Certificates and Accreditations

FamiCord is dedicated to providing high-quality services of cell and tissue banking. The way in which umbilical cord blood and tissue are collected, transported, processed, and stored directly impacts the quality of stem cells and the chances of saving a life during transplantation. Our high standards are confirmed by certificates obtained by local authorities as well global organizations. The fact that as transplantation and cellular therapy clinics used cell products from our labs confirms that the way they were prepared by our bank meet the criteria for therapy. Additionally, we are the only private cord blood bank in Europe which provides cells utilized in innovative experimental therapies and clinical research.

All our labs needs to comply with local requirements for cord blood banking set by applicable authorities in the country they are located (Germany, Poland, Spain, Hungary, Portugal, Turkey, Romania, Switzerland, UK and United Arab Emirates).

Association for the Advancement of Blood and Biotherapies, AABB [formerly known as: American Association of Blood Banks)

Our commitment to excellence is underscored by the Accreditation of Association for the Advancement of Blood and Biotherapies (AABB) for our laboratories, which ensures compliance with the most stringent standards set for cord blood banking procedures. This accreditation, which we have held since 2007, guarantees adherence to the strictest quality standards established in the U.S. and applicable worldwide. The FamiCord Group’s accredited laboratories are located in Cantanhede (Portugal), Madrid, Budapest, and Warsaw.
Cellular Starting Material Association for the Advancement of Blood and Biotherapies

For many years the only use of stored cord blood/stem cells has been standard transplantation. With evolving science and research it is more frequently used as starting material for new category of drugs – cell and gene products or therapies (CGT) . The prestigious AABB accreditation is the result of an intensive evaluation process conducted by independent, professional auditors who verify whether the facility maintains a comprehensive quality management system for cellular starting material. The assessment is based on compliance with international standards set by the AABB, as well as local guidelines.

The AABB CSM accreditation confirms that the FamiCord Group is a trusted partner for companies seeking a banking partner in the provision of cellular starting material. It also enables the production of personalized cell therapies for clients banking umbilical cord blood. Among the laboratories within the FamiCord Group, the prestigious accreditation has been obtained by the facilities in Cantanhede, Girona, Madrid, and Warsaw.

All banks that achieve AABB and AABB CSM accreditation must undergo re-evaluation every two years.
The Joint Accreditation Committee ISCT-EBMT (JACIE)

The Joint Accreditation Committee ISCT-Europe & EBMT (JACIE) is Europe’s only official accreditation body in the field of haematopoietic cell transplantation and cellular therapy. It promotes high-quality patient care and medical and laboratory practice through a profession-led, voluntary accreditation scheme. As an accredited institution by JACIE, FamiCord adheres to global standards of quality in cellular therapy. JACIE’s accreditation encourages healthcare institutions to implement and maintain quality management systems that impact all aspects of their activities. Our accreditation not only demonstrates our commitment to continuous improvement but also ensures that we provide the highest standards in stem cell processing, translating into safety and efficacy for patients who received ATMP products from our facilities.

JACIE accreditation has been given to our lab in Germany.
Consent of the Main Pharmaceutical Inspector

The Consent of the Polish Chief Pharmaceutical Inspectorate is a crucial approval that enables us to manufacture Advanced Therapy Medicinal Products (ATMPs). This regulatory endorsement not only affirms our compliance with the highest standards of safety and quality but also allows us to contribute significantly to the field of clinical research and innovative experimental therapies.

With this consent, we are empowered to produce ATMPs that are used in clinical trials, paving the way for groundbreaking treatments that can address unmet medical needs. Our ability to develop and provide these advanced products positions us at the forefront of medical innovation, allowing researchers and healthcare professionals to explore new therapeutic avenues.

The consent of the Chief Pharmaceutical Inspectorate have been granted to the FamiCord Group laboratory in Warsaw.
Certificate of GDP compliance of a wholesale distributor

The Certificate of GDP Compliance for a Wholesale Distributor is a vital accreditation that verifies our adherence to Good Distribution Practice (GDP) standards. This certification ensures that our processes for the storage and distribution of pharmaceutical products meet the highest quality and safety requirements, safeguarding the integrity of the products we handle.

With this certificate, we are authorized to distribute a range of medicinal products, including Advanced Therapy Medicinal Products (ATMPs), ensuring that they are transported and stored under optimal conditions. This compliance not only reinforces our commitment to patient safety but also enhances our reputation as a trusted partner in the healthcare supply chain.

The Certificate of GDP Compliance for a Wholesale Distributor has been awarded to the FamiCord Group laboratory in Cantanhede.
Certificate of GMP compliance of a manufacturer

The Certificate of GMP Compliance for a Manufacturer is a critical accreditation that verifies our adherence to Good Distribution Practice (GDP) standards in the production of Advanced Therapy Medicinal Products (ATMPs). This certification ensures that our manufacturing processes meet the highest quality and safety requirements, crucial for safeguarding the integrity of the products we create.

With this certificate, we are authorized to manufacture ATMPs, enabling us to develop innovative therapies that can significantly impact patient care. The compliance with GMP standards ensures that all aspects of our production—from sourcing raw materials to the final product—are conducted under stringent quality controls, thus enhancing the safety and efficacy of the therapies we provide.

The Certificate of GMP Compliance for a Manufacturer has been awarded to the FamiCord Group laboratory in Cantanhede and Leipzig.
ISO 9001 standard for Quality Management System

In 2004, FamiCord facility in Warsaw, obtained certification of the quality management system ISO 9001:2000, specific to the umbilical cord stem cell collection, storage, and freezing procedures. The audit was conducted by Lloyd Register Quality Assurance, ensuring that our practices align with internationally recognized quality standards. This certification reflects our commitment to maintaining the highest level of quality in all our processes, reinforcing our dedication to the safety and efficacy of the stem cells we handle. It also serves as a benchmark for continuous improvement and operational excellence within our organization. The certificate is still maintained, now the scope of inspection has been expanded to include collection, procurement, freezing and storage of human stem cells.

Also, two laboratories from the FamiCord Group have successfully passed this audit – in Turkey and Portugal. This achievement reflects our unified approach to quality across all facilities, ensuring that we consistently deliver safe and effective cellular therapy products. By adhering to these standards, we reinforce our credibility in the industry and demonstrate our dedication to excellence in all aspects of our services.
ISO: 14001:2005 standard for Quality Management System satisfactory (QMS)

In 2011, the FamiCord Group proudly achieved compliance with the MSZ EN ISO 14001:2005 standard for Environmental Management Systems (EMS), reflecting our commitment to sustainable practices and environmental stewardship. Our Budapest laboratory is specifically recognized for maintaining this certification, demonstrating our proactive approach to minimizing environmental impact across our operations.

The three-year certification involves regular monitoring of our Environmental Management System, alongside our Quality Management System, ensuring that we consistently adhere to rigorous environmental standards. This auditing process is conducted by SGS Hungaria Kft., a reputable organization known for its thorough assessment practices. By prioritizing sustainability, we not only enhance our operational efficiency but also contribute positively to the communities and ecosystems we serve. The FamiCord Group remains dedicated to continuous improvement in our environmental performance, reinforcing our role as a responsible leader in the industry.