Gemba Walk
A method of walking through and personally observing processes. (TR84)
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Gels
Gels (sometimes called jellies) are semisolid systems consisting either of suspensions of small inorganic particles or of organic molecules interpenetrated by a liquid. Gels can be classed either as single-phase or two-phase systems. (TR79)
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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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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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Generator Set (Genset)
A generator unit that is used to provide electrical power to maintain the temperature in a container/ trailer in transit and is not attached to a stationary power source. Gensets consist of a diesel or electrically powered engine that produces the required voltage to operate the temperature control unit (TCU; reefer) on the container/trailer. (TR64)
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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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Gamma Irradiation
The process by which a material is rendered sterile by exposing the material to a radioactive source, such as Cobalt 60. (TR70) Ionizing radiation that can be used to sterilize a material. (TR26)
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Gauge Pressure
The pressure measured by a pressure gauge. Typically expressed in units of psig, bar or kilopascal. (TR45) Gauge pressure is the difference between a given fluid pressure and that of the atmosphere. (TR26)
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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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Genome Copy (GC)
An amount of nucleic acid equivalent to the genetic complement present in the genome of a single microorganism. (TR50)
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Germicide
A compound that destroys all vegetative microorganisms. (TR70)
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Genotypic
Relating to those characters that reside in the genetic complement of a specific strain of a specific organism. (TR51)
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Glide Force
Force in Newtons (N) required for plunger movement within an empty syringe. (TR73)
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Genetic Marker
A gene or DNA sequence within a chromosome which can be used for discrimination of one mycoplasma species or strain from another. (TR50)
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GMPs
Best practices in manufacturing of pharmaceuticals or biopharmaceuticals. From a regulatory standpoint, GMPs are regarded as the minimum current good manufacturing practice for methods to be used in, and the facilities or controls to be used for, the manufacture, processing, packaging, or holding of a drug to assure that such drug meets requirements of safety, identity and strength and meets the quality and purity characteristics that it purports or is represented to possess. (TR41) (TR 79)
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Good Distribution Practices (GDPs)
Defined as that part of quality assurance that ensures that the quality of the pharmaceutical product is maintained by means of adequate control of numerous activities which occur during the distribution process. (TR55)
(commonly abbreviated GDP, or as GDocP to distinguish from “Good Distribution Practice”) Describes standards by which documents are created and maintained. (TR56)
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Gram Positive
An organism that retains the Gram stain. (TR51)
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Good Engineering Practice (GEP)
Documented proven and accepted engineering methods and practices that applied throughout the project life-cycle to deliver solutions that are cost effective, are compliant with regulations and meet the requirements of the user. (TR48)
Those established engineering methods and standards that are applied throughout the lifecycle to deliver appropriate and cost-effective solutions. (TR60) (TR54-5)
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