Glossary

Any material fabricated, compounded, blended, or derived by chemical reaction that is produced for, and used in, the preparation of the drug product.

(ICH Q6A) Tests which may be performed during the manufacture of either the drug substance or drug product, rather than as part of the formal battery of tests which are conducted prior to release.

A virus, bacterium or other organism that has been treated to prevent it from causing a disease.

(ICH Q5A (R1)) Reduction of virus infectivity caused by chemical or physical modification

Elimination of the target material’s biological or chemical activity through chemicals, heat, or other means without necessarily eliminating the activity of other (non-targeted) material.

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

Any component other than an active ingredient.

Refers to a person's mental status and means inability to understand information presented, to appreciate the consequences of acting (or not acting) on that information, and to make a choice.

International Narcotics Control Board (UN)

Operational event which is not part of standard operation.

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.

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.

Discrete structures (virions, viral components, cellular material, aggregated proteins) present either normally or abnormally within cells.

The factors used to judge a participant’s eligibility for inclusion in a trial. There is an underlying rationale for the criteria selected. The rationale relates to the questions that the researchers are trying to answer by conducting the trial.

Particles of foreign material in a metallic or polymer matrix.

A term used to describe materials that could cause dangerous reactions from direct contact with one another.

Technically, a legal term meaning inability to manage one's own affairs. Often used as a synonym for incapacity.

A weld discontinuity in which fusion did not occur between weld metal and faces or between adjoining weld beads. Also, in welding of tubing, when the weld fully penetrates the wall thickness but misses the joint, leaving some portion of the inner (inside diameter) weld joint with unfused edges.

A groove weld in which the weld metal does not extend completely through the joint thickness.

An incompressible fluid is one whose density is constant everywhere. All fluid behave incompressibly (to within 5%) when their maximum velocities are below Mach 0.3 (326.24 ft/sec).

An incremental backup will only backup files that have been changed since the last backup of any type. This provides the quickest means of backup since it only makes copies of files that have not yet been backed up. The downside to this is that in order to perform a full restore, it is necessary to restore the last full backup first, followed by each of the subsequent incremental backups to the present day in the correct order. Should any one of these backup copies be damaged (particularly the full backup), the restore will be incomplete.

(IEEE) A software development technique in which requirements definition, design, implementation, and testing occur in an overlapping, iterative [rather than sequential] manner, resulting in incremental completion of the overall software product.

An apparatus in which environmental conditions (light, photoperiod, temperature, humidity, etc.) are fully controlled, and used for hatching eggs, multiplying micro-organisms, culturing plants, etc. cf culture room; growth cabinet.