From June 3 to 5, 2019, Beike Biotech ushered in the AABB international certification review on-site inspection. The certification officer for this time is AABB senior examiner Frances Ivester, who is responsible for all aspects of the on-site review.
AABB (Advancing Transfusion and Cellular Therapies Worldwide (AABB), formerly known as the American Association of Blood Banks, was renamed the Global Alliance for Advanced Blood Transfusion and Cell Therapy Technology in 2005. Founded in 1947, it is a non-profit international certification organization composed of people and institutions engaged in the blood transfusion and cell therapy industry. inherit; font-size: inherit; line-height: inherit; font-family: inherit; vertical-align: baseline;”>It is the setter of international blood and cell therapy industry specifications and an authoritative organization for industry certification.
The scope of its certification covers all-round high standards for collection, processing, storage, distribution and clinical application. At the same time, the certification process is extremely strict, and the review content is detailed to every work link and operation process.It is recognized by the industry as the most stringent, complete and professional international standard.
In this on-site review, AABB examiners strictly followed AABB’s current cell therapy service standards, taking the entire process of cell product collection, reception, preparation, testing, release, warehousing, and storage as clues. Through on-site observation, personnel interviews, document review, etc., they reviewed the personnel, equipment, materials, methods, environment and other related capabilities and qualifications required in each link.
During the review, inspector Frances Ivester inspected the operation and equipment facilities of Beike Biotech Shenzhen Cell Preparation Center, reviewed a large number of document records, and communicated with the operating staff. Frances Ivester’s rigorous attitude and rich experience won the respect of everyone present.
After three days of rigorous review, AABB certification officer Frances Ivester spoke highly of Beike Bio’s stem cell preparation and storage work, It is believed that the preparation, transportation, testing and other aspects of the four products comply with the current AABB cell therapy product standards and passed the on-site audit again.
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