Glossary

(ICH Q5C) Any component of the drug substance (bulk material) or drug product (final container product) which is not the chemical entity defined as the drug substance, an excipient, or other additives to the drug product.

(ICH Q3B (R2)) Any component of the new drug product that is not the drug substance or an excipient in the drug product.

(ICH Q7) Any component present in the intermediate or API that is not the desired entity.

(ICH Q3A (R2)) A description of the identified and unidentified impurities present in a new drug substance.

The acceptable levels of impurities in the final drug substance.

(ICH Q3B (R2)) A description of the identified and unidentified impurities present in a drug product.

(ICH Q7) A description of the identified and unidentified impurities present in an API.

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.

Ion Mobility Spectrometry

Room condition in which processing is being performed with operators present.

Studies done “in the computer”. Modeling a protein in silico refers to providing an integrated, computerized view of the molecule.

Meaning in the natural place or in the original place.1. Experimental treatments performed on cells or tissue rather than on extracts from them.2. Assays or manipulations performed with intact tissues.

The base pairing of a sequence of DNA to metaphase chromosomes on a microscope slide.

Non-clinical testing conducted in an artificial environment such as a test tube or culture medium.

Literally means “in glass”. In isolation from the living organism in an experimental, artificial environment (e.g. cells in tissue culture); performed in the laboratory rather than in a living organism (in vivo).

(ICH Q5B/5QD) Measure of time between thaw of the MCB vial(s) to harvest of the production vessel measured by elapsed chronological time in culture, by population doubling level of the cells, or by passage level of the cells when subcultivated by a defined procedure for dilution of the culture.

(ICH Q5A (R1)) A measure of the period between thawing of the MCB vial(s) and harvest of the production vessel measured by elapsed chronological time in culture, population doubling level of the cells or passage level of the cells when subcultivated by a defined procedure for dilution of the culture.

Occurring within a living system, plant, or animal.

Testing conducted in living animal and human systems.

(ICH Q6B) An appropriately characterized material prepared by the manufacturer from a representative lot(s) for the purpose of biological assay and physicochemical testing of subsequent lots, and against which in-house working reference material is calibrated.

(ICH Q6B) A material prepared similarly to the primary reference material that is established solely to assess and control subsequent lots for the individual attribute in question. It is always calibrated against the in-house primary reference material.

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. (also see: On-Line, Off-Line)

Checks performed during production in order to monitor and, if appropriate, to adjust the process and/or to ensure that the intermediate or API conforms to its specifications.(also see: Process Control)

(ICH Q7) Checks performed during production in order to monitor and, if appropriate, to adjust the process and/or to ensure that the intermediate or API conforms to its specifications.