To receive a single copy of the draft guidance - Draft Guidance for Industry: Current Good Tissue Practice
(CGTP) and Additional Requirements for Manufactures of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Availability, write: Office of Communication, Training, and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-1448.
With over 100,000 clients worldwide, CRYO-CELL is accredited by the AABB and believes the company is the first private cord blood bank to operate in a newly constructed state-of-the-art current Good Manufacturing Practice and Good Tissue Practice
(cGMP/cGTP)-compliant facility, well in advance of newly established Food and Drug Administration regulation.
.to determine compliance under applicable requirements, including; (1) that human cells, tissues, or cellular or tissue-based products are obtained by the establishment legally; (2) that donor eligibility and donor medical history interviews are based on accurate information that was not provided or obtained in a fraudulent manner; and (3) current good tissue practice
Entitled "Current Good Tissue Practice
for Human Cell, Tissue and Cellular and Tissue-Based Establishments: Inspection and Enforcement," the rule requires manufacturers to recover, store, label, package and distribute human cells, tissues and cellular and tissue-based products (HCT/Ps) in a way that prevents the introduction, transmission, or spread of communicable diseases.
For example, we have collaborated with FDA in the past year to develop good tissue practice
guidelines for eye banking which, when finalized will work well for all parties involved in the process."
CryoLife said it does not believe the costs to make corrections will be significant and, that in fact the changes have the potential to benefit the company by upgrading its processing in anticipation of future Good Tissue Practice
requirements expected to be issued this year by the FDA.
To comply with the regulation, HCT/Ps must undergo donor screening and testing for communicable disease, and manufacturers must follow current Good Tissue Practices
MiMedx Group provided additional background and context to certain points, including third party statements, in an article published by The Wall Street Journal on August 14, 2018: MiMedx products are manufactured according to current Good Tissue Practices
standards, pursuant to the FDA regulations specified in 21 CFR 1271, which are the requirements and guidelines the Company must follow.
The new 21 CFR Part 4 regulations define the requirements for HCT/P quality systems and Good Tissue Practices
in Part 1271.
The Food and Drug Administration (FDA) is seeking comments from the tissue transplant community on the agency's information collection regulations related to human cells, tissues, and cellular and tissue-based products (HCT/Ps) involving establishment registration and listing using Form FDA 3356; eligibility determination for donors; and current good tissue practices
The 4th annual "FDA and the changing paradigm for HCT/P regulation" provides updates from industry leaders to aid in compliance with the Food and Drug Administration's tissue regulations and to assure good tissue practices
in the lab.
The ESI hES cell lines were derived using procedures and documentation that are in compliance with current Good Tissue Practices
(cGTP) and current Good Manufacturing Practices (cGMP), are free of animal feeder cells and have been assessed for pluripotency and karyotypic stability.