GxP – explained simply

L for Laboratory → Good Laboratory Practice (GLP)

C for Clinical → Good Clinical Practice (GCP)

M for Manufacturing → Good Manufacturing Practice (GMP)

D for Distribution → Good Distribution Practice, (GDP)

GxP (Good x Practice) is a quality standard relevant across various areas of the life sciences industries. This includes pharmaceuticals, medical technology, biotechnology, chemicals, food, and cosmetics. In all these industries, GxP guidelines ensure that products and processes meet strict quality and safety requirements – safeguarding consumers and guaranteeing product effectiveness.

GxP guidelines are issued by authorities and government bodies to ensure regulatory compliance in day-to-day operations. Two key examples are:

• The European Medicines Agency (EMA)
• The U.S. Food and Drug Administration (FDA)

In most cases, national regulatory authorities are responsible for checking compliance with established GxP guidelines and taking appropriate action in the event of non-compliance. In Germany, for example, this responsibility lies with the federal states.

GxP requirements define how work must be carried out across different stages of the product lifecycle – from cultivation (Agriculture) to testing (Laboratory). Their primary purpose is to ensure that industrially manufactured products are safe to consume or use. In addition, GxP aims to guarantee the reliable integration of all data relevant for product-related safety decisions.

In some cases, the abbreviation GxP is preceded by a “c” – which stands for current. It highlights that the guideline refers to the “current” or up-to-date good practice. In essence, there is no difference: the “c” simply serves as an informational extension.

Yaveon 365 is an ERP software solution designed specifically for the process industry. Its purpose: to support companies in meeting GxP regulations.

The following features help ensure compliance:

• Batch and serial number management
  Enables precise identification and traceability of products – essential for meeting GxP requirements.
• Documentation and compliance
  Supports electronic documentation of relevant production and quality control data. This ensures compliance with GxP demands for documentation and traceability.
• Quality management
  Integrated quality management functions allow companies to perform inspections, document results, and manage deviations – ensuring only products that meet quality standards are released.
• Approval and release workflows
  Provides tools for managing and documenting approval and release processes. This ensures that all necessary checks and releases are performed in line with GxP guidelines.
• Audit trails and electronic signatures
  Tracks system changes and actions via audit trails. Electronic signatures safeguard data authenticity and integrity – a core element of GxP compliance.
• Regular updates and validation
  Yaveon 365 is continuously updated to meet current legal requirements and industry standards. It also supports validation to guarantee systems run correctly and reliably.