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The OECD GLP working party offered the GLP Industry Discussion group to share the internal training material used by the OECD GLP working party for training of GLP inspectors on the topic "CHARACTERISATION OF TEST ITEMS/ANALYSIS OF THE TEST ITEM IN VEHICLE".

The Training Material is intended for training of personnel from GLP Test Facilities as well as Sponsor Organizations and should be used taking into account the following disclaimer:

This material has been prepared to facilitate informed reflection. Please be aware that actual circumstances may vary, and - aside from excerpts taken from official OECD documents - it must not be regarded as regulatory guidance

The material is available for download here

In case of any questions please contact: holger.uhderoche.com

The "News from the GLP Monitoring Authorities" and the "Roundtable Q&A" for 2023, 2024 and 2025 have been published in the Activities -> SPAQA GLP Roundtable section

In addition, the presentation from the 2023 to 2025 SPAQA Annual Meetings are available in the SPAQA Members Only area.

The 2025 SPAQA Members Meeting and Conference was a great success

Venue: Restaurant im Park, Basel (Lange Erlen)

Date: September 23, 2025

Members Meeting was followed by the GLP Monitoring Authority Roundtable, a presentation of the CSV and GLP Working Groups, a presentation of a Guest Speaker and concluded by a discussion on Artificial Intelligence in a Quality Management System.

Networking possibilities galore

GLP Group: The GLP working group is headed by Holger Uhde, F. Hoffmann -La Roche. Holger's leadership of the group was confirmed at the 2024 SPAQA Annual Meeting. If you are interested in becoming a member of the group, please contact Holger at Holger.Uhderoche.com.

The next meeting of the group will be a virtual meeting on November 26, 2025 focusing on feedback from recent interactions between the OECD GLP working party and the industry.

CSV group: The CSV Group restated in 2025

For more information please contact Marion Capobianco at Marion.Capobiancopmi.com

GMP Group: currently no activities

NEW DOCUMENTS AVAILABLE

Finalized Documents

OECD Position Paper on GLP and IT security (OECD 25) released 02 December 2024

OECD Position Paper on Quality Improvement Tools and GLP (OECD 24) released 18 July 2022.

OECD Advisory Document on Quality Assurance and GLP (OECD 23) released 04 November 2022.

Further information on GLP from the OECD can be found here.

AGIT Guideline for the Acquisition and Processing of Electronic Raw Data in a GLP Environment (29.04.2025)

AGIT Guideline for the Validation of Computerized Systems (29.04.2025)

Further information on AGIT Documents can be found here.

News

Training material on "Test Items" prepared by OECD GLP working party available

Internal News

Annual Meeting 2025

News from the Working Groups

Recent OECD or AGIT releases

Contact

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