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level: Definition of Terms 2

Questions and Answers List

level questions: Definition of Terms 2

Question	Answer
An area constructed, operated and equipped with air-handling and filtration system in order to prevent contamination of the external environment by biological agents from within the area.	Contained Area
Anything that cause contamination to the product.	Contaminants
An area constructed and operated to control the introduction of potential contamination (an air supply approximately class III may be appropriate), and the consequences of accidental release of living organisms. The level of control exercise shall reflect the nature of the organism employed in the process. The area shall be maintained at a pressure negative to the immediate external environment and allow for the efficient removal of small quantities of airborne contaminants.	Controlled Area
Contaminations of a starting, intermediate product or finished product.	Cross Contamination
A container designed to store liquefied gas at extremely low temperature.	Cryogenic Vessel
A container designed to store gas at a high pressure.	Cylinder
The date indicating the start of processing of every batch.	Date of Manufacture
The activity of weighing, counting or measuring and checking of starting materials and issuing these to the appropriate production personnel; details of the activity being duly and properly documented.	Dispensing
Written recording of all procedures, instructions and processes involved in the manufacture of drug products.	Documentation
Any substance or mixture of substances in finished dosage forms that is manufactured, offered for sale, or presented for use in (1) the treatment, mitigation, cure, prevention, or diagnosis of disease, abnormal physical state, or the symptoms thereof in man or animal; or (2) the restoration, correction or modification of organic functions in man or animal; regardless of whether it is in package form.	Drug Product