# 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.

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

The [glossary of the EU GMP Guide](https://health.ec.europa.eu/document/download/e99884fd-2b52-470b-9453-10346ddb6cbd_en?filename=glos4en200408_en.pdf) adds that the proof is made in accordance with the principles of GMP. The GDP glossary defines a narrower term, 'qualification', as proving that any equipment works correctly and actually leads to the expected results. It notes that 'validation' is sometimes widened to incorporate qualification.

[Annex 11](https://health.ec.europa.eu/document/download/8d305550-dd22-4dad-8463-2ddb4a1345f1_en?filename=annex11_01-2011_en.pdf) of the EU GMP Guide and the GDP guidelines both address computerised systems. Annex 11 covers all forms of computerised systems used as part of GMP-regulated activities. It says the application should be validated and the IT infrastructure qualified. It adds that decisions on the extent of validation should be based on a justified and documented risk assessment. Section 3.3.1 of the GDP guidelines asks for appropriate validation or verification studies before such a system goes into use.

Annex 15 of the EU GMP Guide defines, among others, these qualification steps, each a documented verification:

- Installation Qualification (IQ) verifies that facilities, systems and equipment, as installed or modified, comply with the approved design and the manufacturer's recommendations.
- Operational Qualification (OQ) verifies that they perform as intended throughout the anticipated operating ranges.
- Performance Qualification (PQ) verifies that systems and equipment can perform effectively and reproducibly based on the approved process method and product specification.

We do not offer validation for the applications we build (see Non-GxP).

## See also

- [GDP](https://t10.de/en/glossary/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.
- [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.
- [GAMP](https://t10.de/en/glossary/gamp): GAMP, short for Good Automated Manufacturing Practice, is guidance published by ISPE on a risk-based approach to computerised systems in GxP environments.
- [QA](https://t10.de/en/glossary/qa): QA is short for quality assurance; in the EU, both good manufacturing practice (GMP) and good distribution practice (GDP) are defined as part of it.

## Where the term appears

- [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)
- [Pharma IT services: Non-GxP software](https://t10.de/en/pharma)
- [Stock alerts in pharma logistics: the customer asked for a web shop. We thought it through.](https://t10.de/en/blog/stock-alerts-pharma)
- [Proof of delivery in pharma logistics: matched to the client, searchable in a portal](https://t10.de/en/blog/pod-handling-pharma-logistics)
- [rollenrampe.de](https://t10.de/en/portfolio/rollenrampe-de)
- [FEAS Onlineshop](https://t10.de/en/portfolio/feas-onlineshop)

## Sources

1. [EudraLex Volume 4, Glossary](https://health.ec.europa.eu/document/download/e99884fd-2b52-470b-9453-10346ddb6cbd_en?filename=glos4en200408_en.pdf), Europäische Kommission, Generaldirektion Gesundheit, accessed 2026-11-06
2. [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
3. [EudraLex Volume 4, Annex 11: Computerised Systems (Revision 1, in Kraft seit 30. Juni 2011)](https://health.ec.europa.eu/document/download/8d305550-dd22-4dad-8463-2ddb4a1345f1_en?filename=annex11_01-2011_en.pdf), Europäische Kommission, Generaldirektion Gesundheit, accessed 2026-11-06
4. [EudraLex Volume 4, Annex 15: Qualification and Validation (in Kraft seit 1. Oktober 2015)](https://health.ec.europa.eu/document/download/7c6c5b3c-4902-46ea-b7ab-7608682fb68d_en?filename=2015-10_annex15.pdf), Europäische Kommission, Generaldirektion Gesundheit, accessed 2026-11-06