G
GAMP

Good Automated Manufacturing Practices. Minimum requirements for the use of quality management system, methods, and facilities or controls to be used in the automated manufacture, processing, packing, or holding of a drug product and its ingredients.

Generally Recognized as Safe (GRAS)

GRAS is an acronym for the phrase Generally Recognized As Safe. Under sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act (the Act), any substance that is intentionally added to food is a food additive, that is subject to premarket review and approval by FDA, unless the substance is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use, or unless the use of the substance is otherwise excluded from the definition of a food additive. [6]

Genetically Modified Organism (GMO)

An organism, with the exception of human beings, in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination. [6]

Genotoxic Carcinogens

Carcinogens which produce cancer by affecting genes or chromosomes. [16]

Genotoxic Impurities

Impurities present in the finished dosage form that may cause changes to the genome.

Genotoxicity, Genetic toxicity

A broad term that refers to any deleterious change in the genetic material regardless of the mechanism by which the change is induced. [7]

GEP

Good Engineering Practices

GMA

Grocery Manufacturers Association

GMA - SAFE

The GMA (Grocery Manufacturers Association) - SAFE assessment is a thorough description of a food production, handling or storage facility?s policies and practices, documented by a skilled auditing practitioner and communicated through a web based data ma

GMO

Genetically Modified Organism

GMP

Good Manufacturing Practices

good distribution practices (GDP)

Requirements for the quality system under which drug products and their ingredients are handled and distributed.

Good Distribution Practices (GDP)

The general principles of good practices in the pharmaceutical starting materials supply chain. [4], including requirements for purchase, receiving, storage and export. GDP regulates the movement of products from the premises of the manufacturer to the end user, or to an intermediate point by means of various transport methods.

Good Documentation Practices

Common documentation expectations for the proper completion of GMP documents. (SOP 20)

Good Engineering Practices (GEP)

Established engineering methods and standards that are applied throughout the project life-cycle to deliver appropriate, cost-effective solutions. [23]

Good Manufacturing Practices (GMP)

Minimum requirements for the quality management system methods, and facilities or controls to be used for the manufacture, processing, packing, or holding of a drug product and its ingredients.

Good Storage Practices (GSP)

Good storage practices are that part of quality assurance that ensures that the quality of pharmaceutical products is maintained by means of adequate control throughout the storage thereof. [17]

Good Trade and Distribution Practices (GTDP)

Good trade and distribution practices are that part of quality assurance that ensures that the quality of pharmaceutical products is maintained by means of adequate control throughout the numerous activities which occur during the trade and the distribution process. [17]

Grade

A version of an excipient which is recognised to have the same chemical composition and is covered by the same general monograph, but which differ in one or more attributes that may qualify its performance and use.

GRAS

Generally Recognized as Safe

GSP

Good storage practices

GTDP

Good Trade and Distribution Practices