G
GAMP

Good Automated Manufacturing Practices

GDP

Good Distribution Practice

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. [30]

Genotoxic Impurities

Impurities present in the finished dosage form that may cause changes to the genome. [12]

GEP

Good Engineering Practices

GMA

Grocery Manufacturers Association

GMO

Genetically Modified Organism

GMP

Good Manufacturing Practices

Good Distribution Practices (GDP)

General principles of appropriate practices to maintain the quality and traceability of pharmaceutical starting materials throughout the entire supply chain from the manufacturer to the end-user. [1]

Good Manufacturing Practices (GMP)

Minimum requirements for the quality management system, methods to be used in, and the facilities or controls to be used for the manufacture, processing, testing, packing, or holding of an excipient and its ingredients. Conformance to these minimum requirements, in part, assures that a drug (i.e., excipient, API, and drug products) will consistently meet quality standards and assure patient safety. [1] [16] [19]

Grade

A version of an excipient which is recognized 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

Guidance

Guidance is a term commonly used by the FDA to represent the Agency's current thinking on a particular subject.

Guide

Guide is a term commonly used by IPEC to differentiate between documents that are issued by regulatory Agencies. An IPEC guide is intended to be used as a support tool to further expand and/or clarify on guidance or guidelines, or lack thereof.

Guideline

Guideline is a term used by regulatory agencies and other organizations (e.g. ICH) providing guidance on the scientific or regulatory aspects of the development of medicines and applications for marketing authorization. Although guidelines are not legally binding, applicants need to provide justification for any deviations.