Glossary Terms (Simple List)
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Gram Positive
An organism that retains the Gram stain. (TR51)
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Gravity Displacement
A sterilization process based on the principle that cold air within the chamber is heavier than the steam entering and will sink to the bottom of the chamber. As steam enters the chamber, air is pushed out the bottom drain and exits, with the condensate, through a steam trap. (TR01) (TR48) (TR61)
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Grid Profiling
A process of dividing areas of equivalent classifications into grids for the purpose of uniformly assessing contamination characteristics in that area.This process is usually confined to the validation of new facilities and not routine monitoring. (TR13)
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Grouping Strategy
A strategy for establishing similar cleaning processes, usually based on similar products or similar equipment, and to validate the cleaning process based primarily on validation data for a representative of the group. (TR29) (TR49)
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Growth Promotion Test
Test performed to demonstrate that media will support microbial growth. (TR22) (TR28)
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GXP (WHO)
Acronym for the good practice guides governing the preclinical, clinical, manufacturing, testing, storage, distribution and postmarket activities for regulated pharmaceuticals, biologicals, and medical devices, such as good laboratory practices, good clinical practices, good manufacturing practices, good pharmacovigilance practices and good distribution practices.(TR80)
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Half-Cycle Qualification
A qualification method that uses fifty percent of the exposure time to demonstrate sterilization cycle efficacy. The physical and biological lethality values achieved in the half-cycle exposure time are doubled to project the lethality that will be achieved by the full cycle.(TR01)
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Harm
Damage to health, including damage occurring from loss of product quality or availability. (TR44) (TR54) (TR54-2) (TR54-4) (TR68)
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Harvest Testing
The screening of a biopharmaceutical bulk cell culture harvest for any adventitious contaminants, including mycoplasma, before further processing. (TR50)
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Hazard
The potential source of harm. (TR44) (TR54) (TR54-2) (TR58) (TR61)