# 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).

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

GxP means the compliance requirements for all good practice disciplines in the regulated pharmaceutical supply chain, from discovery to post-marketing. PIC/S, an informal co-operative arrangement between regulatory authorities, defines it this way in the list of abbreviations of its guidance document [PI 011-3](https://picscheme.org/docview/3444). The [WHO guideline on data integrity](https://cdn.who.int/media/docs/default-source/medicines/norms-and-standards/guidelines/inspections/trs1033-annex4-guideline-on-data-integrity.pdf) calls GxP an acronym for a group of good practice guides for regulated pharmaceuticals, biologicals and medical devices. Its examples show what the 'x' stands for: good laboratory practice (GLP), good clinical practice (GCP), good manufacturing practice (GMP), good pharmacovigilance practices (GVP) and good distribution practice (GDP).

GxP is not confined to production. PI 011-3 names procurement, inventory control, storage and distribution among the activities that might be GxP-related, and says the list is not exhaustive.

When commissioning software, it pays to establish early whether the system will touch GxP-regulated processes. Another PIC/S guidance document, PI 041-1, expects the regulated user, the company operating the system, to keep an inventory of its computerised systems including an assessment of each system's function and criticality. Direct, indirect and no GMP/GDP impact are example levels, not a yes-or-no record.

That assessment is not ours to make: our business applications are intended for settings that the operator has classified as non-GxP (see Non-GxP). We do not issue certificates of GxP compliance.

## See also

- [Non-GxP](https://t10.de/en/glossary/non-gxp): Non-GxP describes a system that its operator does not classify as GxP-relevant; PIC/S guidance uses the term without defining it formally.
- [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.
- [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.

## 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)
- [Straight to the patient, without ever touching their data](https://t10.de/en/blog/ordering-microsites-pharma)
- [Ordering promotional material without losing control](https://t10.de/en/blog/promo-material-ordering-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)
- [Out of the inbox: a knowledge platform for a pharma logistics provider](https://t10.de/en/blog/knowledge-platform-pharma)
- [Proof of delivery in pharma logistics: matched to the client, searchable in a portal](https://t10.de/en/blog/pod-handling-pharma-logistics)
- [Bespoke software & business apps with Symfony](https://t10.de/en/symfony-development)
- [total10 - software for e-commerce and pharma](https://t10.de/en/)

## Sources

1. [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
2. [Introduction](https://picscheme.org/en/about-introduction), PIC/S, accessed 2026-11-06
3. [WHO Technical Report Series No. 1033, Annex 4: Guideline on data integrity (2021)](https://cdn.who.int/media/docs/default-source/medicines/norms-and-standards/guidelines/inspections/trs1033-annex4-guideline-on-data-integrity.pdf), World Health Organization (WHO), accessed 2026-11-06
4. [EudraLex Volume 4, Chapter 1: Pharmaceutical Quality System (in Kraft seit 31. Januar 2013)](https://health.ec.europa.eu/document/download/e458c423-f564-4171-b344-030a461c567f_en?filename=vol4-chap1_2013-01_en.pdf), Europäische Kommission, Generaldirektion Gesundheit, accessed 2026-11-06
5. [PI 041-1 Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments (1. Juli 2021)](https://picscheme.org/docview/4234), PIC/S, accessed 2026-11-06