Welcome to DARQA!
The Association aims to serve as a platform for developments regarding quality, quality systems, and quality policy within organizations and institutions operating in the fields of medical and pharmaceutical science, in the broadest sense of the term.
It seeks to achieve this objective by, among other things:
a. Exchanging information and insights regarding current quality systems, GxP-relevant guidelines and directives from government bodies (including the EMA and MHRA), and ISO standards;
b. Monitoring, promoting, and—where possible—influencing developments in this field;
c. Enhancing the expertise of members in the areas of quality and quality policy;
d. Maintaining and fostering contacts with individuals and institutions within government and other organizations whose activities intersect with DARDA’s field of work.
Events
News
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DARQA Spring Event 2026: AI in Practice across GCP, GLP and GMP
Details: DARQA Spring Event 2026: AI in Practice across GCP, GLP and GMPDARQA’s 2026 Spring Event explored practical AI across GCP, GLP and GMP, focusing on accountable judgement, evidence readiness, digital sovereignty and human collaboration.
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Report on the GLP Theme Day – Quality Meets Security: Bridging GLP Principles and IT Practice
Details: Report on the GLP Theme Day – Quality Meets Security: Bridging GLP Principles and IT PracticeThe GLP Theme Day explored the connection between Good Laboratory Practice and IT security, with practical insights into data protection, audits, cyber incidents, backups and the human factor.
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Report on the 2025 GCP Theme Day – Revision 3 of ICH E6 GCP
Details: Report on the 2025 GCP Theme Day – Revision 3 of ICH E6 GCPThe GCP Theme Day explored implementation of ICH E6 GCP Revision 3 from the perspectives of sponsors, investigators, QA and the Dutch inspectorate.
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Report on the 2025 GMP Theme Day – Impurities in the Spotlight: GMP’s Dirty Secrets
Details: Report on the 2025 GMP Theme Day – Impurities in the Spotlight: GMP’s Dirty SecretsThe GMP Theme Day focused on impurities, from Contamination Control Strategy and extractables and leachables to CMO selection, technology transfer, Annex 22 and ICH Q5.
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Report on the GLP Committee Webinar – Principles in Practice
Details: Report on the GLP Committee Webinar – Principles in PracticeThis interactive GLP webinar covered internal audits, training, QA’s organisational role, practical interpretation of GLP rules, and the use and validation of AI.
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Report on the Programme Following the AGM, 11 April 2025 – Quality Within and Across the GxPs
Details: Report on the Programme Following the AGM, 11 April 2025 – Quality Within and Across the GxPsDuring the programme following the AGM, more than forty participants explored similarities and differences across GCP, GLP, GMP, GVP and IT within Quality Assurance.
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Report on the DARQA GLP Theme Day, 29 November 2024
Details: Report on the DARQA GLP Theme Day, 29 November 2024The GLP Theme Day covered recent OECD documents on QA and quality improvement, risk-based process audits, Root Cause Analysis, AI risks and practical machine-learning applications.
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Newly released OECD Position Paper on Good Laboratory Practice and IT Security
Details: Newly released OECD Position Paper on Good Laboratory Practice and IT SecurityThis week the OECD published the OECD Position Paper on Good Laboratory Practice and IT Security (No 25) Data generated according to Good Laboratory Practice (GLP) are increasingly generated and retained in…