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level: Level 2 of Definition of Terms

Questions and Answers List

level questions: Level 2 of Definition of Terms

Question	Answer
A CULTURE OF FULLY CHARACTERIZED CELLS filled into containers in a single operation, processed together and stored to ensure uniformity and stability. Normally stored at -70oC or lower.	Master Cell Bank
A CULTURE OF A MICROORGANISM distributed from a SINGLE BULK into containers in a single operation to ensure uniformity, stability and to prevent contamination.	Master Seed Lot
The PROCESS OF PACKING which is that part of the production cycle applied to a bulk product to obtain the finished product.	Packaging
Any MATERIAL used in the PACKAGING of a bulk product to obtain the finished product.	Packaging Material
The LIQUID PORTION OF BLOOD separated and used as material to prepare another product.	Plasma (for further manufacture)
The process in which BLOOD IS EXTRACTED FROM THE DONOR, the PLASMA is SEPARATED from the formed elements and at least the red blood cells are returned to the donor.	Plasmapheresis
The process in which blood is extracted from the donor, the PLATELET CONCENTRATE IS SEPARATED, and the remaining formed elements and residual plasma are returned to the donor.	Plateletpheresis
The DEGREE OF VARIATION between individual test results when the method is used separately to different samples drawn from the same batch of material. This will include variation between analysts, between days, between tests on the same prepared extract of a given sample, between different extracts and between laboratories conducting the same test. It is normally divided into two types: - Repeatability (within laboratory), and - Reproducibility (between laboratories).	Precision ( in analytical assay and method)
A system of CONTAINMENT that PREVENTS THE DISPERSAL of a biological agent INTO THE IMMEDIATE WORKING ENVIRONMENT. It involves the employment of closed containers or safety biological cabinets accompanied with secure operating procedures.	Primary Containment
DESCRIPTION OF THE OPERATIONS to be executed, the precautions to be implemented directly or indirectly related to the manufacture of a drug.	Procedures
The PART OF PRODUCTION CYCLE starting from WEIGHING OF RAW MATERIALS to FINISHED PRODUCT.	Processing
Any PROCESS EMPLOYED AFTER COLLECTION and before computability testing of BLOOD. It includes the identification of a unit of donor blood, the preparation of components from such unit of donor blood, serological testing, labeling and associated record keeping.	Processing of Blood
ALL OPERATIONS STARTING from DISPENSING OF MATERIALS to PROCESSING, packaging, to finished product.	Production