# 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.

Original page: https://t10.de/en/glossary/pic-s
Publisher: total10 GmbH, https://t10.de/en/glossary

The scheme was established in 1995 as an extension to the Pharmaceutical Inspection Convention (PIC) of 1970. PIC/S states that, as of November 2026, it has 57 participating authorities from Europe, Africa, the Americas, Asia and Australasia. Its stated mission is to lead the international development, implementation and maintenance of harmonised GMP standards and quality systems of inspectorates in the field of medicinal products.

Two of its guidance documents come up throughout this glossary. [PI 011-3](https://picscheme.org/docview/3444), 'Good Practices for Computerised Systems in Regulated GxP Environments', is intended as a reference for regulated users, including their suppliers, as well as for regulatory inspectors and investigators. [PI 041-1](https://picscheme.org/docview/4234), 'Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments', is addressed to inspectorates: it aims to guide them in interpreting GMP/GDP requirements on good data management and in conducting inspections. PI 041-1 states that it is not mandatory or enforceable under law and is not intended to replace national legislation.

The suppliers PI 011-3 mentions include companies like ours: as a software supplier to pharma companies, we are among the readers it addresses. In our case studies we list the guideline sections relevant to the system in a further-reading section. These references are a signpost to the sources, not a summary, and say nothing about the software described.

## 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.

## 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)
- [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. [Introduction](https://picscheme.org/en/about-introduction), PIC/S, accessed 2026-11-06
2. [Mission, Vision and Values](https://picscheme.org/en/mission-vision-and-values), PIC/S, accessed 2026-11-06
3. [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
4. [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