# PIC/S PI 025-2: aide-memoire for inspecting medicinal gases

PIC/S PI 025-2 (25 September 2007) is the Pharmaceutical Inspection Co-operation Scheme aide-memoire for GMP inspections of medicinal gas manufacture at air separation units, filling stations and hospitals; on 23 October 2026 the PIC/S publications list still showed PI 025-2 as its aide-memoire on medicinal gases.

## The document

PI 025-2 is a 14-page aide-memoire. Its document history gives adoption by the PIC/S Committee on 30 May 2006 and entry into force on 1 September 2006; the revision of 25 September 2007 only changed the editor's co-ordinates. It was drafted by a working group set up in 2003 by the PIC/S Expert Circle on Medicinal Gases. Its stated purpose is to enable the effective planning and conducting of GMP inspections of medicinal gas manufacturing, making optimal use of limited inspection time. The document itself says that the manufacture of medicinal gases is regulated by the PIC/S GMP Guide and Annex 6.

## Scope

It describes three types of medicinal gas manufacturing that inspections should cover: air separation units, filling stations and the manufacture of medicinal gases in hospitals. Its main table pairs each area of operation with crucial questions and the supporting GMP chapters, from manufacturing authorisation, personnel and quality management to validation and qualification (DQ, IQ, OQ, PQ).

## Hospital addendum (section 6)

The addendum lists questions for inspectors to consider at hospitals, including:

- Responsibility: who is responsible for the manufacturing and the distribution of medicinal gases in the hospital, and the responsibility of the pharmacy (6.1).
- Equipment and maintenance: whether production equipment is released for use in manufacturing medicinal gases, with a qualification report; how preventive maintenance intervals are determined; how measuring devices are calibrated (6.2 and 6.3).
- Medicinal compressed air (6.6): the source, contamination and filtration of the air inlet; the risk of contamination, for example from the exhaust of the hospital vacuum system, often in the same compressor room; online monitoring of dew point; a back-up system.
- Medicinal oxygen from a storage tank (6.7): a dedicated mobile tank and a certificate of analysis from the supplier on delivery, a back-up system, and a validated method of backflow prevention in the line supplying the hospital.
- Quality control (6.8): specifications based on the European Pharmacopoeia; validated methods, especially for oil in air, specific to the compressor lubricating oil. It gives testing frequencies as examples, such as impurity testing twice a year if the equipment is qualified and maintained, oxygen content once a year, and microbiological testing of medicinal air twice a year with a limit of 10 cfu/m³.

## Status and points to watch

- On 23 October 2026 the PIC/S publications list showed the Aide-Memoire on Medicinal Gases, PI 025-2, among its publicly available documents for inspectors.
- Its introduction refers to the 2001 revision of GMP Annex 6. The EU Annex 6 now in use was adopted by the European Commission on 31 January 2010, and a concept paper on revising Annex 6, agreed by PIC/S on 14 January 2026, was in public consultation from 11 February to 11 April 2026.
- It is an inspector's checklist for medicinal gas manufacture in general, not a guide specific to oxygen 93 or PSA plants.

### Does PI 025-2 apply to medicinal gases made in hospitals?

Its scope includes the manufacture of medicinal gases in hospitals, with an addendum of questions on responsibility, medicinal air, oxygen storage and quality control. Whether hospital production needs a licence depends on national law.

### Is PI 025-2 a GMP requirement?

It is an aide-memoire to help inspectors plan and conduct GMP inspections. The document says medicinal gas manufacture is regulated by the PIC/S GMP Guide and Annex 6.

## Sources

- [PIC/S PI 025-2, Aide-Memoire: Inspection of Medicinal Gases (25 September 2007)](https://picscheme.org/docview/3034)
- [PIC/S, Publications list (read in a browser on 23 October 2026)](https://picscheme.org/en/publications)
- [EMA GMP/GDP IWG and PIC/S, Concept paper on the revision of Annex 6, Manufacture of Medicinal Gases (agreed by PIC/S on 14 January 2026)](https://picscheme.org/docview/10988)
- [European Commission, EudraLex Volume 4, Annex 6: Manufacture of Medicinal Gases (Brussels, 3 February 2010)](https://health.ec.europa.eu/document/download/b9dfcd18-73d2-45f8-a3a7-e4558fdc2d58_en?filename=2009_07_annex6.pdf)

Reviewed: 2026-10-23. Ultra Controlo engineering. https://library.ultracontrolo.com/standards/pics-pi-025-medicinal-gases/