Glossary

A nucleoside consisting of one guanine molecule linked to a D-ribose sugar molecule. The derived nucleotides, guanosine mono-, di-, and triphosphate (GMP, GDP, and GTP, respectively), are important in various metabolic reactions.

An individual who is authorized under applicable state or local law to give permission on behalf of a child to general medical care. 45CFR46.402 (e)

Graphical User Interface

General Use Requirements

Good Vigilance Practice

Global Warming Potential

Ground Water Under the Direct Influence of Surface Water

One or a combination of GCP, GMP, GLP, GDP – often used for everything of interest for the Regulatory Bodies. ‘x’, one of: Clinical, Manufacturing, Laboratory, Distribution.

Software entities which have a specific user defined business purpose that must meet the requirements of a GxP regulation.

Meeting all applicable pharmaceutical and associated life-science regulatory requirements.

A processing parameter, which has a direct impact on the quality of the product.

Computerized systems that are subject to GxP regulations. The regulated company must ensure that such systems comply with the appropriate regulation.

Refers to the underlying international life science requirements such as those set forth in the US FD&C Act, US PHS Act, FDA regulations, EU Directives, Japanese MHLW regulations, or other applicable national legislation or regulations under which a company operates.

Refers to the underlying international life science requirements such as those set forth in the US FD&C Act, US PHS Act, FDA regulations, EU Directives, Japanese MHLW regulations, or other applicable national legislation or regulations under which a company operates.

The underlying international pharmaceutical requirements, such as those set forth in the US FD&C act, US PHS Act, FDA regulations, EU Directives, Japanese regulations, or other applicable national legislation or regulations under which a company operates. These include but are not limited to:• Good Manufacturing Practice (GMP) (pharmaceutical, including Active Pharmaceutical Ingredient (API), veterinary, and blood)• Good Clinical Practice (GCP)• Good Laboratory Practice (GLP)• Good Distribution Practice (GDP)• Good Quality Practice (GQP)• Good Pharmacovigilance Practice• Medical Device Regulations• Prescription Drug Marketing Act (PDMA)

Organisms that have both male and female cells and therefore express both male and female characteristics.

Female parthenogenesis; after fertilization of the ovum, the male nucleus is eliminated and the haploid individual (described as gynogenetic) so produced possesses the maternal genome only.