# 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.

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

[Commission Directive (EU) 2017/1572](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017L1572) sets out this definition. It covers medicinal products for human use whose manufacture or import requires an authorisation under Article 40 of Directive 2001/83/EC. The European Commission collects its GMP guidelines in [EudraLex Volume 4](https://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-4_en), the EU GMP Guide, which contains references to the applicable legislation and guidance for interpreting GMP for human and veterinary medicinal products. Chapter 1 of the guide says GMP applies across the lifecycle: from the manufacture of investigational medicinal products, via technology transfer and commercial manufacturing, through to product discontinuation.

For software, the relevant part of the guide is Annex 11, which applies to all forms of computerised systems used as part of GMP-regulated activities. For data, the PIC/S guidance document PI 041-1 is meant to help inspectorates interpret GMP and GDP requirements on good data management. It expects the operator's inventory of computerised systems to include an assessment of each system's function and criticality, with direct GMP/GDP impact, indirect impact and no impact as example levels (see Non-GxP).

What we build for the pharma sector ranges from an ordering platform for promotional material to software with which a logistics provider collects proofs of delivery from carriers and sorts them by client.

## 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).
- [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.
- [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.

## 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)
- [Proof of delivery in pharma logistics: matched to the client, searchable in a portal](https://t10.de/en/blog/pod-handling-pharma-logistics)

## Sources

1. [Richtlinie (EU) 2017/1572 der Kommission vom 15. September 2017 (Grundsätze und Leitlinien der Guten Herstellungspraxis für Humanarzneimittel)](https://eur-lex.europa.eu/legal-content/DE/TXT/?uri=CELEX:32017L1572), Amt für Veröffentlichungen der EU (EUR-Lex), accessed 2026-11-06
2. [EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines](https://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-4_en), Europäische Kommission, Generaldirektion Gesundheit, accessed 2026-11-06
3. [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
4. [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
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