# 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.

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

The company that operates a system decides how it is classified; we do not classify our customers' systems. The PIC/S guidance document [PI 041-1](https://picscheme.org/docview/4234) expects these regulated users, as it calls them, to keep an inventory of all computerised systems in use, with an assessment of the function and criticality of each system and its data. It gives three example levels: direct GMP/GDP impact, indirect impact and no impact. For manufacturing, Annex 11 of the EU GMP Guide says an up-to-date listing of all relevant systems and their GMP functionality should be available.

The term appears, undefined, in [PI 011-3](https://picscheme.org/docview/3444). It says retrospective validation might be justified if a non-GxP system is newly classified as a GxP system, so a classification is not fixed. It also says the reasoning behind critical or non-critical classifications should be documented, and that any risk potentially affecting GxP compliance should be clearly identified.

Our business applications for the pharma sector are intended for settings the operator classifies as non-GxP. We do not offer computer system validation for them: we produce no IQ/OQ/PQ documentation (see Validation) and do not follow a GAMP 5 approach (see GAMP). In one tender, a pharma company's own user requirements specification classified the portal it wanted built as non-GxP. That classification did not mean the portal had no requirements.

## 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).
- [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.
- [PIC/S](https://t10.de/en/glossary/pic-s): PIC/S, the Pharmaceutical Inspection Co-operation Scheme, describes itself as a non-binding, informal co-operative arrangement between regulatory authorities in the field of GMP for medicines.
- [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)
- [Out of the inbox: a knowledge platform for a pharma logistics provider](https://t10.de/en/blog/knowledge-platform-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)
- [Proof of delivery in pharma logistics: matched to the client, searchable in a portal](https://t10.de/en/blog/pod-handling-pharma-logistics)
- [total10 - software for e-commerce and pharma](https://t10.de/en/)
- [Bespoke software & business apps with Symfony](https://t10.de/en/symfony-development)

## Sources

1. [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
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
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