Intercompany Quality & Regulatory Group
When Farbridge Pharma founder was living in Belgium, Stephanie Verbrugghe brought together a group of Cell Therapy professionals to discuss quality and regulatory challenges to learn from each other. It was composed of eight companies active in the development, manufacturing and testing of Cell Therapy products. The group shared experiences, challenges encountered, best practices, and spread regulatory vigilance updates to the community. They commented on the draft GMP guideline for Advanced Therapeutic Medicinal Products (ATMP) together and were invited to share their opinion at the Belgian Health Authorities offices in Brussels.
Implementation of a Compliant Quality Management System From Inception
This project took place in a Biotech startup. Together with the Company’s team, a Quality Management System (QMS), compliant with GMP and GDP, was implemented in 15 months and successfully accepted by the responsible Health Authorities. The QMS covered manufacturing, QC, QA, and logistics activities.
Analysis of Risks Related to Human Factors in Cell Therapy Manufacturing
In the early phases of Cell Therapy clinical trials, the majority of the realized operations depends on human activities. To control the related risk, we performed a risk analysis within a European company active in the development and production of Cell Therapy items. Our analysis was performed using the Bowtie model and an audit of the safety barriers in place. The deliverables of the project were a portfolio of mitigation measures to prevent human errors.
Root Cause Analysis Training
We trained American and European Pharmacovigilance (PV) employees of a Global Biopharmaceutical Company on Root Cause Analysis methods. Practical PV-related exercises were developed in order to coach staff on the handling of deviations and audit findings.
Implementation of a Quality Check in The Packaging Line
A daily quality control check was implemented in a company producing chemical drugs for Belgium and for exportation. Thanks to this additional barrier, three potential batch recalls were prevented.
Our Experience in Numbers
50 GxP audits performed (GMP, GDP, GPvP)
165 ATMP batches released
5 Successful inspections hosted
2 Quality Management System designs for Biotech companies
1 Quality & Regulatory synergy group created
Involved in the launch of 4 new Investigational Medicinal Products (IMPs)
Member of 6 Professional Associations
3 Languages: English, French, Dutch
“Stephanie has been a member of my team for several years as our Qualified Person and QA Manager. She participated actively in early phases of the company among set up and consolidation of quality management system. She was involved in many projects and product releases. She is a competent team player, passionate and dedicated to her assignments and customers.”