Our glossary for guidance - Letter G

Measurement capability study

GAMP stands for Good Automated Manufacturing Practice and is the guideline for the validation of computerised systems in the pharmaceutical industry, both for manufacturers and suppliers.

GAP stands for "Good Agricultural Practices" and deals in particular with agricultural land use and animal husbandry. Not to be confused with the GAP audit (measurement of the difference between actual and target values of a quality management system).

A GAP audit or delta audit is a review conducted to determine whether a company meets the regulatory requirements in the medical device industry. It identifies potential gaps where the organisation is not in compliance with the required standards or regulations.

A GAP audit usually consists of the following steps:

• Preliminary meeting to clarify the objectives of the delta audit.
• Process analysis: Consideration of the actual state.
• Comparison of the analysis with the target state, identification of the gap(s)
• Proposing measures for change
• Implementing the measures, concluding the GAP audit in an audit report.

These audits enable those responsible to react to changes before they take effect. In addition, the necessary measures are identified and implemented in a targeted manner.

GCLP stands for "Good Clinical Laboratory Practice" and defines the requirements and rules for testing laboratories for preclinical and clinical studies.

GCP stands for "Good Clinical Practice" and refers to international ethical and scientific aspects and rules for conducting clinical studies.

Police Union, in german: Gewerkschaft der Polizei.

Japanese for "place of action"

Tour to find potential for optimisation.

Japanese for "See for yourself at the scene of the action".

‘Generic device group’ means a set of devices having the same or similar intended purposes or a commonality of technology allowing them to be classified in a generic manner not reflecting specific characteristics.

[Definition under (EU) 2017/745 Article 2 No. 7 also corresponds to definition under (EU) 2017/746 Article 2 No. 8]

Union for Education and Science.

GLP stands for "Good Laboratory Practice" and defines the organisational procedures and the conditions under which tests are planned, carried out and monitored.

GMP stands for "Good Manufacturing Practice". This refers to guidelines for quality assurance of production processes and their environment - in the production of medicinal products, active ingredients, cosmetics, food and feed.

The GMP requirements are divided into Part 1 and Part 2, along with the corresponding applicable annexes.

GMV is a humorous abbreviation and stands for "common sense".

Acronym for Good Storage Practice. This forms the guideline for the storage of pharmaceuticals. This regulation applies not only to manufacturers of pharmaceuticals, but also to importers, contract manufacturers and distributors, among others.

Shortcut for General safety and performance requirements.

[Definition of the term according to MDCG 2021-28 Acronyms]

GVP stands for "Good Pharmacovigilance Practice" and deals with the systematic monitoring of the safety of finished medicinal products for human and veterinary use. The aim here is to incidentally detect, assess and understand adverse effects and to initiate the appropriate measures to minimise risk.

GxP refers to all valid guidelines of "good working practice". These guidelines are used in particular in the medical, pharmaceutical and pharmaceutical industry.

The "G" stands for Good and the "P" stands for Practice, the "x" in the middle is replaced by the abbreviation of the corresponding area of validity.