# What is Good Laboratory Practice?

> The term Good Laboratory Practice (GLP) describes the formal framework for conducting safety studies.

- Source: https://info-pharma.de/en/glp/
- Language: English (UK)
- Last updated: 2023-07-24
- Section: Home › Regulatory Requirements › GLP
- Deutsche Fassung: https://info-pharma.de/glp/index.html.md

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## Definition of the term

The term **Good Laboratory Practice** (**GLP**) can be understood as a formal framework for conducting safety studies. Particularly for chemicals, pharmaceutical and biotechnological medicinal products, new **medicines** and food additives, **Good Laboratory Practice** (**GLP**) is required by law and is regularly verified through inspections ordered by the authorities.[1]

## What do the GLP principles state?

The regulations of **Good Laboratory Practice** relate mainly to specific tests on substances and preparations, which are to be carried out in compliance with the GLP principles. The results of these non-clinical and experimental studies make it possible to assess their potential hazards to humans and the environment.[2]

The [**regulatory requirements**](https://info-pharma.de/en/regulatorische-anforderungen/) of **Good Laboratory Practice** set out the organisational processes and the conditions under which laboratory studies are carried out and monitored. In addition, the **GLP** principles specify the form in which the studies are to be documented and reported. Studies conducted in accordance with **GLP** regulations are usually assigned a Klimisch score of 1.[3]

## Requirements for laboratory management

In addition to the common procedures of **quality management**, laboratories must first introduce or develop a system that enables continuous quality control and smooth workflow management. Important aspects[4] here include:

- Filing and archiving of documents within the framework of the [**GxP** requirements](https://info-pharma.de/en/gxp/)
- Smooth communication between **third parties** and the various internal bodies
- Comparison of defined work steps with actual practice
- Results of external assessments and possible improvements
- Customer product reviews
- Preventive measures for weak points
- Training status of personnel

## GLP-compliant quality management systems

In view of today's **decentralisation** of the market and the increase in collaborations, companies face major challenges in the context of quality assurance. Special quality management or **document management systems** provide a remedy here. Standardised processes and options for connecting to existing IT systems make quality controls easier and allow quality gaps to be identified more quickly. The resulting savings in time and resources can help to drive the development of a product forward more efficiently.[5]

## Sources

[1] Cairns, D. 2012. „ Pharmaceutical Press“. Essentials of Pharmaceutical Chemistry, 320.

[2] Weinberg, Sandy, Hrsg. 2002. Good laboratory practice regulations. Informa Medical.

[3] Weinberg, Sandy, Hrsg. 2002. Good laboratory practice regulations. Informa Medical.

[4] Große, Jana, Ulrike Ruch, und Gudrun Tiedemann. 2017. „Qualitätsmanagement bei neu gegründeten Life-Science-Unternehmen“. In Life Science Venturing, 97–116. Wiesbaden: Springer Fachmedien Wiesbaden.

[5]Gamp good practice guide: Validation of laboratory computerized systems. 2005. International Society of Pharmaceutical Engineering.