G
Gap Analysis
Identification of critical elements of a process which are available at the SU but are missing from the RU. [TRS 961 Annex 7, WHO]
Gas
Any substance that is completely gaseous at 1.013 bar and +20 °C or has a vapour pressure exceeding 3 bar at +50 °C. [EU GMP Guide, Annex 6]
Gene
A sequence of DNA that codes for one (or more) protein(s). [EU GMP Guide, Annex 2]
Gene Therapy Medicinal Product
A biological medicinal product which has the following characteristics:
Gene Transfer
A process to transfer a gene in cells, involving an expression system contained in a delivery system known as a vector, which can be of viral, as well as non-viral origin. After gene transfer, genetically modified cells are also termed transduced cells. [EU GMP Guide, Annex 2]
Genotoxic Carcinogen
Carcinogens which produce cancer by affecting genes or chromosomes. [ICH Q3C]
Good Clinical Practice (GCP)
A standard for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials, that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity and confidentiality of trial subjects are protected.
Good Distribution Practice (GDP)
GDP is that part of quality assurance which ensures that the quality of medicinal products is maintained throughout all stages of the supply chain from the site of manufacturer to the pharmacy or person authorised or entitled to supply medicinal products to the public. [EU GDP Guidelines]
That part of quality assurance that ensures that the quality of a pharmaceutical product is maintained by means of adequate control of the numerous activities which occur during the distribution process as well as providing a tool to secure the distribution system from counterfeits, unapproved, illegally imported, stolen, counterfeit, substandard, adulterated, and/or misbranded pharmaceutical products. [Good Distribution Practices for Pharmaceutical Products, WHO]
Good Engineering Practice (GEP)
Established engineering methods and standards that are applied throughout the project life-cycle to deliver appropriate, cost-effective solutions. [Main Principles for Pharmaceutical Products, WHO]
Good Laboratory Practice (GLP)
A quality assurance system based on national legal requirements (e.g. §19 of the German Chemicals Act or 21 CFR 211) and which is subject to governmental inspection. GLP guidelines regulate the organisation, the workflow and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, reported, and archived. The aim of GLP is to improve the quality and reliability of test data.
Good Manufacturing Practice (GMP)
The part of quality assurance which ensures that products are consistently produced and controlled in accordance with the quality standards appropriate to their intended use. [Directive 2003/94/EC]
That part of quality assurance which ensures that pharmaceutical products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization. [Good Distribution Practices for Pharmaceutical Products, WHO, Inspection, WHO]
Good Pharmacy Practice (GPP)
The practice of pharmacy aimed at providing and promoting the best use of medicines and other health care services and products, by patients and members of the public. It requires that the welfare of the patient is the pharmacist’s prime concern at all times. [Good Distribution Practices for Pharmaceutical Products, WHO, Inspection, WHO]
Good Storage Practice (GSP)
That part of quality assurance that ensures that the quality of pharmaceutical products is maintained by means of adequate control throughout the storage thereof. [Good Distribution Practices for Pharmaceutical Products, WHO]
Good Trade and Distribution Practice (GTDP)
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. [Good Distribution Practices for Pharmaceutical Products, WHO]
Gowning Qualification
A program that establishes, both initially and on a periodic basis, the capability of an individual to don the complete sterile gown in an aseptic manner. [Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing – cGMP, FDA]
Growth Promotion Test
Test performed to demonstrate that media will support microbial growth. [PIC/S PI 007-6]
Also referred to as fertility or nutritive properties test, which is performed on the media used during the sterility test to demonstrate that it is capable of supporting the growth of micro-organisms. [PIC/S PI 012-3]
Identification of critical elements of a process which are available at the SU but are missing from the RU. [TRS 961 Annex 7, WHO]
Gas
Any substance that is completely gaseous at 1.013 bar and +20 °C or has a vapour pressure exceeding 3 bar at +50 °C. [EU GMP Guide, Annex 6]
Gene
A sequence of DNA that codes for one (or more) protein(s). [EU GMP Guide, Annex 2]
Gene Therapy Medicinal Product
A biological medicinal product which has the following characteristics:
- it contains an active substance which contains or consists of a recombinant nucleic acid used in or administered to human beings with a view to regulating, repairing, replacing, adding or deleting a genetic sequence,
- its therapeutic, prophylactic or diagnostic effect relates directly to the recombinant nucleic acid sequence it contains, or to the product of genetic expression of this sequence. Gene therapy medicinal products shall not include vaccines against infectious diseases. [Directive 2001/83/EC]
Gene Transfer
A process to transfer a gene in cells, involving an expression system contained in a delivery system known as a vector, which can be of viral, as well as non-viral origin. After gene transfer, genetically modified cells are also termed transduced cells. [EU GMP Guide, Annex 2]
Genotoxic Carcinogen
Carcinogens which produce cancer by affecting genes or chromosomes. [ICH Q3C]
Good Clinical Practice (GCP)
A standard for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials, that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity and confidentiality of trial subjects are protected.
Good Distribution Practice (GDP)
GDP is that part of quality assurance which ensures that the quality of medicinal products is maintained throughout all stages of the supply chain from the site of manufacturer to the pharmacy or person authorised or entitled to supply medicinal products to the public. [EU GDP Guidelines]
That part of quality assurance that ensures that the quality of a pharmaceutical product is maintained by means of adequate control of the numerous activities which occur during the distribution process as well as providing a tool to secure the distribution system from counterfeits, unapproved, illegally imported, stolen, counterfeit, substandard, adulterated, and/or misbranded pharmaceutical products. [Good Distribution Practices for Pharmaceutical Products, WHO]
Good Engineering Practice (GEP)
Established engineering methods and standards that are applied throughout the project life-cycle to deliver appropriate, cost-effective solutions. [Main Principles for Pharmaceutical Products, WHO]
Good Laboratory Practice (GLP)
A quality assurance system based on national legal requirements (e.g. §19 of the German Chemicals Act or 21 CFR 211) and which is subject to governmental inspection. GLP guidelines regulate the organisation, the workflow and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, reported, and archived. The aim of GLP is to improve the quality and reliability of test data.
Good Manufacturing Practice (GMP)
The part of quality assurance which ensures that products are consistently produced and controlled in accordance with the quality standards appropriate to their intended use. [Directive 2003/94/EC]
That part of quality assurance which ensures that pharmaceutical products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization. [Good Distribution Practices for Pharmaceutical Products, WHO, Inspection, WHO]
Good Pharmacy Practice (GPP)
The practice of pharmacy aimed at providing and promoting the best use of medicines and other health care services and products, by patients and members of the public. It requires that the welfare of the patient is the pharmacist’s prime concern at all times. [Good Distribution Practices for Pharmaceutical Products, WHO, Inspection, WHO]
Good Storage Practice (GSP)
That part of quality assurance that ensures that the quality of pharmaceutical products is maintained by means of adequate control throughout the storage thereof. [Good Distribution Practices for Pharmaceutical Products, WHO]
Good Trade and Distribution Practice (GTDP)
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. [Good Distribution Practices for Pharmaceutical Products, WHO]
Gowning Qualification
A program that establishes, both initially and on a periodic basis, the capability of an individual to don the complete sterile gown in an aseptic manner. [Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing – cGMP, FDA]
Growth Promotion Test
Test performed to demonstrate that media will support microbial growth. [PIC/S PI 007-6]
Also referred to as fertility or nutritive properties test, which is performed on the media used during the sterility test to demonstrate that it is capable of supporting the growth of micro-organisms. [PIC/S PI 012-3]