term1 Definition1term2 Definition2term3 Definition3
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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 particulardrug product based on the initial input.
Actual Yield
An enclosed space with two or more doors, which is interposed between two ormore rooms e.g. of different standard of cleanliness for the purpose ofcontrolling the air flow between those rooms when they need to be entered. Anairlock may be designed for and used by either people or materials; in the lattercase it can be termed a “pass through hatch”. An airlock 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 bythe trade and accredited by the manufacturer based on a vendor rating whichinclude but not limited to conformance to the company or compendium materialspecifications.
Approved Supplier
A quantity of drug product/device that is homogenous in character and qualityproduced during a given cycle of manufacture and from a specificmanufacturing order.
Batch
A designation in numbers or letters or combination thereof that identifies thebatch, and permits the tracing of the complete history of a batch, including allstages of its production, control and distribution.
Batch Number or Lot Number
Including genetically engineered microorganisms, cell cultures, as well as endoparasites, whether pathogenic or not.
Microbiological Agents
Any processed material which has to undergo another process includingpackaging operation to become a finished product.
Bulk Product
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