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level: Definition of Terms

Questions and Answers List

level questions: Definition of Terms

Question	Answer
The nearest value obtained during measurement or analysis to the true value.	Accuracy
The quantity that is actually produced at any phase of production of a particular drug product based on the initial input.	Actual Yield
An enclosed space with two or more doors, which is interposed between two or more rooms e.g. of different standard of cleanliness for the purpose of controlling the air flow between those rooms when they need to be entered. It may be designed for and used by either people or materials; in the latter case it can be termed a “pass through hatch”. It can also be the “anteroom” to a clean room in which sterile goods are handled.	Airlock
A supplier of all components of finished products generally approved for use by the trade and accredited by the manufacturer based on a vendor rating which include but not limited to conformance to the company or compendium material specifications.	Approved Supplier
A quantity of drug product/device that is homogenous in character and quality produced during a given cycle of manufacture and from a specific manufacturing order.	Batch
A designation in numbers or letters or combination thereof that identifies the batch, and permits the tracing of the complete history of a batch, including all stages of its production, control and distribution.	Batch Number
A contained system, such as a fermenter, into which biological agents are introduced together with other materials in order to effect their multiplication or their production of other substances by reaction with other materials. Are generally equipped with devices for regulation, control connection, material addition and material withdrawal.	Biogenerator
include genetically engineered microorganisms, cell cultures, as well as endoparasites, whether pathogenic or not.	Microbiological Agents
Whole blood collected from a single donor and processed either for transfusion or further manufacturing.	Blood
Any processed material which has to undergo another process including packaging operation to become a finished product.	Bulk Product
The operations carried out to determine the accuracy of measuring instruments, of “material measures” such as masses or gauges and of measurement standards.	Calibration
Is validated for a passage level or number of population doubling beyond that which was achieved during routine production. A system whereby successive batches of a product manufactured by culture in cells derived from the same master cell bank.	Cell Bank System
The in-vitro growing of cells isolated from multicellular organisms.	Cell Culture
An area with defined environmental control of particulate and microbial contamination, constructed and used in such a way as to minimize the introduction, generation and retention of contaminants within the area.	Clean Area
The in-vitro serological tests performed on donor and recipient blood samples to establish the serological matching of a donor’s blood or blood components with that of a potential recipient.	Compatibility Testing
Any material intended to be used for the manufacture of a product whether raw or packaging materials.	Component