GLP
Good laboratory practices; according to 21 CFR Part 58, regulations to ensure quality of nonclinical laboratory studies related to safety. All activity
is recorded, trained staff uses only established procedures, and records and samples are maintained.
Glu
Glutamic acid; one of over 20 naturally occurring amino acids.
Gly
Glycine; one of over 20 naturally occurring amino acids.
glycoproteins Proteins that contain sugar side chains added as a posttranslational process; presence of sugar side chains often affects
activity and in vivo stability.
glycosylation Adding one or more carbohydrate molecules onto a protein (a glycoprotein) after it has been built by the ribosome; a posttranslational modification.
GMPs
Good manufacturing practices; according to 21 CFR Parts 210, 211, 600, 610, and (for devices) 820, current good manufacturing practices (cGMPs) influence
the manner in which biopharmaceuticals and other drugs and medical devices are produced. Standard operating procedures must
be followed, processes must be validated, equipment must be qualified, and properly trained staff must maintain a clean/sterile
environment.
Golgi body A cell organelle consisting of stacked membranes where posttranslational modifications of proteins are performed; also called
Golgi apparatus.
GMPs and guidance documents cover all aspects of the business that can affect product quality, from the handling of raw materials
(above) through the final product.
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Gram's stain/Gram's method A method developed by Hans C.J. Gram for identifying bacteria. Bacteria are stained with gentian violet, then treated with
Gram's solution (water, potassium iodide, and water) and counterstained. They are then treated with alcohol and washed with
water. Gram-negative bacteria do not retain the purple dye (E. coli, for example); Gram-positive bacteria do retain the purple dye (Staphylococcus aureus, for example).
GRAS
Generally recognized as safe; a special status afforded by FDA to ingredients and methods that have a proven, longstanding history of causing no harm to
humans or animals.
growth hormone A protein produced in the pituitary gland to control cell growth.
Guidance for Industry
The next regulatory level up from a Points to Consider (PTC) document (and below official Code of Federal Regulations law).
GXP All-inclusive term for GCPs, GLPs, and GMPs.
H
HACCP
Hazard analysis and critical control points analysis; A method used to perform risk assessment and risk mitigation. Each unit operation is evaluated to define what critical parameters
must be kept within specified ranges, and the process control strategy is designed to monitor and control within that range.
Used in the food industry with much success. (See also FMEA)
half-life The time it takes for 50% of a drug or drug formulation given to a patient to be eliminated or destroyed by natural processes.
haptens A small, separable part of an antigen that reacts specifically with an antibody but is incapable of stimulating antibody production
except in combination with a carrier protein molecule.
harm Physical injury or damage to the health of people, or damage to property or the environment [from ISO 14971; see also ICH
Q9].
hazard The potential source of harm [From ICH Q9; see also ISO/IEC Guide 51].
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