Nyheter från OECD discussion group on GLP att distribuera till medlemmarna

Ingrid Sjöberg är vår kontaktperson med OECD när det gäller GLP Working Group och vi har nu fått nedan för kommentarer. Vänligen kontakta Ingrid Sjöberg ingrid.sjoeberg@telia.com med kommentarer för den 18/12 2018.


  1. Please identify other issues or concerns which you would like the 33rd Working Group meeting (6-7 March, 2019) to consider?
  2. Please provide feedback on whether the output to date from the Working Group – in response to issues raised by the Industry Group – has met industry’s expectations?

The webpage OECD GLP Frequently Asked Questions (FAQ) – Volume 4, was published on 28 February 2018.

The Advisory Document of the Working Group on Good Laboratory Practice on the Management, Characterisation and Use of Test Items, was published on 19 April 2018.

At the 32nd meeting (7-8 March, 2018), the Working Group discussed a draft of Volume 5 of the FAQ.  At the meeting, members provided comment, and a revised version of the document will be considered at the next Working group meeting in 2019.

A revised draft Advisory Document on Data Integrity – Definition and Guidance for Industry was developed by a drafting group under the Working Group. At the 32nd meeting, members reviewed the latest draft and members were invited to provide additional comments after the meeting. The document will be revised and sent to the Working Group members for comments. If following this round of review the document does not require any substantive changes, the revised draft will then be posted on the OECD’s public website for comment before a final draft is produced for circulation and approval by the Working Group and eventual publication.

The web page for GLP and Mutual Acceptance of Data has undergone a significant upgrade, and was posted on OECD’s public site in October 2018.

The Working Group agreed that the Secretariat should contact the members of the Industry Discussion Group and ask for their feedback, particularly as to whether the output from the Working Group had met industry’s expectations, and if there are any other issues or concerns they wish to raise for possible consideration by the Working Group (see box below).

Av sarqared 7 december, 2018

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