are de minimis in nature.

Inclusion Body
Condensed particles of protein formed inside E. coli and other bacteria formed when the cells are forced to make large amounts of a product protein. The cells must be broken to harvest inclusion bodies.

Inclusions
Particles of foreign material in a metallic matrix. The particles are usually compounds such as oxides, sulfides, or silicates, but may be any substance foreign to and essentially insoluble in the matrix.

IND (Investigational New Drug) Application
A document filed with the FDA prior to clinical trial of a new drug. It gives a full description of the new drug, where and how is manufactured, all QC information, etc. The IND is followed by NDA (New Drug Application).

Indirect Impact System
An engineering system considered having no direct impact on product quality.

Inert
Does not dissolve in water or react chemically with other substances.

Infarct
A necrotic area of tissue resulting from failure of local blood supply.

Infected
Contaminated with extraneous biological agents and therefore capable of spreading infection.

Infectious
Able to cause disease in a susceptible host.

Infectious Agent
A biological organism that can establish a process of infection.

Infiltration
The entry of air from an adjoining room or from outdoors through wall and ceiling openings due to a difference in air pressure between the two areas.

Informatics
The study of the application of computer and statistical techniques to the management of information. In genome projects, informatics includes the development of methods to search databases quickly, to analyze DNA sequence information, and to predict protein sequence and structure from DNA sequence data.

Infusion
The introduction of parenterals into a vein (intravenous).

Injection
A preparation intended for parenteral administration and/or constituting or diluting a parenteral article prior to administration. The introduction of parenterals may be into the subcutaneous cellular tissue (subcutaneous or hypodermic), or the muscular tissue (Intramuscular).

In-Line
An integral part of the flow path. In a fluid stream, something is said to be in-line if the entire fluid stream flows directly through or past it.

In-Process Control
Checks performed during production in order to monitor and if necessary to adjust the process and/or to ensure that the intermediate or API (Active Pharmaceutical Ingredient) conforms to its specification. (also called Process Control)

Innocuous
Safe, not contaminated.

Inoculum
1. Fermentation: an aliquot of a pure culture of microorganism added to the primary seed tank to initiate fermentation.