AABB Praises FDAs Work on Final
Good Tissue Practice Rule
Measure designed to improve human cell and
tissue
safety through broader regulation
BETHESDA, MD AABB commends the U.S. Food and Drug
Administrations (FDA) efforts to enhance industry safety with its
issuance of the final rule on current good tissue practice (CGTP).
The new regulations, entitled Current Good Tissue Practice for
Human Cell, Tissue, and Cellular and Tissue-Based Establishments,
require a broad range of human cells, tissues, and cellular and
tissue-based products (HCT/Ps) to be manufactured in compliance with
GTP standards.
We are pleased that the AABB Standards were one of several
organizational standards reviewed in preparation for determining the
provisions of this regulation, said Karen Shoos Lipton, CEO of
AABB. AABB supports the rule and is pleased that the regulations
set out general objectives rather than requiring specific
procedures. AABB strives to be certain that its Standards are
compatible with regulations and that all of the minimum FDA
requirements are included.
AABB has been setting voluntary standards for hematopoietic
progenitor cells since 1991. AABB began incorporating a quality
management system along with the rigorous technical requirements
into all of its standard setting activities in 1997. This concept of
quality and technical requirements is consistent with the practices
described in the CGTP. AABBs institutional members have been at the
forefront of meeting quality management systems and technical
requirements in blood banking, including setting standards for
hematopoietic stem cells. It has accredited more than 110
hematopietic progenitor cells services and 26 cord blood services.
AABB
Established in 1947, AABB (formerly known as the American
Association of Blood Banks) is an international, not-for-profit
association dedicated to the advancement of science and the practice
of transfusion medicine and related biological therapies. The
association is committed to improving health by developing and
delivering standards, accreditation and educational programs and
services that optimize patient and donor care and safety. AABB
membership consists of approximately 1,800 institutions and 8,000
individuals, including physicians, scientists, administrators,
medical technologists, nurses, researchers, blood donor recruiters
and public relations personnel. Members are located in all 50 states
and 80 countries.