Good Automated Manufacturing Practices
Good Distribution Practice
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]
Impurities present in the finished dosage form that may cause changes to the genome. [12]
Good Engineering Practices
Grocery Manufacturers Association
Genetically Modified Organism
Good Manufacturing Practices
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]
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]
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.
Generally Recognized as Safe
Good Storage Practices
Good Trade and Distribution Practices
Guidance is a term commonly used by the FDA to represent the Agency's current thinking on a particular subject.
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 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.