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Quality Policy

Xellera Therapeutics is committed to meeting our clients’ needs by providing the highest quality and safest products that are fit for their intended uses, and by complying with the licensing conditions of Licence for Manufacturer, the requirements of the current Good Manufacturing Practices (cGMP) and Clinical Trial Authorizations (CTA).

Quality Management System (QMS)

To ensure our Quality Policy is effectively implemented, we have designed our Quality Management System (QMS) to comply with the current Good Manufacturing Practices (cGMP) standards of Pharmaceutical Inspection Co-operation Scheme (PIC/S), European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA), as well as other relevant legislations and guidelines for cell and gene therapy products.

[qualityhexagon 1=”Standard Operating Procedures (SOPs)” 1image=”https://www.xelleratherapeutics.com/wp-content/uploads/2022/03/1-Standard-Operating-Procedures-2.jpg” 1desc=”” 2=”Training” 2desc=”” 4=”Management Commitment & Continual Improvement” 4desc=”” 3=”Quality Risk Management (QRM)” 3desc=”” 5=”Corrective and Preventive Action (CAPA)” 5desc=”” 6=”Audits and Reviews” 6desc=”” 7=”Authorized Person (AP) and Senior Management Oversight” 7desc=””]
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