At the end of January, Medicines for Europe hosted the 20th Regulatory Affairs and Pharmacovigilance Virtual Conference. It consisted of 6 sessions with different topics. As a sponsor for this exciting event, Qualifyze took part in session four.
February 10, 2021
This session's topic was future quality systems. The panelists and speakers discussed and shared their insights on virtual inspections and Quality Management Maturity monitoring systems. Starting the session, Brendan Cuddy from the European Medicines Agency talked about the inspectorates' challenges due to the pandemic. Distant assessments are a useful tool to stick to GDP/GMP guidelines, though they will not replace on-site inspection outside the pandemic. So far, the EMA has received positive feedback from inspectors and the inspected companies on conduct and results. In the future, international authorities will be using distant assessments as a complement to on-site inspections.
Next was Cristina Baccarelli from the European Directorate for the Quality of Medicines & Healthcare (EDQM). She shared the EDQM's experience with real-time remote inspections. Baccarelli explained what to expect and what to think about when preparing and conducting a distant inspection. She also mentioned helpful tools. Finally, she agreed that remote audits could confirm GMP compliance but can't be equivalent to on-site audits. If you want to learn more about the preparation and conduction of remote audits, read our blog article here.
Stefan Gimmel from STADA Arzneimittel AG explained his industry view on remote audits. The industry is asking for a broad European alignment on GDP certificates and procedures for remote audits.
Lyle Canida from the U.S. Food and Drug Administration (FDA) presented the QMM Pilot Program, a system created to measure and rate Drug Substance and Drug Product manufacturers' Quality Management Maturity and ability to deliver high-quality drug products reliably and without disruption. This system is a way to incentivize manufacturers to take ownership of the quality of their products. He sees the importance for patients & consumers, the industry, and the FDA. The overall goal is to keep all sites in compliance and avoid drug shortages. Adding to this topic, David Gaugh from the Association for Accessible Medicines informed about QMM Ratings Systems. He explained the metrics, challenges, and critical considerations. Gaugh gave the industry view on the ratings system and emphasized that one global system is needed.
Finishing off the discussion, our Quality Manager Francisco Muñoz Calahorra explained Qualifyze's perspective on future quality systems. From our view as audit service providers, we recognize the more significant limitations of audits - both on-site and remote, to be related to the limited time and the necessary sampling of examples, the audit setting, collaboration from auditees, and more. Developments in Data processing tools, training, audit preparation, and execution can enhance the auditors' skills for audits in the future. He emphasized, however, that information sharing is the actual future. Keeping this in mind, Qualifyze creates an environment where all stakeholders are connected to share information. Francisco explained: “At Qualifyze, we want to be the key to putting all pieces together for safer and more sustainable supply chains.”
After his presentation, Francisco answered questions. One attendee asked if sharing information that different companies find in audits is going against the idea of joining multiple customer requests into one audit. Francisco explained: “When joining multiple requests and background information, we get a broader view of auditees. Audits could be only one of many sources of information to evaluate a QMS and identify risks.” Answering another question, Francisco emphasized that all stakeholders should see the benefit of transparent supply chains to share their maturity ratings. Having all data analyzed and trended for homogeneous ratings across all manufacturers maintains confidentiality.
The session was an excellent opportunity to learn first hand about the leading Health Authorities’ approach and experience with remote inspections, quality metrics, and quality management maturity indicators. It was also an exciting area for discussion about the industry representatives’ concerns. Overall, this was the perfect scenario to present Qualifyze’s innovative approach and vision of the future. We look forward to participating in future events of the Conference.
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