ASRM Cellular and Gene Therapy Accreditation 

Accreditation Application

I. Mission

Our mission is to advance the field of cellular and gene therapy by ensuring the highest standards of quality, safety, and compliance in the collection, processing, and administration of stem cell and gene therapy products. We are dedicated to fostering a culture of excellence and continuous improvement, enhancing patient outcomes, and contributing to the development of innovative and life-saving therapies. Through rigorous accreditation processes, we aim to support labs in achieving and maintaining these standards, ultimately promoting trust and confidence among patients, healthcare providers, and regulatory bodies worldwide.

II. Objectives

• Ensure Quality and Safety: Implement and uphold rigorous standards for quality and safety in all aspects of cellular and gene therapy, including collection, processing, storage, and administration.

• Promote Continuous Improvement: Foster a culture of continuous improvement through regular internal audits, management reviews, and adherence to best practices in quality management systems.

• Support Regulatory Compliance: Ensure that accredited labs comply with all relevant local, national, and international regulations, simplifying the regulatory audit and inspection processes.

• Enhance Operational Efficiency: Encourage the use of standardized procedures and efficient workflows to optimize resource utilization and improve lab productivity.

• Advance Research and Development: Support high-quality research and development activities by ensuring that labs have the necessary accreditation to attract funding and collaboration opportunities.

• Improve Patient Outcomes: Enhance patient safety and satisfaction by ensuring that accredited labs provide reliable and effective cellular and gene therapy products.

• Build Trust and Credibility: Establish accreditation as a mark of excellence and reliability, promoting trust and confidence among patients, healthcare providers, and regulatory authorities.

• Facilitate Market Competitiveness: Help labs gain a competitive edge in the marketplace by achieving accreditation, thereby demonstrating their commitment to high standards of quality and safety.

• Foster Collaboration: Promote collaboration between accredited labs and other research institutions, healthcare providers, and industry partners to advance the field of cellular and gene therapy.

• Provide Ongoing Support: Offer continuous support and guidance to accredited labs to help them maintain compliance and continuously improve their operations and patient care.