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

Op vrijdag 29 november 2024 waren ongeveer 50 deelnemers aanwezig in de Eenhoorn te Amersfoort voor een GLP themadag over recente OECD GLP documenten.

Frans Brouwer, voorzitter van de GLP-commissie, zette de toon met een routekaart die ons leidde vanaf de invoering van de OESO-GLP's in 1981, gevolgd door enkele belangrijke mijlpalen, waaronder het consensusdocument over de validatie van computerised systems in 1995 (dat in 2016 werd bijgewerkt tot een adviesdocument nr. 17). In 2002 verscheen het consensusdocument voor de toepassing van GLP voor het beheer van multi-site studies (nr. 13) en in 2022 werd een adviesdocument over QA en GLP (nr. 23) gepubliceerd, samen met een position paper over instrumenten voor kwaliteitsverbetering en GLP (nr. 24). De vraag werd gesteld: waar gaan we in de toekomst heen en welke rol gaat AI spelen in ons dagelijks leven en in de life sciences research?

This 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 electronic format. Measures of IT security aim to protect electronic GLP data and applications against the specific hazards encountered in the computerised environment. Threats and attacks on systems containing GLP data and corresponding measures to ensure security of such systems are constantly evolving, especially for systems and services being provided over or interfacing the internet. Handling of IT security may be outsourced by test facilities to external service providers. However, the responsibility remains with the test facility. This position paper provides an overview of considerations regarding IT security and GLP test facilities.

It is available following this link:

https://www.oecd.org/content/dam/oecd/en/publications/reports/2024/12/oecd-position-paper-on-good-laboratory-practice-and-it-security_9772eecf/910b7bd2-en.pdf

Vrijdag 15 november was de DARQA GMP-themadag met als thema “Nieuwe marktintroductie. Is jouw product klaar voor de markt?”.

Het was een geslaagde dag met veel inspirerende presentaties.

Dank aan alle sprekers voor jullie bijdrage aan deze GMP-themadag.

V.l.n.r., Jelte-Maarten Penninks PMP® , Ayla Tasoz, Nynke Brouwer, Alexander Bijman, Fija Lagerwerf, Martinus de Jonge, Hans (J.P.) De Koning (dagvoorzitter), Wen Liem.

Dank namens de DARQA GMP-commissie.

This was the first DARQA day dedicated to Advanced Therapy Medicinal Products (ATMPs). We were joined by speakers not just from the Netherlands but also from the UK and Sweden. The day had a real GXP feel thanks to the input from all our DARQA committees.

Hans de Konning made sure that the day ran smoothly and that everyone had the opportunity to ask their questions.

Christine Mitchell (ChrisalisQAdvice) gave a general introduction to ATMPs and how they are classified. She also discussed some TIPs for getting advice from the EMA and where you could find general information on their website. She also pointed out the need for risk assessment and a good robust strategy for the drug development path to avoid surprises and additional work along the way (“Begin with the end in mind” Stephen Covey).

Ion Tcacencu (Venn Life Sciences) gave an interesting presentation relating to the pre-clinical side. He also emphasised the need for a risk-based strategy and indicated that specific animal disease models may be required for this work. Although for safety studies Good Laboratory Practice should apply, he indicated that there have been market approvals for some products where the studies were not all performed in a GLP endorsed test facility.

Flow-cytometry is often used to both characterize ATMPs and also for assessment of samples taken from subjects during the clinical trials. Marie Geerlings (Ardena) gave a very clear overview of how flow cytometry works and some valuable TIPs for auditing this type of analysis.

Thilo Buck (Progress Experts in Life Sciences) took us up to the lunch with a presentation on Good Manufacturing Practices and Beyond: Essential Regulatory insights for ATMPs. Although there is a specific GMP guidance for ATMPs there are still some grey areas for example how should ANNEX I be applied for ATMPs. He gave the audience a great overview of the different regulations that need to be considered.

After lunch we continued with the theme of manufacturing. Marc Kamp (Kite Pharma) Presented some real-life situations relating to both manufacturing of ATMPs and the logistics behind the transport etc. This can be quite complex as it often involves personalized drugs and transport across the globe. For ATMPs it is essential that the time for manufacture is reduced to the absolute minimum to ensure the timely transfer back into the patient.