Glossary

Cosmetics Toxicology Branch (CFSAN)

Continuously Stirred Tank Reactors

Counseling and Testing Site

Correspondence Tracking System

Cellular and Tissue Therapy Branch (CBER)

Clinical Trials Exemption (United Kingdom)

Content Uniformity

A metric unit of volume, commonly used in expressing concentrations of a chemical in a volume of air. One cubic meter equals 35.3 cubic feet or 1.3 cubic yards. One cubic meter also equals 1000 liters or one million cubic centimeters.

Critical Utilities Community of Knowledge (ISPE term)

Confidential Unit Exclusion

Commissione Unica del Farmaco (Italy)

As a noun, cultivation of living organisms in prepared medium; as a verb, to grow in prepared medium.

Any nutrient system for the artificial cultivation of bacteria or other cells; usually a complex mixture of organic and inorganic materials.

Critical Use Point

The process of changing properties of polymer into a more stable and usable condition. This is accomplished by the use of heat, radiation, or reaction with chemical additives.

The time periods at defined conditions to which a reacting thermosetting material is processed to reach a desired property level.

(ANSI) A movable, visible mark used to indicate a position of interest on a display surface.

A device that:1.Necessarily deviates from devices generally available or from an applicable performance standard or premarket approval requirement in order to comply with the order of an individual physician.2.It is not generally available to, or generally used by, other physicians.3.It is not generally available in finished form for purchase or for dispensing upon prescription.4.It is not offered for commercial distribution through labeling or advertising.5.It is intended for use by an individual patient named in the order of a physician and is to be made in a specific form for that patient, or is intended to meet the special needs of the physician in the course of professional practice.

Process or facility owner who will use the project outcome to generate revenue for the business.

(ISO) Organization or person that receives a product.

Organization, or the agent thereof, responsible for specifying the requirements of a cleanroom or clean zone.

A recipient of a product provided by the supplier.

Process with four basc phases; Gaining Entry – making initial contact, Contracting – clarifying and agreing roles and responsibilities, Engagement – meeting agreed roles and responsibilities, and Disengagement – agreeing that the contract is complete.