Glossary: C
CFM
Change Area
Often a change room operates at a lower classification and pressure than the main…
CIP
Clean in Place products and processes – Clean-in-place is a method of cleaning the…
Clean Area
An area with defined particle and microbiological cleanliness standards. Source: GMP Draft Annex 1
Clean Non Classified (CNC) area
The level, type and frequency of both the cleaning program and the environmental monitoring…
Cleaning
The removal of soils and residues (including biofilms) through use of a detergent. This…
Cleanroom
A cleanroom is a “room within which the number concentration of airborne particles is…
Cleanroom extension
A cleanroom may need to be extended to allow organisations to react to increased…
Cleanroom relocation
There are a number of reasons for which a cleanroom may need to be…
Closed system
A system in which the sterile product is not exposed to the surrounding environment.…
CMC Pharmaceuticals
CMC is an acronym for Chemistry Manufacturing and Controls, which are stages of the…
Colony Forming Unit (cfu)
A microbiological term that describes the formation of a single macroscopic colony after the…
Commissioning
Activities to verify that equipment and systems are installed according to specification Source: GMP…
Component
Any ingredient intended for use in the manufacture of a drug product, including those…
Composite
A material made up of 2 or more component parts to create a material…
Coved floor
When the floor is extended at the edges to be applied up the wall,…
Critical Area
An area designed to maintain sterility of sterile materials. Sterilized product, containers, closures, and…
Critical surfaces
Surfaces that may come into contact with, or directly affect, a sterilized product or…