DARQA

Author: Almira van den Heuvel

  • Report on the GLP Committee Webinar – Principles in Practice

    Machine translation: this English text was automatically translated from the original Dutch article. If anything is unclear or differs, please refer to the Dutch original.

    Event language: This event was held in Dutch.

    On Thursday 5 June 2025, around 25 people took part in an interactive webinar on applying the GLP principles in a QA professional’s day-to-day work. 

    After a brief round of introductions by the GLP Committee, the composition of the group was surveyed: how many years of GLP experience participants had, the fields in which they worked, and so on. 

    A large proportion of the participants had many years of GLP experience and worked mainly in biotechnology and pharmaceuticals. 

    Participants could then choose from five topics. Topic 1 was not selected. Each chosen topic was discussed in a breakout session, after which a short summary was presented to the full group. The feedback for each topic is reported below. 

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  • Report on the Programme Following the AGM, 11 April 2025 – Quality Within and Across the GxPs

    Machine translation: this English text was automatically translated from the original Dutch article. If anything is unclear or differs, please refer to the Dutch original.

    Event language: This event was held in Dutch.

    We may think that we speak the same language when it comes to Quality Assurance (QA). But did you know that a “Principal Investigator” means something very different in GLP than it does in GCP? Did you know that GVP uses the term internal “audits”, while GMP uses “self-inspections”? Or that a “site” in GMP is completely different from a “site” in GCP?

    On 11 April 2025, more than 40 participants joined DARQA’s discussion on “Quality Within and Across the GxPs”. The meeting was intended to explore the similarities, while also celebrating the differences between the GxPs.

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  • Report on the DARQA GLP Theme Day, 29 November 2024

    Report on the DARQA GLP Theme Day, 29 November 2024

    Machine translation: this English text was automatically translated from the original Dutch article. If anything is unclear or differs, please refer to the Dutch original.

    Event language: This event was held in Dutch.

    From Good to Great – GLP, Quality Assurance and Quality Improvement Tools 

    On Friday 29 November 2024, around 50 participants gathered at De Eenhoorn in Amersfoort for a GLP Theme Day about recent OECD GLP documents.

    Frans Brouwer, chair of the GLP Committee, set the scene with a roadmap that took us from the introduction of the OECD Principles of GLP in 1981 through several important milestones. These included the consensus document on the validation of computerised systems in 1995, which was updated as Advisory Document No. 17 in 2016. The consensus document on applying GLP to the management of multi-site studies, No. 13, appeared in 2002. In 2022, Advisory Document No. 23 on QA and GLP was published, together with Position Paper No. 24 on quality-improvement tools and GLP. The question was raised: where are we heading in the future, and what role will AI play in our daily lives and in life-sciences research?

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