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level: Level 4 Definition of terms

Questions and Answers List

level questions: Level 4 Definition of terms

Question	Answer
a SYSTEM OF CONTAINMENT that prevents the dispersal of a biological agent into the external environment or into other working areas. It involves the use of rooms with specially designed air handling, the existence of air locks and/or sterilizers for the exit of material. It may ADD TO THE EFFECTIVENESS OF PRIMARY CONTAINMENT (see Primary Containment).	Secondary Containment
is a SYSTEM where successive batches of product are DERIVED from the same MASTER SEED LOT at a given passage level.	Seed Lot System
A DESCRIPTION of starting material, intermediate, bulk or finished product IN TERMS OF ITS CHEMICAL, PHYSICAL AND MICROBIOLOGICAL CHARACTERISTICS, IF ANY. shall include descriptive and or numerical clauses stating standards and tolerated deviations, whenever applicable.	Specification of Material
RAW MATERIALS used in the production of a finished product (drugs).	Starting Materials
A ROOM or AREA of DEFINED ENVIRONMENTAL CONDITION with CONTROLLED PARTICULATE AND MICROBIAL CONTAMINATION, constructed, equipped and used to ELIMINATE the introduction, generation or retention of CONTAMINANTS.	Sterile Room / Sterile Area
INACTIVATION or reduction to an acceptable level OF ALL VIABLE MICROORGANISMS by a suitable process.	Sterilization
The QUANTITY that is EXPECTED OR PLANNED to be OBTAINED at any phase of production of a particular product, based on the quantity of components to be used.	Theoretical Yield
The VOLUME OF BLOOD or one of its components in a suitable volume of anticoagulant obtained from a SINGLE COLLECTION of blood.	Unit (of Blood)
The PROCESS OF CONFIRMING by recognized appropriate means or manner, that any material, process, procedure, activity, system, equipment or mechanics used in production and control consistently achieved the desired results.	Validation
A culture of cell DERIVED FROM THE MASTER CELL BANK and intended for use in the preparation of production of cell cultures and normally stored at - 70OC or lower.	Working Cell Bank
A culture of microorganism DERIVED from the MASTER SEED LOT and intended for use in PRODUCTION.	Working Seed Lot
A condition or SET OF CONDITIONS encompassing upper and lower processing limits and circumstances, within standard operating procedures, which pose the greatest CHANCE of product or PROCESS FAILURE when, compared to ideal conditions. Such conditions do not necessarily induce product or process failure.	Worst Case