# GDP

> Good distribution practice (GDP) is the part of quality assurance which ensures that the quality of medicinal products is maintained throughout all stages of the supply chain.

Original page: https://t10.de/en/glossary/gdp
Publisher: total10 GmbH, https://t10.de/en/glossary

That definition is taken from the [EU Guidelines on Good Distribution Practice of medicinal products for human use (2013/C 343/01)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52013XC1123(01)), which are based on Article 84 and Article 85b(3) of Directive 2001/83/EC.

The guidelines state that, under Article 80(g) of the directive, distributors holding a wholesale distribution authorisation must comply with GDP. So must manufacturers performing any distribution activities with their own products. People brokering medicinal products must be subject to certain provisions applicable to wholesale distributors. Other parties involved in distribution should also adhere to relevant sections, though the guidelines do not name those sections. According to the PIC/S guidance document [PI 011-3](https://picscheme.org/docview/3444), GDP sets out which compliance requirements apply to wholesaling and distribution.

For software, the passage that matters is section 3.3.1 on computerised systems. It says that before such a system is brought into use, appropriate validation or verification studies should demonstrate that it is capable of achieving the desired results accurately, consistently and reproducibly.

For more than ten years we have worked with a pharma logistics provider whose work is shaped by GDP, developing and maintaining business applications for its own use and for its clients, the pharma companies it serves. Where our case studies cite GDP sections, they do so as further reading, not as a statement about the software described.

## See also

- [GxP](https://t10.de/en/glossary/gxp): GxP is an umbrella term for the good practice guides and requirements of the regulated pharmaceutical sector, such as good manufacturing practice (GMP) and good distribution practice (GDP).
- [GMP](https://t10.de/en/glossary/gmp): Good manufacturing practice (GMP) is the part of quality assurance ensuring that medicinal products are consistently produced, imported and controlled to standards appropriate to their intended use.
- [Validation](https://t10.de/en/glossary/validation): In the EU GMP and GDP glossaries, validation is the action of proving that any procedure, process, equipment, material, activity or system actually leads to the expected results.
- [Pharma logistics](https://t10.de/en/glossary/pharma-logistics): Pharma logistics is the term we use for storing, transporting and delivering medicinal products and other pharma-sector goods, such as promotional material and supplies for patients.

## Where the term appears

- [Proof of delivery in pharma logistics: matched to the client, searchable in a portal](https://t10.de/en/blog/pod-handling-pharma-logistics)
- [Non-GxP in pharma: what we build, what we leave out and where our systems stop](https://t10.de/en/blog/non-gxp-pharma-logistics)
- [Out of the inbox: a knowledge platform for a pharma logistics provider](https://t10.de/en/blog/knowledge-platform-pharma)
- [Bespoke software & business apps with Symfony](https://t10.de/en/symfony-development)
- [Pharma IT services: Non-GxP software](https://t10.de/en/pharma)

## Sources

1. [Leitlinien vom 5. November 2013 für die gute Vertriebspraxis von Humanarzneimitteln (2013/C 343/01)](https://eur-lex.europa.eu/legal-content/DE/TXT/?uri=CELEX:52013XC1123(01)), Amt für Veröffentlichungen der EU (EUR-Lex), accessed 2026-11-06
2. [PI 011-3 Good Practices for Computerised Systems in Regulated GxP Environments (25. September 2007)](https://picscheme.org/docview/3444), PIC/S, accessed 2026-11-06