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Essential Considerations for Establishing a Quality Management System
in Cell & Gene (C&GT) Therapy Start-Up Companies

Image of Essential-Considerations-for-Establishing-a-Quality-Management-System-in-Cell-Gene-C&GT-Therapy-Start-Up-Companies.
As cell therapy continues to emerge as a promising field in medical science, start-up companies venturing into this arena must prioritize the establishment of robust Quality Management Systems (QMS). These systems ensure compliance with regulatory standards, maintain product quality, and foster a culture of continuous improvement. Here are key elements to consider when setting up a QMS for cell therapy start-ups:

10 Key Steps to start a PMO in Pharmaceutical Startups

  1. Regulatory Compliance: Understand and adhere to regulations set forth by regulatory authorities such as the FDA (in the U.S.), EMA (in Europe), and other relevant agencies. Compliance with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and Good Clinical Practices (GCP) is essential.
  2. Document Control: Implement procedures for document creation, review, approval, distribution, and storage. This ensures that all documents related to manufacturing processes, protocols, and standard operating procedures (SOPs) are accurate, up-to-date, and easily accessible.
  3. Risk Management: Identify, assess, and mitigate risks associated with cell therapy manufacturing processes. Develop risk management plans to address potential hazards, including contamination, process failures, and supply chain disruptions.
  4. Personnel Training: Provide comprehensive training programs for employees involved in cell therapy manufacturing. Training should cover GMP regulations, QMS procedures , SOPs, safety protocols, and specialized techniques related to cell culture, manipulation, and characterization.
  5. Facility Design and Maintenance: Design manufacturing facilities to meet the specific needs of cell therapy production, including cleanroom specifications, environmental monitoring systems, and equipment validation. Implement preventive maintenance programs to ensure equipment reliability and product quality.
  6. Supplier Management and Qualification: Establish criteria for selecting and qualifying suppliers of raw materials, reagents, and ancillary products used in cell therapy manufacturing. Conduct supplier audits and evaluations to ensure the consistent quality of incoming materials.
  7. Product Characterization and Testing: Develop robust analytical methods for characterizing cell therapy products and verifying their identity, potency, purity, and safety. Implement in-process and release testing requirements to monitor and ensure product quality throughout the manufacturing process.
  8. Traceability and Record Keeping: Implement systems for tracking and documenting the entire lifecycle of cell therapy products, from donor tissue sourcing to final product distribution. Maintain accurate records of manufacturing processes, batch records, and adverse event reporting.
  9. Continuous Improvement: Foster a culture of continuous improvement by establishing mechanisms for monitoring, measuring, and analyzing QMS performance metrics. Implement corrective and preventive action (CAPA) processes to address deviations, non-conformities, and opportunities for improvement.
  10. Audits and Inspections: Prepare for regulatory audits and inspections by conducting internal audits and mock inspections to assess QMS effectiveness, compliance, and inspection readiness. Address findings promptly and implement corrective actions, as necessary.
By considering and incorporating these essential elements into the Quality Management Systems, cell therapy start-up companies can establish a strong foundation for manufacturing safe, effective, and compliant products that hold the potential to transform healthcare and improve patients' lives.
At Dahlia, our team of industry experts brings proven experience in establishing Quality Management Systems (QMS). We are equipped to support and collaborate with Cell & Gene Therapy companies in assessing, establishing, and enhancing suitable Quality Management Systems.

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Contact us today to discover how we can empower your organization with effective Quality Management Solutions that drive excellence and compliance.
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Dahlia Pharma Biotherapeutics Advisors Science

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