Quality Management
The highest standards for your safety — from donor selection to product delivery.
Quality Is Our Foundation
At CytoCare, we understand that cell products for research and therapy must meet the highest quality standards. Our comprehensive quality management system ensures that every single process step — from donor recruitment through leukapheresis to cryopreservation and delivery — complies with all applicable regulatory requirements.
We operate according to Good Manufacturing Practice (GMP) principles and align with the requirements of the Austrian authorities (AGES/BASG) as well as European directives for tissue establishments. Regular internal and external audits ensure the continuous improvement of our processes.
Certifications
Our Approvals & Standards
GMP Compliant
All manufacturing and processing operations comply with Good Manufacturing Practices.
AGES/BASG Approval
Approved by the Austrian Agency for Health and Food Safety.
EU Tissues Directive
Compliance with EU Directives 2004/23/EC and 2006/17/EC for tissue establishments.
Qualified Supply Chain
Temperature-controlled logistics and complete traceability of all products.
Our Pillars
The Pillars of Our Quality Management
Donor Qualification
Rigorous selection criteria, medical pre-screening and regular health checks for all donors.
Process Control
Standardised operating procedures (SOPs) and documented processes for every work step.
Traceability
Complete documentation and batch traceability from donor to recipient.
Continuous Improvement
Regular audits, CAPA management and systematic analysis of deviations.
Quality Control
In-process controls, final product testing and validated analytical methods for every cell product.
Training & Competence
Regular training sessions and qualification records for all personnel in GMP areas.