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GxP explained simply

Published Jul 14, 2025
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What is GxP?

GxP stands for "Good Practices" and refers to a collection of guidelines, standards and regulations specifically developed to ensure quality and compliance in the production and manufacturing processes of the life sciences industry. These guidelines are crucial to ensure that products and processes are subject to strict quality controls

In this article:

What can the x in GxP stand for, for example?

"L" stands for "Laboratory" (Good Laboratory Practice, GLP)

"C" stands for "Clinical" (Good Clinical Practice, GCP)

"M" stands for "Manufacturing" (Good Manufacturing Practice, GMP)

"D" stands for "Distribution" (Good Distribution Practice, GDP)

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Who does GxP apply to?

GxP (Good x Practice) is a quality standard that applies to various areas of the life sciences industries. These include, in particular, the pharmaceutical, medical device, biotechnology, chemical, food and cosmetics industries. In all these industries, the GxP guidelines ensure that products and processes meet strict quality and safety requirements in order to guarantee consumer protection and product efficacy.

Who sets GxP guidelines?

The GxP guidelines are defined by authorities and governments and represent specifications for a compliant way of working. Two important examples are

  • the European Medicines Agency (EMA)
  • the US Food and Drug Administration (FDA)

Who checks that the defined guidelines are adhered to?

As a rule, the monitoring authorities of each country are responsible for checking the defined GxP guidelines and taking the necessary measures in the event of non-compliance. In Germany, monitoring is the responsibility of the federal states.

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Yaveon 365 ERP does justice to GxP requirements.

Our industry-specific ERP Yaveon 365 supports compliance with GxP regulations with its functions.

What is the aim of the GxP requirements?

The GxP requirements provide specifications for the working procedures at various "product stages, e.g. in cultivation (agriculture) and in testing (laboratory). The aim is to ensure that industrially manufactured products can be consumed safely. It is also about ensuring the integration of data that is relevant for product-related safety decisions.

How does cGxP differ from GxP?

In some cases, the abbreviation GxP is preceded by a "c" - it stands for "current". It is therefore a "current" or currently valid "good practice". Ultimately, there is no difference. It is purely an extension of information.

Yaveon 365: Industry-specific ERP for GxP-compliant processes

Yaveon 365 is an ERP software solution designed specifically for the process manufacturing industry. It aims to support companies in complying with GxP regulations.

The following features help with implementation:

  • Batch and serial number management: batch and serial number management helps to accurately identify and track products, which is essential for GxP compliance.
  • Documentation and compliance: The software supports the electronic documentation of relevant production and quality control data. This helps to meet the documentation and traceability requirements demanded by GxP guidelines.
  • Quality management: Yaveon 365 integrates quality management functions that enable quality inspections to be carried out, results to be documented and deviations to be managed. This enables companies to ensure that only products that meet quality standards are delivered.
  • Approval and release processes: The software offers functions for controlling and documenting approval and release processes. This ensures that all necessary checks and approvals are carried out in accordance with the GxP guidelines.
  • Audit trails and electronic signatures: The ERP solution includes audit trail functions that document changes and actions in the system. Electronic signatures can be used to ensure the authenticity and integrity of data, which is an important part of GxP compliance.
  • Regular updates and process validation: Yaveon 365 is regularly updated to ensure that the software meets current legal requirements and industry standards. The software also provides process validation support to ensure systems are working correctly and reliably.
Autor Stefan Klammler

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