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level: Level 1 of Definition of TERMS

Questions and Answers List

level questions: Level 1 of Definition of TERMS

Question	Answer
Instrument, apparatus, or contrivances, including their components, parts and accessories, intended (1) for use in the diagnosis, cure, mitigation, or prevention of disease in man and animals; or (2) to affect the structure or any function of the body of man or animal.	Device
A date fixed for each individual batch on or before which the batch is expected to meet the standard specifications for quality, safety and efficacy.	Expiration Date
For Blood Products: Any area used for the collection, processing, compatibility testing, storage or distribution of blood and blood components. For Other Products (drugs, medical devices, bulk chemical material and others): This refers to the building, premises and equipment necessary in the manufacture of drugs.	Facilities
A product which has UNDERGONE ALL STAGES of manufacturing operations.	Finished Product
It is the SYSTEM of quality assurance aimed at ensuring that products are CONSISTENTLY MANUFACTURED to a quality appropriate for their intended use. It is thus concerned with both manufacturing and quality control processes and procedures.	Good Manufacturing Practice (GMP)
Contaminated with extraneous biological agents and therefore capable of spreading infection.	Infected ( Man or Animal)
CHECKS AND TESTS instituted and carried out IN THE COURSE OF THE MANUFACTURE of a drug to assure identity, strength, quality and purity.	In-Process Control
Any processed substance or mixture of substances which has to UNDERGO ONE OR MORE FURTHER STAGES OF PROCESSING to become finished product.	Intermediate Product
The process in which blood is extracted from the donor, a LEUKOCYTE CONCENTRATE IS SEPARATED, and the remaining formed elements and residual plasma are returned to the donor.	Leukopheresis
Gases that, at the specified temperature and pressure, REMAIN AS A LIQUID IN THE CYLINDER.	Liquefied Gases
A BATCH or any portion of batch PRODUCED BY A CONTINUOUS PROCESS, an amount of drugs produced in a unit of time or quantity in a manner that assures its UNIFORMITY and in either case which is identified by a distinctive lot number and has uniform character and quality within specified limits.	Lot
See batch number	Lot Number
Equipment or apparatus designed to enable one or more GAS CONTAINERS to be FILLED SIMULTANEOUSLY from the same source.	Manifold
The COMPLETE SET OF ACTIVITIES TO PRODUCE A DRUG that comprise production and quality control from dispensing of materials to the release for distribution of the finished product.	Manufacture or Manufacturing