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.
The event began with a survey to gain an impression of those present. The participants represented a broad range of GxPs, different types of companies and different levels of experience. The questions produced many insights, including:
- What we enjoy most about working in QA: a variety of tasks, cooperation and teamwork, helping people, solving problems and bringing structure.
- Our greatest challenges: people management and persuasion, quality culture and management support, and time pressure and priorities.
The panellists—Karin Baas (Good Clinical Practice), Christine Mitchell (Good Laboratory Practice), Hans De Koning (Good Manufacturing Practice), Henrieke de Bie (Good Pharmacovigilance Practice), and Hans de Raad (Information Technology)—each gave a short presentation providing background on the regulatory definitions and QA requirements in their respective GxP areas. Coree Forman chaired the panel discussion.
After lunch, the discussions continued on the basis of questions from the chair, the panellists and the audience. They covered several topics, including:
• The roles and responsibilities of QA under different GxP guidelines (GCP, GLP, GMP and GVP) in relation to audits and inspections, supplier qualification and other areas.
• The balance between QA independence and operational involvement.
• Expectations of QA professionals regarding IT, validation and regulations such as the General Data Protection Regulation (GDPR).
• The boundaries between quality assurance, quality control and quality management.
Participants gained technical knowledge about other GxP areas, but the shared importance of soft skills and critical thinking for QA professionals stood out in particular.
It was an enjoyable and educational day!