From June 3 to 5, 2019, Beike Biotech welcomed the AABB international accreditation re-assessment on-site audit. The auditor was AABB Senior Assessor Frances Ivester, who was responsible for the on-site audit of every aspect.
AABB (Advancing Transfusion and Cellular Therapies Worldwide, AABB), formerly known as the American Association of Blood Banks and renamed in 2005 to the Association for Advancing Transfusion and Cellular Therapies Worldwide, was founded in 1947. It is a non-profit international accreditation organization composed of professionals and institutions in the transfusion and cellular therapy fields, and is the authoritative body that develops industry standards and conducts industry accreditation in the international blood and cell therapy fields.
Its accreditation scope spans high-quality standards across collection, processing, storage, distribution, and clinical use. The accreditation process is extremely rigorous, with audit content drilling down to every workstep and operating procedure, and is widely recognized in the industry as the most stringent, comprehensive, and professional international standard.
During this on-site audit, the AABB assessor strictly followed the current AABB cellular therapy services standards. Using the entire workflow of cell product collection, receipt, preparation, testing, release, intake and storage as the framework, the audit verified — through on-site observation, personnel interviews, and document review — the personnel, equipment, materials, methods, environment, and other capabilities and qualifications required at each step.
During the audit, assessor Frances Ivester inspected on-site the operations and equipment and facilities of Beike Biotech's Shenzhen Cell Preparation Center, reviewed extensive document records, and engaged in conversations with on-duty staff. Frances Ivester's rigorous attitude and rich experience earned the respect of all present.
After three days of strict auditing, AABB assessor Frances Ivester gave high praise to Beike Biotech's stem cell preparation and storage work, finding that the preparation, transportation, and testing of the four products comply with the current AABB cellular therapy product standards, and that Beike Biotech once again passed the on-site audit.
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